@Article{info:doi/10.2196/66978, author="Al-Fikri, Badeea Alhasan Ahmed and Alhammadi, Mesk and Arum, Chiedozie and Kaur, Mahima and Del Biondo, Kayla and Bani, Ibrahim and Mudenda, Victor and Vermund, H. Sten", title="Primary Tumors of the Brain and Central Nervous System in Adults and Children in Sub-Saharan Africa: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2025", month="Apr", day="24", volume="14", pages="e66978", keywords="tumor", keywords="cancer", keywords="brain", keywords="central nervous system", keywords="Africa", keywords="adults", keywords="children", keywords="scoping review", keywords="PRISMA", abstract="Background: In Sub-Saharan Africa (SSA), clinical and research investments for oncology screening, diagnosis, and therapy are exceedingly modest, compared to those in higher-income regions. Diseases that are difficult to prevent or treat, such as primary brain and central nervous system (CNS) tumors, are especially challenging in low-resource settings. Objective: In order to review and synthesize existing evidence to identify research and service gaps, we will conduct a scoping review to assess epidemiological data, clinical series, and health outcomes associated with brain and CNS tumors in SSA. Methods: This scoping review is guided by the Scoping Review Chapter of the JBI (Joanna Briggs Institute) Manual for Evidence Synthesis. We will search the following databases: Ovid MEDLINE, Embase, Cochrane Library, Scopus, references from salient publications, and the gray literature, the latter focused on the International Agency for Research on Cancer (IARC) and other major global health organizations. We will review titles and abstracts of potentially eligible studies and then full texts by 2 independent reviewers. We will include data from both primary and CNS cancers in persons of all ages. Data will be abstracted independently using piloted data extraction forms, and we will present results according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) and PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analyses Protocols) guidelines. Results: A total of 2857 articles were identified through our search strategy. After title and abstract screening, which was completed on February 23, 2025, by 2 independent reviewers, 222 studies met the eligibility criteria, while 2203 were excluded. Full-text screening began on March 3, 2025, and will be followed by data abstraction and analysis from April 15, 2025, until the end of May 2025. The study is expected to be completed by July 2025. Conclusions: SSA faces substantial challenges in the diagnosis and treatment of CNS tumors due to health care infrastructure limitations, insufficient reporting, and diagnostic supply shortages. The high fatality rates are attributed to underdiagnosis and misdiagnosis as infectious diseases, despite low incidence rates (IRs). The inadequate neurosurgery facilities and pathology resources further complicate the treatment and prognosis. A scoping review will investigate the true burden of underdiagnosis and gaps in outcomes in children and adults in SSA. Trial Registration: OSF Registries osf.io/57zvc; https://osf.io/57zvc International Registered Report Identifier (IRRID): PRR1-10.2196/66978 ", doi="10.2196/66978", url="https://www.researchprotocols.org/2025/1/e66978" } @Article{info:doi/10.2196/70522, author="Burgess, L. Jefferey and Beitel, C. Shawn and Calkins, M. Miriam and Furlong, A. Melissa and Louzado Feliciano, Paola and Kolar Gabriel, Jamie and Grant, Casey and Goodrich, M. Jaclyn and Graber, M. Judith and Healy, Olivia and Hollister, James and Hughes, Jeff and Jahnke, Sara and Kern, Krystal and Leeb, A. Frank and Caban-Martinez, J. Alberto and Mayer, C. Alexander and Osgood, Russell and Porter, Cynthia and Ranganathan, Sreenivasan and Stapleton, M. Heather and Schaefer Solle, Natasha and Toennis, Christine and Urwin, J. Derek and Valenti, Michelle and Gulotta, J. John", title="The Fire Fighter Cancer Cohort Study: Protocol for a Longitudinal Occupational Cohort Study", journal="JMIR Res Protoc", year="2025", month="Apr", day="22", volume="14", pages="e70522", keywords="firefighter", keywords="cancer", keywords="prospective cohort study", keywords="biomonitoring", keywords="protocol", abstract="Background: Firefighters are at an increased risk of cancer and other health conditions compared with the general population. However, the specific exposures and mechanisms contributing to these risks are not fully understood. This information is critical to formulate and test protective interventions. Objective: The purpose of the Fire Fighter Cancer Cohort Study (FFCCS) is to conduct community-engaged research with the fire service to advance the evaluation and reduction of firefighter exposures, along with understanding and mitigating effects leading to an increased risk of cancer and other health conditions. This involves establishing a long-term (>30 years) firefighter multicenter prospective cohort study. Methods: The structure of the FFCCS includes a fire service oversight and planning board to provide guidance and foster communication between researchers and fire organizations; a data coordinating center overseeing survey data collection and data management; an exposure assessment center working with quantitative exposure data to construct a firefighter job exposure matrix; and a biomarker analysis center, including a biorepository. Together, the centers evaluate the association between firefighter exposures and toxic health effects. Firefighter research liaisons are involved in all phases of the research. The FFCCS research design primarily uses a set of core and project-specific survey questions accompanied by a collection of biological samples (blood and urine) for the analysis of biomarkers of exposure and effect. Data and samples are collected upon entry into the study, with subsequent collection after eligible exposures, and at intervals (eg, 1-2 years) after enrollment. FFCCS data collection and analysis have been developed to evaluate unique exposures for specific firefighter groups; cancer risks; and end points in addition to cancer, such as reproductive outcomes. Recruitment is carried out with coordination from partnering fire departments and eligible participants, including active career and volunteer firefighters in the United States. Results: The FFCCS protocol development was first funded by the US Federal Emergency Management Agency in 2016, with enrollment beginning in February 2018. As of September 2024, >6200 participants from >275 departments across 31 states have enrolled, including recruit and incumbent firefighters. Biological samples have been analyzed for measures of exposure and effect. Specific groups enrolled in the FFCCS include career and volunteer structural firefighters, women firefighters, trainers, fire investigators, wildland firefighters, firefighters responding to wildland-urban interface fires, and airport firefighters. Peer-reviewed published results include measurement of exposures and the toxic effects of firefighting exposure. Whenever possible, research results are provided back to individual participants. Conclusions: The FFCCS is a unique, community-engaged, multicenter prospective cohort study focused on the fire service. Study results contribute to the evaluation of exposures, effects, and preventive interventions across multiple sectors of the US fire service, with broad implications nationally. International Registered Report Identifier (IRRID): DERR1-10.2196/70522 ", doi="10.2196/70522", url="https://www.researchprotocols.org/2025/1/e70522" } @Article{info:doi/10.2196/54625, author="Tang, Wen-Zhen and Mo, Shu-Tian and Xie, Yuan-Xi and Wei, Tian-Fu and Chen, Guo-Lian and Teng, Yan-Juan and Jia, Kui", title="Predicting Overall Survival in Patients with Male Breast Cancer: Nomogram Development and External Validation Study", journal="JMIR Cancer", year="2025", month="Mar", day="4", volume="11", pages="e54625", keywords="male breast cancer", keywords="specific survival", keywords="prediction model", keywords="nomogram", keywords="Surveillance, Epidemiology, and End Results database", keywords="SEER database", abstract="Background: Male breast cancer (MBC) is an uncommon disease. Few studies have discussed the prognosis of MBC due to its rarity. Objective: This study aimed to develop a nomogram to predict the overall survival of patients with MBC and externally validate it using cases from China. Methods: Based on the Surveillance, Epidemiology, and End Results (SEER) database, male patients who were diagnosed with breast cancer between January 2010, and December 2015, were enrolled. These patients were randomly assigned to either a training set (n=1610) or a validation set (n=713) in a 7:3 ratio. Additionally, 22 MBC cases diagnosed at the First Affiliated Hospital of Guangxi Medical University between January 2013 and June 2021 were used for external validation, with the follow-up endpoint being June 10, 2023. Cox regression analysis was performed to identify significant risk variables and construct a nomogram to predict the overall survival of patients with MBC. Information collected from the test set was applied to validate the model. The concordance index (C-index), receiver operating characteristic (ROC) curve, decision curve analysis (DCA), and a Kaplan-Meier survival curve were used to evaluate the accuracy and reliability of the model. Results: A total of 2301 patients with MBC in the SEER database and 22 patients with MBC from the study hospital were included. The predictive model included 7 variables: age (hazard ratio [HR] 1.89, 95\% CI 1.50?2.38), surgery (HR 0.38, 95\% CI 0.29?0.51), marital status (HR 0.75, 95\% CI 0.63?0.89), tumor stage (HR 1.17, 95\% CI 1.05?1.29), clinical stage (HR 1.41, 95\% CI 1.15?1.74), chemotherapy (HR 0.62, 95\% CI 0.50?0.75), and HER2 status (HR 2.68, 95\% CI 1.20?5.98). The C-index was 0.72, 0.747, and 0.981 in the training set, internal validation set, and external validation set, respectively. The nomogram showed accurate calibration, and the ROC curve confirmed the advantage of the model in clinical validity. The DCA analysis indicated that the model had good clinical applicability. Furthermore, the nomogram classification allowed for more accurate differentiation of risk subgroups, and patients with low-risk MBC demonstrated substantially improved survival outcomes compared with medium- and high-risk patients (P<.001). Conclusions: A survival prognosis prediction nomogram with 7 variables for patients with MBC was constructed in this study. The model can predict the survival outcome of these patients and provide a scientific basis for clinical diagnosis and treatment. ", doi="10.2196/54625", url="https://cancer.jmir.org/2025/1/e54625" } @Article{info:doi/10.2196/64611, author="Byrom, Bill and Everhart, Anthony and Cordero, Paul and Garratt, Chris and Meyer, Tim", title="Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials", journal="JMIR Cancer", year="2025", month="Feb", day="28", volume="11", pages="e64611", keywords="clinical trials", keywords="early phase", keywords="dose finding", keywords="patient-reported outcome", keywords="PRO", keywords="electronic patient-reported outcome", keywords="ePRO", keywords="PRO-CTCAE", keywords="adverse events", keywords="tolerability", keywords="optimal dose", keywords="cancer trials", keywords="dose toxicity", keywords="oncology", keywords="drug development", keywords="electronic collection", keywords="dose level", keywords="pharmacodynamic", keywords="cytotoxic chemotherapy drugs", keywords="cytotoxic", keywords="chemotherapy drug", keywords="life-threatening disease", keywords="Common Terminology Criteria for Adverse Events", doi="10.2196/64611", url="https://cancer.jmir.org/2025/1/e64611" } @Article{info:doi/10.2196/64662, author="Smits, M. Michelle J. and Bolman, W. Catherine A. and Mesters, Ilse and Lechner, Lilian", title="Blended Care Intervention for Cancer Aftercare in General Practice Centers: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2025", month="Feb", day="12", volume="14", pages="e64662", keywords="cancer aftercare", keywords="general practice", keywords="blended care", keywords="eHealth", keywords="randomized controlled trial", keywords="cost effectiveness", keywords="general practitioners", keywords="online intervention", abstract="Background: Combining effective eHealth programs with face-to-face consultations in general practice may help general practitioners care for survivors of cancer. Objective: This study protocol describes a 2-armed randomized controlled trial to evaluate the cost-effectiveness of a blended intervention integrating the Cancer Aftercare Guide in general practice centers (GPCs). Methods: A parallel-group design will compare an intervention group with a waiting list control group. Participants will be nested within GPCs and randomization will occur at the GPC level. The participants in the intervention group will receive a blended care intervention. In contrast, the participants in the waiting list control group will receive care as usual for the duration of this study and will receive the online intervention afterward. All participants will be asked to complete an online questionnaire at baseline, 6 months, and 12 months after baseline, measuring self-reported adherence to lifestyle recommendations, psychosocial well-being, and quality of life. A process evaluation and cost evaluation are also included in this study. The effects will be evaluated based on differences in residual change scores between intervention and control group participants, using multilevel linear regression analyses. Moreover, effect analyses will be supplemented with Bayes factor analyses. Finally, an economic evaluation will be conducted from a societal perspective and will include medical costs, productivity costs, and costs of the blended care intervention. Results: This study was funded in July 2020. Data collection started in August 2022 and is likely to be completed by April 2025. As of December 2024, a total of 127 participants have been included in this study, recruited across 26 GPCs in the Netherlands. Data analysis will commence once data collection is completed. Data analysis is estimated to start in the spring of 2025. The results will likely be published in 2026. Conclusions: The results will provide insight into the effectiveness of blended care and may be relevant to cancer aftercare, general practice, and the field of eHealth implementation in general. Potential challenges lie in recruitment due to the strain on the health care system since the COVID-19 pandemic. Trial Registration: ISRCTN ISRCTN12451453; https://www.isrctn.com/ISRCTN12451453 International Registered Report Identifier (IRRID): DERR1-10.2196/64662 ", doi="10.2196/64662", url="https://www.researchprotocols.org/2025/1/e64662" } @Article{info:doi/10.2196/60585, author="Mazzella-Ebstein, Marie Ann and Daly, Robert and Huang, Jennie and Bernal, Camila and Wilhelm, Clare and Panageas, S. Katherine and Holland, Jessie and Salvaggio, Rori and Ackerman, Jill and Cracchiolo, Jennifer and Kuperman, Gilad and Mao, Jun and Begue, Aaron and Barton-Burke, Margaret", title="Oncology Clinicians' Perspectives of a Remote Patient Monitoring Program: Multi-Modal Case Study Approach", journal="JMIR Hum Factors", year="2025", month="Jan", day="24", volume="12", pages="e60585", keywords="cancer", keywords="oncology", keywords="clinician end users", keywords="remote patient monitoring", keywords="digital health", keywords="implementation science", keywords="patient monitoring", keywords="patient access", keywords="care", keywords="communication", keywords="usability", keywords="functionality", keywords="survey", keywords="interview", keywords="efficiency", keywords="workflow", keywords="user", keywords="clinician support", abstract="Background: Remote patient monitoring (RPM) aims to improve patient access to care and communication with clinical providers. Overall, understanding the usability of RPM applications and their influence on clinical care workflows is limited from the perspectives of clinician end users at a cancer center in the Northeastern United States. Objective: This study aims to explore the usability and functionality of RPM and elicit the perceptions and experiences of oncology clinicians using RPM for oncology patients after hospital discharge. Methods: The sample included 30 of 98 clinicians (31\% response rate) managing at least 5 patients in the RPM program and responding to the mHealth usability between March 2021 and October 2021. Overall, clinicians responded positively to the survey. Item responses with the highest proportion of disagreement were explored further. A nested sample of 5 clinicians who responded to the study survey (30\% response rate) participated in interview sessions conducted from November 2021 to February 2022, averaging 60 minutes each. Results: Survey responses highlighted that RPM was easy to use and learn and verified symptom alerts during follow-up phone calls. Areas to improve identified practice changes from reporting RPM alerts through digital portals and its influence on clinicians' workload burden. Interview sessions revealed 3 main themes: clinician understanding and usability constraints, patient constraints, and suggestions for improving the program. Subthemes for each theme were explored, characterizing technical and functional limitations that could be addressed to enhance efficiency, workflow, and user experience. Conclusions: Clinicians support the value of RPM for improving symptom management and engaging with providers. Improvements to address RPM challenges include functional changes to enhance the program's utility, such as input from patients about temporal changes in their symptoms and technical resources for home monitoring devices. ", doi="10.2196/60585", url="https://humanfactors.jmir.org/2025/1/e60585" } @Article{info:doi/10.2196/63099, author="Tremblay, Dominique and Joly-Mischlich, Thomas and Dufour, Annick and Battista, Marie-Claude and Berbiche, Djamal and C{\^o}t{\'e}, Jos{\'e} and D{\'e}celles, Marco and Forget, Catherine and Gu{\'e}rin, Brigitte and Larivi{\`e}re, Manon and Lemay, Fr{\'e}d{\'e}ric and Lemonde, Manon and Maillet, {\'E}ric and Moreau, Nathalie and Pavic, Michel and Soldera, Sara and Wilhelmy, Catherine", title="Telehomecare Monitoring for Patients Receiving Anticancer Oral Therapy: Protocol for a Mixed Methods Evaluability Study", journal="JMIR Res Protoc", year="2025", month="Jan", day="20", volume="14", pages="e63099", keywords="telehealth", keywords="virtual care", keywords="telehomecare monitoring", keywords="anticancer oral therapy", keywords="oncology", keywords="electronic patient-reported outcomes", keywords="electronic patient-reported experience", keywords="evaluability study", keywords="mixed methods", keywords="implementation.", abstract="Background: Telehomecare monitoring (TM) in patients with cancer is a complex intervention. Research shows variations in the benefits and challenges TM brings to equitable access to care, the therapeutic relationship, self-management, and practice transformation. Further investigation into these variations factors will improve implementation processes and produce effective outcomes. Objective: This study aims to concurrently analyze implementation and evaluate the effectiveness of TM for patients receiving anticancer oral therapy. The objectives are to (1) contextualize how and why TM is implemented according to (a) site characteristics, (b) team characteristics, and (c) characteristics of patients receiving anticancer oral therapy; (2) assess TM effectiveness for recording electronic patient-reported outcome measures (ePROMs) and patient-reported experience measures (ePREMs) according to the site, implementation process, and patient characteristics; (3) describe the acceptability and feasibility of TM from the perspectives of the people directly or indirectly involved and provide evidence-based actionable guidance in anticipation of provincewide implementation. Methods: This type II hybrid effectiveness-implementation study uses a concurrent mixed methods design. Evaluability assessment is integrated into an emerging practice in 3 participating sites to enable the evaluation of implementation strategies on TM clinical outcomes. Quantitative data for ePROMs and ePREMs will be collected using validated oncology questionnaire. Descriptive statistics and repeated measures using multiple linear mixed models and generalized estimating equations analyses will be undertaken alongside interpretive descriptive coding of qualitative data. Qualitative data will be gathered from key informants guided by the RE-AIM (reach, efficacy, adoption, implementation, maintenance) framework and its extension, PRISM (practical robust implementation and sustainability model). The concurrent approach allows results at multiple stages of this study to be integrated iteratively. The methodological choice aims to provide real-world data that are rigorous, rapidly usable in practice, and transferable to other settings. Results: Questionnaires were pretested and the technological platform was codeveloped with members of the cancer care team and patients. Preparatory work was carried out to configure the TM platform and activate coordinating mechanisms between members of the cancer care team, patients, information technology experts, and the research team. A steering committee with 3 working groups was established to oversee the technological, clinical, and evaluation aspects of this study. Recruitment of patients for ePROMs started in February 2024, and data collection is expected to continue until March 2025. Interviews with members of the cancer care team began in November 2024. Full analysis should be completed by September 2025. Conclusions: This study will clarify how, why, for whom, and under what conditions TM can complement current care models. Our evaluability assessment will help to address implementation complexities and better understand intervention-to-practice operationalization so that implementation might be adapted to contextual factors without potentially harmful or inequitable impacts on patients. International Registered Report Identifier (IRRID): DERR1-10.2196/63099 ", doi="10.2196/63099", url="https://www.researchprotocols.org/2025/1/e63099" } @Article{info:doi/10.2196/66213, author="Kurdi, Feryal and Kurdi, Yahya and Reshetov, Vladimirovich Igor", title="Applications of Indocyanine Green in Breast Cancer for Sentinel Lymph Node Mapping: Protocol for a Scoping Review", journal="JMIRx Med", year="2025", month="Jan", day="6", volume="6", pages="e66213", keywords="indocyanine green", keywords="ICG", keywords="sentinel lymph node", keywords="breast cancer", keywords="fluorescence", keywords="axillary lymph node mapping", keywords="NIR", keywords="surgical planning", keywords="near-infrared", abstract="Introduction: Breast cancer is the leading cause of morbidity and mortality worldwide. Accurate sentinel lymph node (SLN) mapping is crucial for staging and treatment planning in early-stage breast cancer. Indocyanine green (ICG) has emerged as a promising agent for fluorescence imaging in SLN mapping. However, comprehensive assessment of its clinical utility, including accuracy and adverse effects, remains limited. This scoping review aims to consolidate evidence on the use of ICG in breast cancer SLN mapping. Objective: The objective of this scoping review is to evaluate the current literature on the use of ICG in SLN mapping for patients with breast cancer. This review aims to assess the accuracy, efficacy, and safety of ICG in this context and to identify gaps in the existing research. The outcomes will contribute to the development of further research as part of a PhD project. Methods: Five electronic databases will be searched (PubMed, Embase, MEDLINE, Web of Science, and Scopus) using search strategies developed in consultation with an academic supervisor. The search strategy is set to human studies published in English within the last 11 years. All retrieved citations will be imported to Zotero and then uploaded to Covidence for the screening of titles, abstracts, and full text according to prespecified inclusion criteria. Patients with early-stage breast cancer (T1 and T2), selected T3 cases where the SLN biopsy is accurate, and those with clinically node-negative breast cancer will be included. The intervention criterion includes studies using ICG for SLN mapping and studies on the assessment of fluorescence imaging cameras. Citations meeting the inclusion criteria for full-text review will have their data extracted by 2 independent reviewers, with disagreements resolved by discussion. A data extraction tool will be developed to capture full details about the participants, concept, and context, and findings relevant to the scoping review will be summarized. Results: The preliminary search began in December 2023. As of September 2024, papers have been screened and data are currently being extracted. Out of the 2130 references initially imported, 126 studies met the inclusion criteria after screening. The scoping review is expected to be published in January 2025. Conclusions: Although ICG technology has been used for SLN mapping in patients with breast cancer, initial searches in 2022 revealed limited data on this technique's feasibility, safety, and effectiveness. At that time, preliminary search of Scopus, MEDLINE, Embase, and PubMed identified no current or forthcoming systematic reviews or scoping reviews on the topic. However, recent searches indicate a substantial increase in research and reviews, reflecting a growing interest and evidence in this area. ", doi="10.2196/66213", url="https://xmed.jmir.org/2025/1/e66213" } @Article{info:doi/10.2196/64905, author="Normann, J. Amber and Mo, C. Clifton and Wilson, L. Rebekah and Perez, Michelle and Cutler, Corey and Uno, Hajime and Thompson, V. LaDora and Skinner, L. Tina and Richardson, G. Paul and Marinac, R. Catherine and Dieli-Conwright, M. Christina", title="Prehabilitation Exercise Training to Target Improved Muscle Strength in Pretransplant Patients Diagnosed With Multiple Myeloma: Protocol for a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Dec", day="19", volume="13", pages="e64905", keywords="multiple myeloma", keywords="stem cell transplantation", keywords="exercise training", keywords="aerobic exercise", keywords="resistance exercise", keywords="preoperative exercise", keywords="muscle strength", keywords="physical fitness", abstract="Background: Muscle mass and strength are severely compromised in patients diagnosed with multiple myeloma, such that the risk of poor overall survival increases as the prevalence of low muscle mass, also known as sarcopenia, increases. Additionally, at the time of autologous stem cell transplant (ASCT), 51\% of patients experience low muscle mass and strength, which can prolong hospitalization and lead to increased risk of obesity, insulin resistance, lowered physical function, and poor quality of life. Objective: The PROTECT (Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation) trial will examine the preliminary effects of digitally supervised prehabilitative aerobic and resistance exercise on muscle strength in patients with multiple myeloma scheduled for ASCT. Methods: This prospective, 2-armed single-center randomized controlled trial will recruit 30 patients with multiple myeloma, aged 18 years and older, planning to receive ASCT. Individuals will be assigned to either the exercise or the waitlist control group. The 8-week exercise intervention is home-based and digitally supervised by a clinical exercise trainer. The frequency of the exercise intervention is 3 times per week consisting of aerobic exercise on a cycle ergometer and resistance exercises, which are individually tailored based on patient health status. The waitlist control group maintains normal daily activities of living and is offered the intervention within 6 months from ASCT. The primary outcome is lower limb muscle strength, measured using the 10-repetition maximum leg press or extensor strength. Additional outcomes include physical and cardiorespiratory function, patient-reported outcomes, cardiometabolic health outcomes, and clinical outcomes. Results: The trial was funded in the fall of 2022 and recruitment began in June 2023. As of August 2024, a total of 3 participants have consented and been randomized (n=1, exercise group; n=2, waitlist control group). Trial completion and start of data analysis is expected in July 2025 with expected results to be published in early winter of 2026. Conclusions: We expect exercise to improve lower limb muscle strength and overall health outcomes compared to the waitlist control group. Results will contribute foundational knowledge needed to conduct larger-phase clinical trials testing the clinical benefits of prehabilitation exercise in this patient population. This study will provide insight into a prehabilitative exercise intervention designed to support patient prognosis. Trial Registration: ClinicalTrials.gov NCT05706766; https://clinicaltrials.gov/study/NCT05706766 International Registered Report Identifier (IRRID): DERR1-10.2196/64905 ", doi="10.2196/64905", url="https://www.researchprotocols.org/2024/1/e64905" } @Article{info:doi/10.2196/63155, author="Hermansen, Anna and Pollard, Samantha and McGrail, Kimberlyn and Bansback, Nick and Regier, A. Dean", title="Heuristics Identified in Health Data--Sharing Preferences of Patients With Cancer: Qualitative Focus Group Study", journal="J Med Internet Res", year="2024", month="Dec", day="17", volume="26", pages="e63155", keywords="heuristics", keywords="health data sharing", keywords="cancer patients", keywords="decision-making", keywords="real-world data", keywords="altruism", keywords="trust", keywords="control", keywords="data sharing", keywords="focus group", keywords="precision medicine", keywords="clinical data", keywords="exploratory study", keywords="qualitative", keywords="Canada", keywords="thematic analysis", keywords="informed consent", keywords="patient education", keywords="information technology", keywords="healthcare", keywords="medical informatics", abstract="Background: Evaluating precision oncology outcomes requires access to real-world and clinical trial data. Access is based on consent, and consent is based on patients' informed preferences when deciding to share their data. Decision-making is often modeled using utility theory, but a complex decision context calls for a consideration of how heuristic, intuitive thought processes interact with rational utility maximization. Data-sharing decision-making has been studied using heuristic theory, but almost no heuristic research exists in the health data context. This study explores this evidence gap, applying a qualitative approach to probe for evidence of heuristic mechanisms behind the health data-sharing preferences of those who have experienced cancer. Exploring qualitative decision-making reveals the types of heuristics used and how they are related to the process of decision-making to better understand whether consent mechanisms should consider nonrational processes to better serve patient decision-making. Objective: This study aimed to explore how patients with cancer use heuristics when deciding whether to share their data for research. Methods: The researchers conducted a focus group study of Canadians who have experienced cancer. We recruited participants through an online advertisement, screening individuals based on their ability to increase demographic diversity in the sample. We reviewed the literature on data-sharing platforms to develop a semistructured topic guide on concerns about data sharing, incentives to share, and consent and control. Focus group facilitators led the open-ended discussions about data-sharing preferences that revealed underlying heuristics. Two qualitative analysts coded transcripts using a heuristic framework developed from a review of the literature. Transcripts were analyzed for heuristic instances which were grouped according to sociocultural categories. Using thematic analysis, the analysts generated reflexive themes through norming sessions and consultations. Results: A total of 3 focus groups were held with 19 participants in total. The analysis identified 12 heuristics underlying intentions to share data. From the thematic analysis, we identified how the heuristics of social norms and community building were expressed through altruism; the recognition, reputation, and authority heuristics led to (dis)trust in certain institutions; the need for security prompted the illusion of control and transparency heuristics; and the availability and affect heuristics influenced attitudes around risk and benefit. These thematic relationships all had impacts on the participants' intentions to share their health data. Conclusions: The findings provide a novel qualitative understanding of how health data--sharing decisions and preferences may be based on heuristic processing. As patients consider the extent of risks and benefits, heuristic processes influence their assessment of anticipated outcomes, which may not result in rational, truly informed consent. This study shows how considering heuristic processing when designing current consent mechanisms opens up the opportunity for more meaningful and realistic interactions with the complex decision-making context. ", doi="10.2196/63155", url="https://www.jmir.org/2024/1/e63155" } @Article{info:doi/10.2196/63289, author="Carbunaru, Samuel and Neshatvar, Yassamin and Do, Hyungrok and Murray, Katie and Ranganath, Rajesh and Nayan, Madhur", title="Survival After Radical Cystectomy for Bladder Cancer: Development of a Fair Machine Learning Model", journal="JMIR Med Inform", year="2024", month="Dec", day="13", volume="12", pages="e63289", keywords="machine learning", keywords="bladder cancer", keywords="survival", keywords="prediction", keywords="model", keywords="bias", keywords="fairness", keywords="radical cystectomy", keywords="mortality rate", keywords="algorithmic fairness", keywords="health equity", keywords="healthcare disparities", abstract="Background: Prediction models based on machine learning (ML) methods are being increasingly developed and adopted in health care. However, these models may be prone to bias and considered unfair if they demonstrate variable performance in population subgroups. An unfair model is of particular concern in bladder cancer, where disparities have been identified in sex and racial subgroups. Objective: This study aims (1) to develop a ML model to predict survival after radical cystectomy for bladder cancer and evaluate for potential model bias in sex and racial subgroups; and (2) to compare algorithm unfairness mitigation techniques to improve model fairness. Methods: We trained and compared various ML classification algorithms to predict 5-year survival after radical cystectomy using the National Cancer Database. The primary model performance metric was the F1-score. The primary metric for model fairness was the equalized odds ratio (eOR). We compared 3 algorithm unfairness mitigation techniques to improve eOR. Results: We identified 16,481 patients; 23.1\% (n=3800) were female, and 91.5\% (n=15,080) were ``White,'' 5\% (n=832) were ``Black,'' 2.3\% (n=373) were ``Hispanic,'' and 1.2\% (n=196) were ``Asian.'' The 5-year mortality rate was 75\% (n=12,290). The best naive model was extreme gradient boosting (XGBoost), which had an F1-score of 0.860 and eOR of 0.619. All unfairness mitigation techniques increased the eOR, with correlation remover showing the highest increase and resulting in a final eOR of 0.750. This mitigated model had F1-scores of 0.86, 0.904, and 0.824 in the full, Black male, and Asian female test sets, respectively. Conclusions: The ML model predicting survival after radical cystectomy exhibited bias across sex and racial subgroups. By using algorithm unfairness mitigation techniques, we improved algorithmic fairness as measured by the eOR. Our study highlights the role of not only evaluating for model bias but also actively mitigating such disparities to ensure equitable health care delivery. We also deployed the first web-based fair ML model for predicting survival after radical cystectomy. ", doi="10.2196/63289", url="https://medinform.jmir.org/2024/1/e63289" } @Article{info:doi/10.2196/51877, author="Ma, Chunxuan and Adler, H. Rachel and Neidre, B. Daria and Chen, C. Ronald and Northouse, L. Laurel and Rini, Christine and Tan, Xianming and Song, Lixin", title="Challenges and Approaches to Recruitment for and Retention in a Dyad-Focused eHealth Intervention During COVID-19: Randomized Controlled Trial", journal="J Med Internet Res", year="2024", month="Dec", day="3", volume="26", pages="e51877", keywords="randomized controlled trials", keywords="RCT", keywords="prostate cancer", keywords="accrual", keywords="retention", keywords="COVID-19 pandemic", keywords="family-based research", abstract="Background: Family-based randomized controlled trials (RCTs) encounter recruitment and retention challenges. Cancer-focused RCTs typically recruit convenience samples from local cancer centers and hospitals. Objective: This study aimed to examine the recruitment and retention of a population-based, patient-partner dyad cohort in an RCT testing a dyadic eHealth intervention to improve the quality of life in patients with prostate cancer and their partners. Methods: In this 2-arm, parallel-group RCT, men who recently completed treatment for localized prostate cancer statewide were recruited through North Carolina Central Cancer Registry rapid case ascertainment between April 2018 and April 2021, coinciding with the COVID-19 pandemic. Patient-partner dyads underwent baseline assessments and were randomly assigned to either the intervention or control groups. Follow-up surveys were conducted at 4, 8, and 12 months after baseline. Descriptive and logistic regression analyses were used to achieve the study's aims. Results: Of the 3078 patients referred from rapid case ascertainment, 2899 were screened. A total of 357 partners were approached after obtaining the eligible patients' permission, 280 dyads completed baseline assessments and were randomized (dyad enrollment rate: 85.11\%, 95\% CI 81.3\%-88.9\%), and 221 dyads completed the 12-month follow-up (retention rate: 78.93\%, 95\% CI 74.2\%-83.7\%). Regarding the factors associated with retention, compared with White participants, people self-reporting as ``other races'' (including American Indian, Asian, and multiracial) were more likely to drop out of the study (odds ratio 2.78, 95\% CI 1.10-7.04), and older participants were less likely to withdraw (odds ratio 0.96, 95\% CI 0.92-0.99). Conclusions: Despite the negative impact of the pandemic, we successfully recruited enough patient-partner dyads to test our RCT hypotheses. Our recruitment and retention rates were equivalent to or higher than those in most dyadic intervention studies. A well-functioning research team and specific strategies (eg, eHealth intervention, internet phone, and online surveys) facilitated the recruitment and retention of patients with prostate cancer and their partners during the unprecedented pandemic. Trial Registration: ClinicalTrials.gov NCT03489057; https://clinicaltrials.gov/study/NCT03489057 International Registered Report Identifier (IRRID): RR2-https://doi.org/10.1186/s13063-021-05948-5 ", doi="10.2196/51877", url="https://www.jmir.org/2024/1/e51877", url="http://www.ncbi.nlm.nih.gov/pubmed/39625741" } @Article{info:doi/10.2196/59152, author="Hu, Chao and Fu, Qiang and Gao, Fei Fei and Zeng, Jian and Xiao, Wei and Li, Hui and Peng, Li and Huang, Xi and Yang, Li and Chen, Zhi Wen and Jiang, Yan Ming", title="Ultrasound-Guided High-Intensity Focused Ultrasound Combined With PD-1 Blockade in Patients With Liver Metastases From Lung Cancer: Protocol for a Single-Arm Phase 2 Trial", journal="JMIR Res Protoc", year="2024", month="Nov", day="29", volume="13", pages="e59152", keywords="high-intensity focused ultrasound", keywords="programmed cell death protein", keywords="PD-1 blockade", keywords="liver metastases", keywords="lung cancer", keywords="immunotherapy", keywords="treatment efficacy", keywords="quality of life", keywords="HILL study", abstract="Background: While immunotherapy has revolutionized oncological management, its efficacy in lung cancer patients with liver metastases remains limited, potentially due to the unique immunosuppressive microenvironment of the liver. Local liver treatment has been shown to enhance the immunotherapy response, and high-intensity focused ultrasound (HIFU), a minimally invasive local treatment, has demonstrated promising results in combination with immunotherapy. However, clinical data regarding HIFU in lung cancer with liver metastases are limited. Objective: We designed the HILL (Ultrasound-Guided High-Intensity Focused Ultrasound Combined With PD-1 Blockade in Patients With Liver Metastases From Lung Cancer) study to investigate the effectiveness and safety of HIFU in combination with immunotherapy for lung cancer with liver metastases. Methods: The HILL study is a single-armed, single-center, phase 2 clinical trial that will enroll 30 patients with lung cancer and liver metastases. The treatment regimen involves administering HIFU to liver metastases 1 week before the first dose of a programmed cell death protein (PD)--1 blockade, which is then administered every 3 weeks. The primary aim is to determine the overall response rate based on immune-related response criteria. Secondary aims include safety, progression-free survival, overall response, overall survival, and quality of life. Exploratory studies will also be conducted using whole blood, plasma, archival cancer tissue, and tumor biopsies during progression or relapse to identify potential biomarkers. Results: The study was funded on March 14, 2022, and received ethical approval on April 27, 2022. Clinical trial registration was completed by June 10, 2022, with participant recruitment beginning on July 10, 2022. Data collection commenced on July 14, 2022, with the enrollment of the first patient. By April 2024, 6 participants had been recruited. The results are expected to be published in December 2026. Conclusions: This study seeks to improve treatment outcomes for lung cancer patients with liver metastases by combining HIFU and PD-1 inhibition. The study also aims to identify potential biomarkers through exploratory research that can aid in selecting patients for optimized outcomes in the future. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200061076; https://www.chictr.org.cn/showproj.html?proj=170967 International Registered Report Identifier (IRRID): DERR1-10.2196/59152 ", doi="10.2196/59152", url="https://www.researchprotocols.org/2024/1/e59152" } @Article{info:doi/10.2196/64950, author="Gao, Zhiqiang and Teng, Jiajun and Qiao, Rong and Qian, Jialin and Pan, Feng and Ma, Meili and Lu, Jun and Zhang, Bo and Chu, Tianqing and Zhong, Hua", title="Efficacy and Safety of a Therapy Combining Sintilimab and Chemotherapy With Cryoablation in the First-Line Treatment of Advanced Nonsquamous Non--Small Cell Lung Cancer: Protocol for a Phase II, Pilot, Single-Arm, Single-Center Study", journal="JMIR Res Protoc", year="2024", month="Nov", day="8", volume="13", pages="e64950", keywords="cryoablation", keywords="immunotherapy", keywords="nonsquamous non--small cell lung cancer", abstract="Background: Immunotherapy has significantly advanced lung cancer treatment, particularly in nonsquamous non--small cell lung cancer (NSCLC), with overall response rates between 50\% and 60\%. However, about 30\% of patients only achieve a stable disease state. Cryoablation has shown potential to enhance immunotherapy by modifying the tumor's immune microenvironment through the release of antigens and immune factors. Addressing how to boost the immune response in these patients is critical. Objective: This study aims to investigate the efficacy and safety of immunochemotherapy in combination with cryoablation as a first-line treatment for advanced NSCLC. Methods: This is a phase II, pilot, open-label, single arm, single center, interventional study. Patients with stage IIIB to IIIC or IV NSCLC with T staging ranging from T1 to T2b will receive sintilimab (200 mg/m2 every 3 weeks) and chemotherapy. After 2 cycles, the feasibility of cryoablation will be considered for those with stable disease by a multidisciplinary team. Cryoablation with 3 freeze-thaw cycles will be performed for the main lesion. The third cycle of systemic therapy will begin 7 (SD 3) days after cryoablation. A total of 20 patients will be enrolled. Treatment will continue until the disease progresses, there is unacceptable toxicity, a participant withdraws consent, other discontinuation criteria are met, or the study reaches completion. The primary objective is to assess progression-free survival (PFS). The secondary objective is to assess efficacy through duration of response, disease control rate, overall survival (OS), and the safety profile. The exploratory objective is to investigate and compare immune factor changes after 2 cycles of immunochemotherapy and at 1, 3, and 7 days after cryoablation. Survival time will be estimated using the Kaplan-Meier method to calculate median PFS and OS. Any adverse events that occur during the trial will be promptly recorded. Results: The project was funded in 2024, and enrollment will be completed in 2025. The first results are expected to be submitted for publication in 2027. Conclusions: This study will provide evidence for the efficacy and safety of the combination of immunochemotherapy and cryoablation as a first-line treatment for advanced NSCLC. Although it has a limited sample size, the findings of this study will be used in the future to inform the design of a fully powered, 2-arm, larger-scale study. Trial Registration: ClinicalTrials.gov NCT06483009; https://clinicaltrials.gov/study/NCT06483009 International Registered Report Identifier (IRRID): PRR1-10.2196/64950 ", doi="10.2196/64950", url="https://www.researchprotocols.org/2024/1/e64950" } @Article{info:doi/10.2196/51936, author="Noggle, Brendan and Cheng, Hui and Sarkar, Mohamadi", title="Oral Cancer Incidence Among Adult Males With Current or Former Use of Cigarettes or Smokeless Tobacco: Population-Based Study", journal="JMIR Cancer", year="2024", month="Nov", day="6", volume="10", pages="e51936", keywords="tobacco harm reduction", keywords="oral cancer", keywords="smokeless tobacco", keywords="smoking", keywords="cancer epidemiology", keywords="cancer registry", keywords="population-based study", keywords="oral cancer incidence", keywords="cancer cases", abstract="Background: Tobacco use has been identified as a risk factor for oral cancer worldwide. However, relative oral cancer incidence among adults who smoke cigarettes, use smokeless tobacco products (ST), have transitioned from cigarettes to ST, quit cigarettes and/or ST (``quitters''), or never used tobacco has not been well studied. Objective: We aim to present population-based oral cancer incidence rates for adults who smoke cigarettes, use ST, are former smokers who now use ST, or quit. Methods: We estimated cross-sectional incidence rates and incidence rate ratios (IRRs) using data from statewide cancer registries (Colorado, Florida, North Carolina, and Texas) and population counts derived from national surveys using combined data from 2014?2017. A random-effect meta-analysis approach was used to summarize estimates among these groups, based on multiple imputation-based IRR estimates by state and age group while considering potential heterogeneity. Results: A total of 19,536 oral cancer cases were identified among adult males 35 years and older in the study geographies and period. The oral cancer incidence rate among adults who smoke was significantly higher than the ST group (2.6 times higher, 95\% CI 2.0?3.3, P<.001), 3.6 (95\% CI 3.2?4.1, P<.001) times higher than the never users, and 2.4 (95\% CI 1.8?3.1, P<.001) times higher compared to former smokers who now use ST. The IRR among the ST group relative to never users was 1.4 (95\% CI 1.1?1.9, P=.02). The IRR between former smokers who now use ST and those who quit was 1.4 (95\% CI 1.0?2.1, P=.08). Conclusions: Findings from this population-based study with a large number of oral cancer cases support significantly high oral cancer incidence among adults who smoke and a lower risk of oral cancer incidence among never users, quitters, users of ST, and former smokers who now use ST compared to cigarettes. Future studies with detailed control of tobacco history and other relevant confounders are needed to confirm these findings. ", doi="10.2196/51936", url="https://cancer.jmir.org/2024/1/e51936" } @Article{info:doi/10.2196/57199, author="Jafari, Mahtab and Shahverdian, Alex and Sadigh, Gelareh and Van Etten, A. Richard", title="Impact of Patient Personality on Adherence to Oral Anticancer Medications: An Opportunity?", journal="JMIR Cancer", year="2024", month="Oct", day="30", volume="10", pages="e57199", keywords="cancer", keywords="medication adherence", keywords="medication persistence", keywords="Five-Factor Model", keywords="Type D personality", keywords="oncology", keywords="cancer medications", keywords="oral anticancer therapy", keywords="chemotherapy", doi="10.2196/57199", url="https://cancer.jmir.org/2024/1/e57199" } @Article{info:doi/10.2196/50023, author="Renne, Lorenzo Salvatore and Cammelli, Manuela and Santori, Ilaria and Tassan-Mangina, Marta and Sam{\`a}, Laura and Ruspi, Laura and Sicoli, Federico and Colombo, Piergiuseppe and Terracciano, Maria Luigi and Quagliuolo, Vittorio and Cananzi, Maria Ferdinando Carlo", title="True Mitotic Count Prediction in Gastrointestinal Stromal Tumors: Bayesian Network Model and PROMETheus (Preoperative Mitosis Estimator Tool) Application Development", journal="J Med Internet Res", year="2024", month="Oct", day="22", volume="26", pages="e50023", keywords="GIST mitosis", keywords="risk classification", keywords="mHealth", keywords="mobile health", keywords="neoadjuvant therapy", keywords="patient stratification", keywords="Gastrointestinal Stroma", keywords="preoperative risk", abstract="Background: Gastrointestinal stromal tumors (GISTs) present a complex clinical landscape, where precise preoperative risk assessment plays a pivotal role in guiding therapeutic decisions. Conventional methods for evaluating mitotic count, such as biopsy-based assessments, encounter challenges stemming from tumor heterogeneity and sampling biases, thereby underscoring the urgent need for innovative approaches to enhance prognostic accuracy. Objective: The primary objective of this study was to develop a robust and reliable computational tool, PROMETheus (Preoperative Mitosis Estimator Tool), aimed at refining patient stratification through the precise estimation of mitotic count in GISTs. Methods: Using advanced Bayesian network methodologies, we constructed a directed acyclic graph (DAG) integrating pertinent clinicopathological variables essential for accurate mitotic count prediction on the surgical specimen. Key parameters identified and incorporated into the model encompassed tumor size, location, mitotic count from biopsy specimens, surface area evaluated during biopsy, and tumor response to therapy, when applicable. Rigorous testing procedures, including prior predictive simulations, validation utilizing synthetic data sets were employed. Finally, the model was trained on a comprehensive cohort of real-world GIST cases (n=80), drawn from the repository of the Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Humanitas Research Hospital, with a total of 160 cases analyzed. Results: Our computational model exhibited excellent diagnostic performance on synthetic data. Different model architecture were selected based on lower deviance and robust out-of-sample predictive capabilities. Posterior predictive checks (retrodiction) further corroborated the model's accuracy. Subsequently, PROMETheus was developed. This is an intuitive tool that dynamically computes predicted mitotic count and risk assessment on surgical specimens based on tumor-specific attributes, including size, location, surface area, and biopsy-derived mitotic count, using posterior probabilities derived from the model. Conclusions: The deployment of PROMETheus represents a potential advancement in preoperative risk stratification for GISTs, offering clinicians a precise and reliable means to anticipate mitotic counts on surgical specimens and a solid base to stratify patients for clinical studies. By facilitating tailored therapeutic strategies, this innovative tool is poised to revolutionize clinical decision-making paradigms, ultimately translating into improved patient outcomes and enhanced prognostic precision in the management of GISTs. ", doi="10.2196/50023", url="https://www.jmir.org/2024/1/e50023" } @Article{info:doi/10.2196/53825, author="Li, Mengdan and Yu, Zhifu and Li, Hui and Cao, Li and Yu, Huihui and Deng, Ning and Liu, Yunyong", title="Effects of Virtual Reality Therapy for Patients With Breast Cancer During Chemotherapy: Randomized Controlled Trial", journal="JMIR Serious Games", year="2024", month="Oct", day="17", volume="12", pages="e53825", keywords="virtual reality", keywords="breast neoplasms", keywords="quality of life", keywords="psychological distress", keywords="longitudinal studies", abstract="Background: Patients with breast cancer endure high levels of psychological and physical pain. Virtual reality (VR) may be an acceptable, safe intervention to alleviate the negative emotions and pain of patients with cancer. Objective: We aimed to test the long-term effects of VR on psychological distress and quality of life (QOL) with traditional care in Chinese patients with breast cancer. We also explored the intervention mechanism and the acceptability of VR. Methods: A total of 327 eligible participants were randomly assigned to a VR intervention group or a control group. The Distress Thermometer, QLQ-C30 (Quality of Life Questionnaire version 3.0), and Virtual Reality Symptom Questionnaire were assessed at baseline, postintervention (3 mo), and follow-up (6 mo). Analysis followed the intention-to-treat (ITT) principle. The generalized estimating equations model was used to analyze the longitudinal data, and the PROCESS macro was used to analyze the mediating effect. Results: Compared with the control group, patients with breast cancer in the VR group had lower distress scores (P=.007), and higher health-related QOL scores (physical, role, emotional, cognitive, and social functioning) after 6 months (P<.05). Psychological distress had mediating effects on the longitudinal association between VR and the health-related QOL (indirect effect=4.572?6.672, all P<.05). Conclusions: VR intervention technology may help reduce distress and improve QOL for patients with breast cancer over time. By incorporating a mediating analysis, we showed that the QOL benefits of VR intervention was manifested through positive effects on psychological distress risk factors. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000035049; https://www.chictr.org.cn/showproj.html?proj=53648 ", doi="10.2196/53825", url="https://games.jmir.org/2024/1/e53825" } @Article{info:doi/10.2196/55792, author="Ruela, Oliveira Ludmila and Moura, Castro Caroline de and Shieu, Bianca and Cho, Yu-Min and Yeh, Hsing Chao and Pimentel, Fernandes Franklin and Stefanello, Juliana", title="Auricular Therapy to Control Pain in Women With Breast Cancer: Protocol for Systematic Review and Meta-Analysis", journal="JMIR Res Protoc", year="2024", month="Oct", day="15", volume="13", pages="e55792", keywords="breast neoplasms", keywords="cancer pain", keywords="pain", keywords="auricular acupuncture", keywords="auricular therapy", keywords="systematic review", keywords="meta-analysis", abstract="Background: The increased incidence of breast cancer implies the appearance of frequent symptoms associated with disease and treatments, such as pain. For the management of this issue, auricular therapy has been used in a complementary manner, especially for its safety and analgesic action. Objective: This systematic review aims to summarize available evidence on the effects of auricular therapy on pain in women undergoing breast cancer treatment. Methods: This is a systematic review that includes randomized controlled trials that evaluated the effects of auricular therapy on pain in women with breast cancer, as compared with other interventions (sham or placebo auricular therapy, other nonpharmacological interventions, and routine pain treatments) during the treatment of the disease. Pain, whether induced or not by cancer treatments, is the main outcome to be evaluated. The search for the studies was performed in the following databases: MEDLINE through PubMed, CINAHL, CENTRAL, Embase, Web of Science, Scopus, VHL, TCIM Americas Network, CNKI, and Wanfang Data. The reviewers have independently evaluated the full texts, and in the near future, they will extract the data and assess the risk of bias in the included studies. The certainty of the evidence will be assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE), and a meta-analysis will be carried out to evaluate the intervention, considering the homogeneity of the results, using the Cochran Q test and quantified by the Higgins inconsistency index. The guidelines of the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) have been respected in the elaboration of this protocol. Results: The records screening stage has been completed, and the synthesis and meta-analysis were conducted in February 2024. We hope to have finished the preparation of the paper for publication by September 2024. Review reporting will follow standard guidelines for reporting systematic reviews. The results will be published in peer-reviewed scientific journals. Conclusions: This review will compile the strength of evidence for the use of auricular therapy in the management of pain in women with breast cancer during the treatment of the disease, identifying gaps in the available evidence as well as assisting health professionals in indicating the intervention for clinical practice. Trial Registration: PROSPERO CRD42022382433; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=382433 International Registered Report Identifier (IRRID): DERR1-10.2196/55792 ", doi="10.2196/55792", url="https://www.researchprotocols.org/2024/1/e55792" } @Article{info:doi/10.2196/52639, author="Hesso, Iman and Zacharias, Lithin and Kayyali, Reem and Charalambous, Andreas and Lavdaniti, Maria and Stalika, Evangelia and Ajami, Tarek and Acampa, Wanda and Boban, Jasmina and Nabhani-Gebara, Shereen", title="Artificial Intelligence for Optimizing Cancer Imaging: User Experience Study", journal="JMIR Cancer", year="2024", month="Oct", day="10", volume="10", pages="e52639", keywords="artificial intelligence", keywords="cancer", keywords="cancer imaging", keywords="UX design workshops", keywords="Delphi method", keywords="INCISIVE AI toolbox", keywords="user experience", abstract="Background: The need for increased clinical efficacy and efficiency has been the main force in developing artificial intelligence (AI) tools in medical imaging. The INCISIVE project is a European Union--funded initiative aiming to revolutionize cancer imaging methods using AI technology. It seeks to address limitations in imaging techniques by developing an AI-based toolbox that improves accuracy, specificity, sensitivity, interpretability, and cost-effectiveness. Objective: To ensure the successful implementation of the INCISIVE AI service, a study was conducted to understand the needs, challenges, and expectations of health care professionals (HCPs) regarding the proposed toolbox and any potential implementation barriers. Methods: A mixed methods study consisting of 2 phases was conducted. Phase 1 involved user experience (UX) design workshops with users of the INCISIVE AI toolbox. Phase 2 involved a Delphi study conducted through a series of sequential questionnaires. To recruit, a purposive sampling strategy based on the project's consortium network was used. In total, 16 HCPs from Serbia, Italy, Greece, Cyprus, Spain, and the United Kingdom participated in the UX design workshops and 12 completed the Delphi study. Descriptive statistics were performed using SPSS (IBM Corp), enabling the calculation of mean rank scores of the Delphi study's lists. The qualitative data collected via the UX design workshops was analyzed using NVivo (version 12; Lumivero) software. Results: The workshops facilitated brainstorming and identification of the INCISIVE AI toolbox's desired features and implementation barriers. Subsequently, the Delphi study was instrumental in ranking these features, showing a strong consensus among HCPs (W=0.741, P<.001). Additionally, this study also identified implementation barriers, revealing a strong consensus among HCPs (W=0.705, P<.001). Key findings indicated that the INCISIVE AI toolbox could assist in areas such as misdiagnosis, overdiagnosis, delays in diagnosis, detection of minor lesions, decision-making in disagreement, treatment allocation, disease prognosis, prediction, treatment response prediction, and care integration throughout the patient journey. Limited resources, lack of organizational and managerial support, and data entry variability were some of the identified barriers. HCPs also had an explicit interest in AI explainability, desiring feature relevance explanations or a combination of feature relevance and visual explanations within the toolbox. Conclusions: The results provide a thorough examination of the INCISIVE AI toolbox's design elements as required by the end users and potential barriers to its implementation, thus guiding the design and implementation of the INCISIVE technology. The outcome offers information about the degree of AI explainability required of the INCISIVE AI toolbox across the three services: (1) initial diagnosis; (2) disease staging, differentiation, and characterization; and (3) treatment and follow-up indicated for the toolbox. By considering the perspective of end users, INCISIVE aims to develop a solution that effectively meets their needs and drives adoption. ", doi="10.2196/52639", url="https://cancer.jmir.org/2024/1/e52639" } @Article{info:doi/10.2196/56851, author="Tao, Jin and Liu, Dan and Hu, Fu-Bi and Zhang, Xiao and Yin, Hongkun and Zhang, Huiling and Zhang, Kai and Huang, Zixing and Yang, Kun", title="Development and Validation of a Computed Tomography--Based Model for Noninvasive Prediction of the T Stage in Gastric Cancer: Multicenter Retrospective Study", journal="J Med Internet Res", year="2024", month="Oct", day="9", volume="26", pages="e56851", keywords="gastric cancer", keywords="computed tomography", keywords="radiomics", keywords="T stage", keywords="deep learning", keywords="cancer", keywords="multicenter study", keywords="accuracy", keywords="binary classification", keywords="tumor", keywords="hybrid model", keywords="performance", keywords="pathological stage", abstract="Background: As part of the TNM (tumor-node-metastasis) staging system, T staging based on tumor depth is crucial for developing treatment plans. Previous studies have constructed a deep learning model based on computed tomographic (CT) radiomic signatures to predict the number?of?lymph?node?metastases and survival in patients with resected gastric cancer (GC). However, few studies have reported the combination of deep learning and radiomics in predicting T staging in GC. Objective: This study aimed to develop a CT-based model for automatic prediction of the T stage of GC via radiomics and deep learning. Methods: A total of 771 GC patients from 3 centers were retrospectively enrolled and divided into training, validation, and testing cohorts. Patients with GC were classified into mild (stage T1 and T2), moderate (stage T3), and severe (stage T4) groups. Three predictive models based on the labeled CT images were constructed using the radiomics features (radiomics model), deep features (deep learning model), and a combination of both (hybrid model). Results: The overall classification accuracy of the radiomics model was 64.3\% in the internal testing data set. The deep learning model and hybrid model showed better performance than the radiomics model, with overall classification accuracies of 75.7\% (P=.04) and 81.4\% (P=.001), respectively. On the subtasks of binary classification of tumor severity, the areas under the curve of the radiomics, deep learning, and hybrid models were 0.875, 0.866, and 0.886 in the internal testing data set and 0.820, 0.818, and 0.972 in the external testing data set, respectively, for differentiating mild (stage T1{\textasciitilde}T2) from nonmild (stage T3{\textasciitilde}T4) patients, and were 0.815, 0.892, and 0.894 in the internal testing data set and 0.685, 0.808, and 0.897 in the external testing data set, respectively, for differentiating nonsevere (stage T1{\textasciitilde}T3) from severe (stage T4) patients. Conclusions: The hybrid model integrating radiomics features and deep features showed favorable performance in diagnosing the pathological stage of GC. ", doi="10.2196/56851", url="https://www.jmir.org/2024/1/e56851", url="http://www.ncbi.nlm.nih.gov/pubmed/39382960" } @Article{info:doi/10.2196/57183, author="Bertolaccini, Luca and Ciani, Oriana and Lucchi, Marco and Zaraca, Francesco and Bertani, Alessandro and Crisci, Roberto and Spaggiari, Lorenzo and ", title="Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT)", journal="JMIR Res Protoc", year="2024", month="Oct", day="8", volume="13", pages="e57183", keywords="lung cancer", keywords="quality of life", keywords="observational study", keywords="economic aspects", keywords="multicenter study", abstract="Background: Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitating an in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addresses this need by investigating the outcomes of patients with early and locally advanced lung cancer in Italy. Objective: With a focus on real-world data and patient registries, this study aims to provide comprehensive insights into clinical, psychosocial, and economic impacts, contributing to informed decision-making in health care. Methods: LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasive manual, robot-assisted, or traditional open surgery. The study will develop a web-based registry to collect longitudinal surgical, oncological, and socioeconomic outcome data. The primary objectives include performance assessment through the establishment of national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design ensures a diverse and representative study population. Results: The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzing real-world data, emphasizing the importance of patient-reported outcomes in enhancing the understanding of the disease. By developing a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations of traditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires. Recruitment will be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. The study will be completed in the year 2028. Conclusions: LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thorough evaluation of outcomes and care processes, guiding clinicians and policymakers in optimizing patient management. Furthermore, the study's secondary objectives, focusing on economic and psychosocial impacts, align with the contemporary emphasis on holistic cancer care. Insights gained from this study may influence treatment strategies, resource utilization, and patient well-being, thereby contributing to the ongoing refinement of lung cancer management. Trial Registration: ClinicalTrials.gov NCT05851755; https://clinicaltrials.gov/study/NCT05851755. ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140 International Registered Report Identifier (IRRID): PRR1-10.2196/57183 ", doi="10.2196/57183", url="https://www.researchprotocols.org/2024/1/e57183" } @Article{info:doi/10.2196/52985, author="Baum, Eleonore and Thiel, Christian and Kobleder, Andrea and Bernhardsgr{\"u}tter, Daniela and Engst, Ramona and Maurer, Carola and Koller, Antje", title="Using a Mobile Messenger Service as a Digital Diary to Capture Patients' Experiences Along Their Interorganizational Treatment Path in Gynecologic Oncology: Lessons Learned", journal="JMIR Cancer", year="2024", month="Jul", day="29", volume="10", pages="e52985", keywords="mobile apps", keywords="computer security", keywords="confidentiality", keywords="data collection", keywords="oncology", keywords="breast neoplasms", keywords="mobile phone", doi="10.2196/52985", url="https://cancer.jmir.org/2024/1/e52985", url="http://www.ncbi.nlm.nih.gov/pubmed/39073852" } @Article{info:doi/10.2196/56538, author="Raghu, Ananya and Raghu, Anisha and Wise, F. Jillian", title="Deep Learning--Based Identification of Tissue of Origin for Carcinomas of Unknown Primary Using MicroRNA Expression: Algorithm Development and Validation", journal="JMIR Bioinform Biotech", year="2024", month="Jul", day="24", volume="5", pages="e56538", keywords="cancer genomics", keywords="machine learning algorithms", keywords="deep learning", keywords="gene expression", keywords="RNA", keywords="RNAs", keywords="cancer", keywords="oncology", keywords="tumor", keywords="tumors", keywords="tissue", keywords="tissues", keywords="metastatic", keywords="microRNA", keywords="microRNAs", keywords="gene", keywords="genes", keywords="genomic", keywords="genomics", keywords="machine learning", keywords="algorithm", keywords="algorithms", keywords="carcinoma", keywords="genetics", keywords="genome", keywords="detection", keywords="bioinformatics", abstract="Background: Carcinoma of unknown primary (CUP) is a subset of metastatic cancers in which the primary tissue source of the cancer cells remains unidentified. CUP is the eighth most common malignancy worldwide, accounting for up to 5\% of all malignancies. Representing an exceptionally aggressive metastatic cancer, the median survival is approximately 3 to 6 months. The tissue in which cancer arises plays a key role in our understanding of sensitivities to various forms of cell death. Thus, the lack of knowledge on the tissue of origin (TOO) makes it difficult to devise tailored and effective treatments for patients with CUP. Developing quick and clinically implementable methods to identify the TOO of the primary site is crucial in treating patients with CUP. Noncoding RNAs may hold potential for origin identification and provide a robust route to clinical implementation due to their resistance against chemical degradation. Objective: This study aims to investigate the potential of microRNAs, a subset of noncoding RNAs, as highly accurate biomarkers for detecting the TOO through data-driven, machine learning approaches for metastatic cancers. Methods: We used microRNA expression data from The Cancer Genome Atlas data set and assessed various machine learning approaches, from simple classifiers to deep learning approaches. As a test of our classifiers, we evaluated the accuracy on a separate set of 194 primary tumor samples from the Sequence Read Archive. We used permutation feature importance to determine the potential microRNA biomarkers and assessed them with principal component analysis and t-distributed stochastic neighbor embedding visualizations. Results: Our results show that it is possible to design robust classifiers to detect the TOO for metastatic samples on The Cancer Genome Atlas data set, with an accuracy of up to 97\% (351/362), which may be used in situations of CUP. Our findings show that deep learning techniques enhance prediction accuracy. We progressed from an initial accuracy prediction of 62.5\% (226/362) with decision trees to 93.2\% (337/362) with logistic regression, finally achieving 97\% (351/362) accuracy using deep learning on metastatic samples. On the Sequence Read Archive validation set, a lower accuracy of 41.2\% (77/188) was achieved by the decision tree, while deep learning achieved a higher accuracy of 80.4\% (151/188). Notably, our feature importance analysis showed the top 3 most important features for predicting TOO to be microRNA-10b, microRNA-205, and microRNA-196b, which aligns with previous work. Conclusions: Our findings highlight the potential of using machine learning techniques to devise accurate tests for detecting TOO for CUP. Since microRNAs are carried throughout the body via extracellular vesicles secreted from cells, they may serve as key biomarkers for liquid biopsy due to their presence in blood plasma. Our work serves as a foundation toward developing blood-based cancer detection tests based on the presence of microRNA. ", doi="10.2196/56538", url="https://bioinform.jmir.org/2024/1/e56538", url="http://www.ncbi.nlm.nih.gov/pubmed/39046787" } @Article{info:doi/10.2196/50402, author="Cheng, Vienna and Sayre, C. Eric and Cheng, Vicki and Garg, Ria and Gill, Sharlene and Farooq, Ameer and De Vera, A. Mary", title="Patterns of Prescription Medication Use Before Diagnosis of Early Age-Onset Colorectal Cancer: Population-Based Descriptive Study", journal="JMIR Cancer", year="2024", month="Jul", day="12", volume="10", pages="e50402", keywords="colorectal cancer", keywords="medications", keywords="medication patterns", keywords="cancer diagnosis", keywords="prediagnosis", keywords="prescriptions", keywords="patterns", keywords="early-onset", keywords="population-based", keywords="incidence", keywords="male individuals", keywords="female individuals", keywords="health databases", keywords="pharmacology", keywords="diagnostic", keywords="descriptive study", keywords="gastroenterology", keywords="cancers", abstract="Background: Colorectal cancer (CRC) is estimated to be the fourth most common cancer diagnosis in Canada (except for nonmelanoma skin cancers) and the second and third leading cause of cancer-related death in male and female individuals, respectively. Objective: The rising incidence of early age-onset colorectal cancer (EAO-CRC; diagnosis at less than 50 years) calls for a better understanding of patients' pathway to diagnosis. Therefore, we evaluated patterns of prescription medication use before EAO-CRC diagnosis. Methods: We used linked administrative health databases in British Columbia (BC), Canada, to identify individuals diagnosed with EAO-CRC between January 1, 2010, and December 31, 2016 (hereinafter referred to as ``cases''), along with cancer-free controls (1:10), matched by age and sex. We identified all prescriptions dispensed from community pharmacies during the year prior to diagnosis and used the Anatomical Therapeutic Chemical Classification system Level 3 to group prescriptions according to the drug class. A parallel assessment was conducted for individuals diagnosed with average age-onset CRC (diagnosis at age 50 years and older). Results: We included 1001 EAO-CRC cases (n=450, 45\% female participants; mean 41.0, SD 6.1 years), and 12,989 prescriptions were filled in the year before diagnosis by 797 (79.7\%) individuals. Top-filled drugs were antidepressants (first; n=1698, 13.1\%). Drugs for peptic ulcer disease and gastroesophageal reflux disease (third; n=795, 6.1\%) were more likely filled by EAO-CRC cases than controls (odds ratio [OR] 1.4, 95\% CI 1.2-1.7) and with more frequent fills (OR 1.8, 95\% CI 1.7-1.9). We noted similar patterns for topical agents for hemorrhoids and anal fissures, which were more likely filled by EAO-CRC cases than controls (OR 7.4, 95\% CI 5.8-9.4) and with more frequent fills (OR 15.6, 95\% CI 13.1-18.6). Conclusions: We observed frequent prescription medication use in the year before diagnosis of EAO-CRC, including for drugs to treat commonly reported symptoms of EAO-CRC. ", doi="10.2196/50402", url="https://cancer.jmir.org/2024/1/e50402" } @Article{info:doi/10.2196/53354, author="Zheng, Yue and Zhao, Ailin and Yang, Yuqi and Wang, Laduona and Hu, Yifei and Luo, Ren and Wu, Yijun", title="Real-World Survival Comparisons Between Radiotherapy and Surgery for Metachronous Second Primary Lung Cancer and Predictions of Lung Cancer--Specific Outcomes Using Machine Learning: Population-Based Study", journal="JMIR Cancer", year="2024", month="Jun", day="12", volume="10", pages="e53354", keywords="metachronous second primary lung cancer", keywords="radiotherapy", keywords="surgical resection", keywords="propensity score matching analysis", keywords="machine learning", abstract="Background: Metachronous second primary lung cancer (MSPLC) is not that rare but is seldom studied. Objective: We aim to compare real-world survival outcomes between different surgery strategies and radiotherapy for MSPLC. Methods: This retrospective study analyzed data collected from patients with MSPLC between 1988 and 2012 in the Surveillance, Epidemiology, and End Results (SEER) database. Propensity score matching (PSM) analyses and machine learning were performed to compare variables between patients with MSPLC. Survival curves were plotted using the Kaplan-Meier method and were compared using log-rank tests. Results: A total of 2451 MSPLC patients were categorized into the following treatment groups: 864 (35.3\%) received radiotherapy, 759 (31\%) underwent surgery, 89 (3.6\%) had surgery plus radiotherapy, and 739 (30.2\%) had neither treatment. After PSM, 470 pairs each for radiotherapy and surgery were generated. The surgery group had significantly better survival than the radiotherapy group (P<.001) and the untreated group (563 pairs; P<.001). Further analysis revealed that both wedge resection (85 pairs; P=.004) and lobectomy (71 pairs; P=.002) outperformed radiotherapy in overall survival for MSPLC patients. Machine learning models (extreme gradient boosting, random forest classifier, adaptive boosting) demonstrated high predictive performance based on area under the curve (AUC) values. Least absolute shrinkage and selection operator (LASSO) regression analysis identified 9 significant variables impacting cancer-specific survival, emphasizing surgery's consistent influence across 1 year to 10 years. These variables encompassed age at diagnosis, sex, year of diagnosis, radiotherapy of initial primary lung cancer (IPLC), primary site, histology, surgery, chemotherapy, and radiotherapy of MPSLC. Competing risk analysis highlighted lower mortality for female MPSLC patients (hazard ratio [HR]=0.79, 95\% CI 0.71-0.87) and recent IPLC diagnoses (HR=0.79, 95\% CI 0.73-0.85), while radiotherapy for IPLC increased mortality (HR=1.31, 95\% CI 1.16-1.50). Surgery alone had the lowest cancer-specific mortality (HR=0.83, 95\% CI 0.81-0.85), with sublevel resection having the lowest mortality rate among the surgical approaches (HR=0.26, 95\% CI 0.21-0.31). The findings provide valuable insights into the factors that influence cumulative cancer-specific mortality. Conclusions: Surgical resections such as wedge resection and lobectomy confer better survival than radiation therapy for MSPLC, but radiation can be a valid alternative for the treatment of MSPLC. ", doi="10.2196/53354", url="https://cancer.jmir.org/2024/1/e53354", url="http://www.ncbi.nlm.nih.gov/pubmed/38865182" } @Article{info:doi/10.2196/54086, author="Jain, Rishabh and Kumar, Akash and Sharma, Atul and Sahoo, Kumar Ranjit and Sharma, Aparna and Seth, Amlesh and Nayak, Brusabhanu and Shamim, A. Shamim and Kaushal, Seema and KP, Haresh and Das, J. Chandan and Batra, Atul", title="Carboplatin in Patients With Metastatic Castration-Resistant Prostate Cancer Harboring Somatic or Germline Homologous Recombination Repair Gene Mutations: Phase II Single-Arm Trial", journal="JMIR Res Protoc", year="2024", month="Apr", day="18", volume="13", pages="e54086", keywords="carboplatin", keywords="mCRPC", keywords="prostate cancer", keywords="homologous recombinant gene repair", keywords="metastatic castration-resistant prostate cancer", keywords="incurable", keywords="deleterious mutation", keywords="synthetic lethality", keywords="tumor", keywords="DNA", keywords="low-income", keywords="middle-income", keywords="chemotherapeutic", keywords="drug", keywords="retrospective study", keywords="taxane", keywords="novel antiandrogen", keywords="single-arm study", keywords="health-related", keywords="quality of life", keywords="bone lesion", abstract="Background: Approximately 20\%-25\% of patients with metastatic castration-resistant prostate cancer (mCRPC) harbor a deleterious germline or somatic mutation in the homologous recombination repair (HRR) pathway genes, which is involved in the repair of double-stranded DNA damage. Half of these mutations are germline, while the remaining are exclusively somatic. While polyadenosine 5'diphosphoribose [poly (ADP-ribose)] polymerase inhibitors, such as olaparib and rucaparib, are effective in this subgroup, their widespread use is limited due to the associated high cost, especially in resource-constrained settings. Notably, platinum agents like carboplatin have exquisite sensitivity to cells with defective DNA repair machinery. Carboplatin, a conventional, inexpensive chemotherapeutic agent, offers a potential alternative treatment in such patients. Several retrospective small case series support this hypothesis. However, there are no prospective clinical trials of carboplatin in patients with mCRPC with HRR mutations. Objective: The primary objective is to assess the objective response rate of 3 weekly carboplatin treatments in patients with mCRPC harboring deleterious mutations in the HRR pathway genes and previously treated with a taxane or a novel antiandrogen agent. The secondary objectives include progression-free survival, health-related quality of life, and safety profile of carboplatin. Methods: Patients diagnosed with mCRPC harboring HRR pathway mutations previously treated with docetaxel or novel antiandrogen agents (abiraterone, enzalutamide, apalutamide, or darolutamide) or both will be eligible. Genes involved directly or indirectly in the HRR pathway will be tested. In this single-arm phase II study, we will screen approximately 200 patients to enroll 49 patients, and carboplatin (dosing at the area under curve=5) will be administered every 3 weeks until progression or intolerable side effects. The primary end point will be assessed as the proportion of patients with a reduction of serum prostate-specific antigen by more than 50\% from enrollment. Secondary outcomes include progression-free survival---soft-tissue disease progression (by response evaluation criteria in solid tumors, version 1.1, and bone lesion progression using Prostate Cancer Clinical Trials Working Group 3 criteria), health-related quality of life during carboplatin treatment using the Functional Assessment of Cancer Therapy---Prostate questionnaire and the European Organisation for Research and Treatment of Cancer questionnaire and safety profile of carboplatin (National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0). Results: The trial started enrollment in September 2023. This trial is ongoing, and 12 patients have been recruited to date. All 49 participants will be enrolled according to plan. Conclusions: This prospective phase II trial represents a critical step toward addressing the therapeutic gap in patients with mCRPC harboring HRR pathway mutations, particularly in demographic regions with limited access to poly (ADP-ribose) polymerase inhibitors. Outcomes from this study will inform clinical practice and guide future phase III randomized trials, ultimately improving patient outcomes globally. Trial Registration: Clinical Trials Registry of India CTRI/2023/04/051507; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Njc0NjU=\&Enc=\&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/54086 ", doi="10.2196/54086", url="https://www.researchprotocols.org/2024/1/e54086", url="http://www.ncbi.nlm.nih.gov/pubmed/38453159" } @Article{info:doi/10.2196/56658, author="Alhaj, Salah Shaikha and Qaderi, Abdulghaffar Fatma and Ibrahim, Tarek and Almohammad, Maha", title="Merkel Cell Carcinoma on the Face: Case Report", journal="JMIR Dermatol", year="2024", month="Apr", day="8", volume="7", pages="e56658", keywords="carcinoma", keywords="metastasis", keywords="lesion", keywords="biopsy", keywords="lesions", keywords="skin", keywords="Merkel", keywords="dermatology", keywords="nodules", keywords="cancer", keywords="oncology", keywords="lab", keywords="WBC: white blood cell", keywords="platelets", keywords="dermis", keywords="tumor", keywords="immunology", keywords="histology", keywords="histopathology", keywords="histopathological", keywords="immunological", keywords="immunohistochemistry", doi="10.2196/56658", url="https://derma.jmir.org/2024/1/e56658", url="http://www.ncbi.nlm.nih.gov/pubmed/38512218" } @Article{info:doi/10.2196/55723, author="Belfrage, Emma and Ek, Sara and Johansson, {\AA}sa and Brauner, Hanna and Sonesson, Andreas and Drott, Kristina", title="Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and S{\'e}zary Syndrome (BIO-MUSE): Protocol for a Translational Study", journal="JMIR Res Protoc", year="2024", month="Apr", day="4", volume="13", pages="e55723", keywords="mycosis fungoides", keywords="S{\'e}zary syndrome", keywords="prognostic", keywords="predictive", keywords="protocol", keywords="translational study", keywords="cutaneous T-cell lymphomas (CTCL)", keywords="skin microbiota", keywords="immunology", keywords="tissue microenvironment", keywords="epigenetics", keywords="quality of life", keywords="skin infection", keywords="Staphylococcus aureus", keywords="progression of disease", keywords="skin barrier", keywords="prognostic biomarkers", keywords="adult", keywords="adults", keywords="elderly", keywords="spatial", keywords="microbiological sampling", keywords="blood", keywords="study protocol", abstract="Background: Cutaneous T-cell lymphoma (CTCL) is a rare group of lymphomas that primarily affects the skin. Mycosis fungoides (MF) is the most common form of CTCL and S{\'e}zary syndrome (SS) is more infrequent. Early stages (IA-IIA) have a favorable prognosis, while advanced stages (IIB-IVB) have a worse prognosis. Around 25\% of patients with early stages of the disease will progress to advanced stages. Malignant skin-infiltrating T-cells in CTCL are accompanied by infiltrates of nonmalignant T-cells and other immune cells that produce cytokines that modulate the inflammation. Skin infection, often with Staphylococcus aureus, is frequent in advanced stages and can lead to sepsis and death. S. aureus has also been reported to contribute to the progression of the disease. Previous reports indicate a shift from Th1 to Th2 cytokine production and dysfunction of the skin barrier in CTCL. Treatment response is highly variable and often unpredictable, and there is a need for new predictive and prognostic biomarkers. Objective: This prospective translational study aims to identify prognostic biomarkers in the blood and skin of patients with MF and SS. Methods: The Predictive and Prognostic Biomarkers in Patients With MF and SS (BIO-MUSE) study aims to recruit 120 adult patients with MF or SS and a control group of 20 healthy volunteers. The treatments will be given according to clinical routine. The sampling of each patient will be performed every 3 months for 3 years. The blood samples will be analyzed for lactate dehydrogenase, immunoglobulin E, interleukins, thymus and activation-regulated chemokine, and lymphocyte subpopulations. The lymphoma microenvironment will be investigated through digital spatial profiling and single-cell RNA sequencing. Microbiological sampling and analysis of skin barrier function will be performed. The life quality parameters will be evaluated. The results will be evaluated by the stage of the disease. Results: Patient inclusion started in 2021 and is still ongoing in 2023, with 18 patients and 20 healthy controls enrolled. The publication of selected translational findings before the publication of the main results of the trial is accepted. Conclusions: This study aims to investigate blood and skin with a focus on immune cells and the microbiological environment to identify potential new prognostic biomarkers in MF and SS. Trial Registration: ClinicalTrials.gov NCT04904146; https://www.clinicaltrials.gov/study/NCT04904146 International Registered Report Identifier (IRRID): DERR1-10.2196/55723 ", doi="10.2196/55723", url="https://www.researchprotocols.org/2024/1/e55723", url="http://www.ncbi.nlm.nih.gov/pubmed/38436589" } @Article{info:doi/10.2196/55662, author="Wang, Kai-Hung and Shen, Hsuan-Shu and Chu, Sung-Chao and Wang, Tso-Fu and Lin, Ching-Wei and Huang, Wei-Han and Wu, Yi-Feng and Ho, Ching-Chun and Pang, Cheng-Yoong and Li, Chi-Cheng", title="Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial", journal="JMIR Res Protoc", year="2024", month="Mar", day="11", volume="13", pages="e55662", keywords="complementary treatment for cancer", keywords="neutropenia", keywords="real-world study", keywords="bedside to bench study", keywords="immune cell profile", keywords="programmed cell death protein 1", keywords="PD-1", keywords="breast cancer", keywords="breast", keywords="cancer", keywords="oncology", keywords="Chinese medicine", keywords="herb", keywords="herbs", keywords="herbal", keywords="complementary", keywords="immunity", keywords="immunology", keywords="immunomodulation", keywords="immunological", keywords="neutrophil", keywords="chemotherapy", keywords="blood cell", keywords="blood cells", abstract="Background: In recent years, advancements in cancer treatment have enabled cancer cell inhibition, leading to improved patient outcomes. However, the side effects of chemotherapy, especially leukopenia, impact patients' ability to tolerate their treatments and affect their quality of life. Traditional Chinese medicine is thought to provide complementary cancer treatment to improve the quality of life and prolong survival time among patients with cancer. Objective: This study aims to evaluate the effectiveness of Chinese herbal medicine (CHM) as a complementary treatment for neutropenia prevention and immunity modulation during chemotherapy in patients with breast cancer. Methods: We will conduct a real-world pragmatic clinical trial to evaluate the effectiveness of CHM as a supplementary therapy to prevent neutropenia in patients with breast cancer undergoing chemotherapy. Patients will be classified into CHM or non-CHM groups based on whether they received CHM during chemotherapy. Using generalized estimating equations or repeated measures ANOVA, we will assess differences in white blood cell counts, absolute neutrophil counts, immune cells, and programmed cell death protein 1 (PD-1) expression levels between the 2 groups. Results: This study was approved by the research ethics committee of Hualien Tzu Chi Hospital (IRB 110-168-A). The enrollment process began in September 2021 and will stop in December 2024. A total of 140 patients will be recruited. Data cleaning and analysis are expected to finish in the middle of 2025. Conclusions: Traditional Chinese medicine is the most commonly used complementary medicine, and it has been reported to significantly alleviate chemotherapy-related side effects. This study's findings may contribute to developing effective interventions targeting chemotherapy-related neutropenia among patients with breast cancer in clinical practice. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes International Registered Report Identifier (IRRID): DERR1-10.2196/55662 ", doi="10.2196/55662", url="https://www.researchprotocols.org/2024/1/e55662", url="http://www.ncbi.nlm.nih.gov/pubmed/38466979" } @Article{info:doi/10.2196/53627, author="Boehm, Dominik and Strantz, Cosima and Christoph, Jan and Busch, Hauke and Ganslandt, Thomas and Unberath, Philipp", title="Data Visualization Support for Tumor Boards and Clinical Oncology: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2024", month="Mar", day="5", volume="13", pages="e53627", keywords="clinical oncology", keywords="tumor board", keywords="cancer conference", keywords="multidisciplinary", keywords="visualization", keywords="software", keywords="tool", keywords="scoping review", keywords="tumor", keywords="malignant", keywords="benign", keywords="data sets", keywords="oncology", keywords="interactive visualization", keywords="data", keywords="patient", keywords="patients", keywords="physicians", keywords="medical practitioners", keywords="medical practitioner", keywords="conference", abstract="Background: Complex and expanding data sets in clinical oncology applications require flexible and interactive visualization of patient data to provide the maximum amount of information to physicians and other medical practitioners. Interdisciplinary tumor conferences in particular profit from customized tools to integrate, link, and visualize relevant data from all professions involved. Objective: The scoping review proposed in this protocol aims to identify and present currently available data visualization tools for tumor boards and related areas. The objective of the review will be to provide not only an overview of digital tools currently used in tumor board settings, but also the data included, the respective visualization solutions, and their integration into hospital processes. Methods: The planned scoping review process is based on the Arksey and O'Malley scoping study framework. The following electronic databases will be searched for articles published in English: PubMed, Web of Knowledge, and SCOPUS. Eligible articles will first undergo a deduplication step, followed by the screening of titles and abstracts. Second, a full-text screening will be used to reach the final decision about article selection. At least 2 reviewers will independently screen titles, abstracts, and full-text reports. Conflicting inclusion decisions will be resolved by a third reviewer. The remaining literature will be analyzed using a data extraction template proposed in this protocol. The template includes a variety of meta information as well as specific questions aiming to answer the research question: ``What are the key features of data visualization solutions used in molecular and organ tumor boards, and how are these elements integrated and used within the clinical setting?'' The findings will be compiled, charted, and presented as specified in the scoping study framework. Data for included tools may be supplemented with additional manual literature searches. The entire review process will be documented in alignment with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) flowchart. Results: The results of this scoping review will be reported per the expanded PRISMA-ScR guidelines. A preliminary search using PubMed, Web of Knowledge, and Scopus resulted in 1320 articles after deduplication that will be included in the further review process. We expect the results to be published during the second quarter of 2024. Conclusions: Visualization is a key process in leveraging a data set's potentially available information and enabling its use in an interdisciplinary setting. The scoping review described in this protocol aims to present the status quo of visualization solutions for tumor board and clinical oncology applications and their integration into hospital processes. International Registered Report Identifier (IRRID): DERR1-10.2196/53627 ", doi="10.2196/53627", url="https://www.researchprotocols.org/2024/1/e53627", url="http://www.ncbi.nlm.nih.gov/pubmed/38441925" } @Article{info:doi/10.2196/46625, author="Ow, Tsai-Wing and Sukocheva, Olga and Bampton, Peter and Iyngkaran, Guruparan and Rayner, K. Christopher and Tse, Edmund", title="Improving Concordance Between Clinicians With Australian Guidelines for Bowel Cancer Prevention Using a Digital Application: Randomized Controlled Crossover Study", journal="JMIR Cancer", year="2024", month="Feb", day="22", volume="10", pages="e46625", keywords="colorectal cancer", keywords="guidelines", keywords="colorectal cancer screening", keywords="digital application", keywords="questionnaire", keywords="application", keywords="cancer prevention", keywords="prevention", keywords="cancer", keywords="bowel cancer", keywords="surveillance", keywords="clinical vignette quiz", keywords="usability", keywords="Australia", abstract="Background: Australia's bowel cancer prevention guidelines, following a recent revision, are among the most complex in the world. Detailed decision tables outline screening or surveillance recommendations for 230 case scenarios alongside cessation recommendations for older patients. While these guidelines can help better allocate limited colonoscopy resources, their increasing complexity may limit their adoption and potential benefits. Therefore, tools to support clinicians in navigating these guidelines could be essential for national bowel cancer prevention efforts. Digital applications (DAs) represent a potentially inexpensive and scalable solution but are yet to be tested for this purpose. Objective: This study aims to assess whether a DA could increase clinician adherence to Australia's new colorectal cancer screening and surveillance guidelines and determine whether improved usability correlates with greater conformance to guidelines. Methods: As part of a randomized controlled crossover study, we created a clinical vignette quiz to evaluate the efficacy of a DA in comparison with the standard resource (SR) for making screening and surveillance decisions. Briefings were provided to study participants, which were tailored to their level of familiarity with the guidelines. We measured the adherence of clinicians according to their number of guideline-concordant responses to the scenarios in the quiz using either the DA or the SR. The maximum score was 18, with higher scores indicating improved adherence. We also tested the DA's usability using the System Usability Scale. Results: Of 117 participants, 80 were included in the final analysis. Using the SR, the adherence of participants was rated a median (IQR) score of 10 (7.75-13) out of 18. The participants' adherence improved by 40\% (relative risk 1.4, P<.001) when using the DA, reaching a median (IQR) score of 14 (12-17) out of 18. The DA was rated highly for usability with a median (IQR) score of 90 (72.5-95) and ranked in the 96th percentile of systems. There was a moderate correlation between the usability of the DA and better adherence (rs=0.4; P<.001). No differences between the adherence of specialists and nonspecialists were found, either with the SR (10 vs 9; P=.47) or with the DA (13 vs 15; P=.24). There was no significant association between participants who were less adherent with the DA (n=17) and their age (P=.06), experience with decision support tools (P=.51), or academic involvement with a university (P=.39). Conclusions: DAs can significantly improve the adoption of complex Australian bowel cancer prevention guidelines. As screening and surveillance guidelines become increasingly complex and personalized, these tools will be crucial to help clinicians accurately determine the most appropriate recommendations for their patients. Additional research to understand why some practitioners perform worse with DAs is required. Further improvements in application usability may optimize guideline concordance further. ", doi="10.2196/46625", url="https://cancer.jmir.org/2024/1/e46625", url="http://www.ncbi.nlm.nih.gov/pubmed/38238256" } @Article{info:doi/10.2196/50836, author="Liu, Chenan and Zhang, Qingsong and Liu, Chenning and Liu, Tong and Song, Mengmeng and Zhang, Qi and Xie, Hailun and Lin, Shiqi and Ren, Jiangshan and Chen, Yue and Zheng, Xin and Shi, Jinyu and Deng, Li and Shi, Hanping and Wu, Shouling", title="Age Differences in the Association of Sleep Duration Trajectory With Cancer Risk and Cancer-Specific Mortality: Prospective Cohort Study", journal="JMIR Public Health Surveill", year="2024", month="Feb", day="7", volume="10", pages="e50836", keywords="sleep duration", keywords="aging", keywords="cancer risk", keywords="mortality", keywords="sleep", keywords="trajectory", keywords="adult", abstract="Background: Baseline sleep duration is associated with cancer risk and cancer-specific mortality; however, the association between longitudinal patterns of sleep duration and these risks remains unknown. Objective: This study aimed to elucidate the association between sleep duration trajectory and cancer risk and cancer-specific mortality. Methods: The participants recruited in this study were from the Kailuan cohort, with all participants aged between 18 and 98 years and without cancer at baseline. The sleep duration of participants was continuously recorded in 2006, 2008, and 2010. Latent mixture modeling was used to identify shared sleep duration trajectories. Furthermore, the Cox proportional risk model was used to examine the association of sleep duration trajectory with cancer risk and cancer-specific mortality. Results: A total of 53,273 participants were included in the present study, of whom 40,909 (76.79\%) were men and 12,364 (23.21\%) were women. The average age of the participants was 49.03 (SD 11.76) years. During a median follow-up of 10.99 (IQR 10.27-11.15) years, 2705 participants developed cancers. Three sleep duration trajectories were identified: normal-stable (44,844/53,273, 84.18\%), median-stable (5877/53,273, 11.03\%), and decreasing low-stable (2552/53,273, 4.79\%). Compared with the normal-stable group, the decreasing low-stable group had increased cancer risk (hazard ratio [HR] 1.39, 95\% CI 1.16-1.65) and cancer-specific mortality (HR 1.54, 95\% CI 1.18-2.06). Dividing the participants by an age cutoff of 45 years revealed an increase in cancer risk (HR 1.88, 95\% CI 1.30-2.71) and cancer-specific mortality (HR 2.52, 95\% CI 1.22-5.19) only in participants younger than 45 years, rather than middle-aged or older participants. Joint analysis revealed that compared with participants who had a stable sleep duration within the normal range and did not snore, those with a shortened sleep duration and snoring had the highest cancer risk (HR 2.62, 95\% CI 1.46-4.70). Conclusions: Sleep duration trajectories and quality are closely associated with cancer risk and cancer-specific mortality. However, these associations differ with age and are more pronounced in individuals aged <45 years. Trial Registration: Chinese Clinical Trial Registry ChiCTR--TNRC--11001489; http://tinyurl.com/2u89hrhx ", doi="10.2196/50836", url="https://publichealth.jmir.org/2024/1/e50836", url="http://www.ncbi.nlm.nih.gov/pubmed/38324354" } @Article{info:doi/10.2196/49100, author="Oakley-Girvan, Ingrid and Yunis, Reem and Fonda, J. Stephanie and Longmire, Michelle and Veuthey, L. Tess and Shieh, Jennifer and Aghaee, Sara and Kubo, Ai and Davis, W. Sharon and Liu, Raymond and Neeman, Elad", title="Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study", journal="J Med Internet Res", year="2023", month="Nov", day="21", volume="25", pages="e49100", keywords="adverse events", keywords="cancer", keywords="decentralized clinical trials", keywords="electronic patient-reported outcomes", keywords="ePROs", keywords="mobile health app", keywords="observer-reported outcomes", keywords="Patient-Reported Outcomes Measurement Information System Patient-Reported Outcome Common Terminology Criteria for Adverse Events", keywords="patient-reported outcomes", keywords="PRO-CTCAE", keywords="PROMIS", keywords="remote clinical trials", keywords="remote monitoring", keywords="smartphone", abstract="Background: Timely collection of patient-reported outcomes (PROs) decreases emergency department visits and hospitalizations and increases survival. However, little is known about the outcome predictivity of unpaid informal caregivers' reporting using similar clinical outcome assessments. Objective: The aim of this study is to assess whether caregivers and adults with cancer adhered to a planned schedule for electronically collecting patient-reported outcomes (PROs) and if PROs were associated with future clinical events. Methods: We developed 2 iPhone apps to collect PROs, one for patients with cancer and another for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps independently for 4 weeks. Specific clinical events were obtained from the patients' electronic health records up to 6 months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events. Results: Participants completed 97\% (251/260) of the planned Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys and 98\% (254/260) of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with patients' hospitalizations or emergency department visits, grade 3-4 treatment-related adverse events, dose reductions (P<.05), and hospice referrals (P=.03). PROMIS surveys completed by caregivers were associated with hospice referrals (P=.02). PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality (P=.03), while their antecedent or final PROMIS surveys were associated with all clinical events examined except for total days of treatment breaks. Conclusions: In this study, caregivers and patients completed PROs using smartphone apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests that this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity. ", doi="10.2196/49100", url="https://www.jmir.org/2023/1/e49100", url="http://www.ncbi.nlm.nih.gov/pubmed/37988151" } @Article{info:doi/10.2196/48247, author="Han, Yongjun and Wei, Jiangpeng and Wang, Weidong and Gao, Ruiqi and Shen, Ning and Song, Xiaofeng and Ni, Yang and Li, Yulong and Xu, Li-Di and Chen, Weizhi and Li, Xiaohua", title="Multidimensional Analysis of a Cell-Free DNA Whole Methylome Sequencing Assay for Early Detection of Gastric Cancer: Protocol for an Observational Case-Control Study", journal="JMIR Res Protoc", year="2023", month="Sep", day="20", volume="12", pages="e48247", keywords="gastric cancer", keywords="circulating cell-free DNA", keywords="early detection", keywords="methylation", keywords="fragmentation", keywords="chromosomal instability", keywords="whole methylome sequencing", keywords="multidimensional model", abstract="Background: Commonly used noninvasive serological indicators serve as a step before endoscope diagnosis and help identify the high-risk gastric cancer (GC) population. However, they are associated with high false positives and high false negatives. Alternative noninvasive approaches, such as cancer-related features in cell-free DNA (cfDNA) fragments, have been gradually identified and play essential roles in early cancer detection. The integrated analysis of multiple cfDNA features has enhanced detection sensitivity compared to individual features. Objective: This study aimed to develop and validate an assay based on assessing genomic-scale methylation and fragmentation profiles of plasma cfDNA for early cancer detection, thereby facilitating the early diagnosis of GC. The primary objective is to evaluate the overall specificity and sensitivity of the assay in predicting GC within the entire cohort, and subsequently within each clinical stage of GC. The secondary objective involved investigating the specificity and sensitivity of the assay in combination with possible serological indicators. Methods: This is an observational case-control study. Blood samples will be prospectively collected before gastroscopy from 180 patients with GC and 180 nonmalignant control subjects (healthy or with benign gastric diseases). Cases and controls will be randomly divided into a training and a testing data set at a ratio of 2:1. Plasma cfDNA will be isolated and extracted, followed by bisulfite-free low-depth whole methylome sequencing. A multidimensional model named Thorough Epigenetic Marker Integration Solution (THEMIS) will be constructed in the training data set. The model includes features such as the methylated fragment ratio, chromosomal aneuploidy of featured fragments, fragment size index, and fragment end motif. The performance of the model in distinguishing between patients with cancer and noncancer controls will then be evaluated in the testing data set. Furthermore, GC-related biomarkers, such as pepsinogen, gastrin-17, and Helicobacter pylori, will be measured for each patient, and their predictive accuracy will be assessed both independently and in combination with the THEMIS model Results: Recruitment began in November 2022 and will be ended in April 2024. As of August 2022,250 patients have been enrolled. The final data analysis is anticipated to be completed by September 2024. Conclusions: This is the first registered case-control study designed to investigate a stacked ensemble model integrating several cfDNA features generated from a bisulfite-free whole methylome sequencing assay. These features include methylation patterns, fragmentation profiles, and chromosomal copy number changes, with the aim of identifying the GC population. This study will determine whether multidimensional analysis of cfDNA will prove to be an effective strategy for distinguishing patients with GC from nonmalignant individuals within the Chinese population. We anticipate the THEMIS model will complement the standard-of-care screening and aid in identifying high-risk patients for further diagnosis. Trial Registration: ClinicalTrial.gov NCT05668910; https://www.clinicaltrials.gov/study/NCT05668910 International Registered Report Identifier (IRRID): DERR1-10.2196/48247 ", doi="10.2196/48247", url="https://www.researchprotocols.org/2023/1/e48247", url="http://www.ncbi.nlm.nih.gov/pubmed/37728978" } @Article{info:doi/10.2196/51643, author="Lawton, Beverley and MacDonald, Jane Evelyn and Storey, Francesca and Stanton, Jo-Ann and Adcock, Anna and Gibson, Melanie and Parag, Varsha and Sparkes, Kereru Ngaire and Kaimoana, Bobby and King, Frances and Terry, Marion and Watson, Huti and Bennett, Matthew and Lambert, Seymour Charles and Geller, Stacie and Paasi, Isitokia and Hibma, Merilyn and Sykes, Peter and Hawkes, David and Saville, Marion", title="A Model for Empowering Rural Solutions for Cervical Cancer Prevention (He Tapu Te Whare Tangata): Protocol for a Cluster Randomized Crossover Trial", journal="JMIR Res Protoc", year="2023", month="Sep", day="14", volume="12", pages="e51643", keywords="uterine cervical neoplasms", keywords="cervical intraepithelial neoplasia", keywords="early detection of cancer", keywords="papillomavirus infections", keywords="New Zealand", keywords="self-testing", keywords="primary health care", keywords="Indigenous people", keywords="M?ori", keywords="point-of-care systems", keywords="colposcopy", keywords="health equity", abstract="Background: M?ori are the Indigenous people of Aotearoa (New Zealand). Despite global acceptance that cervical cancer is almost entirely preventable through vaccination and screening, w?hine M?ori (M?ori women) are more likely to have cervical cancer and 2.5 times more likely to die from it than non-M?ori women. Rural M?ori residents diagnosed with cervical cancer have worse outcomes than urban residents. Living in rural Aotearoa means experiencing barriers to appropriate and timely health care, resulting from distance, the lack of community resourcing, and low prioritization of rural needs by the health system and government. These barriers are compounded by the current screening processes and referral pathways that create delays at each step. Screening for high-risk human papillomavirus (hrHPV) and point-of-care (POC) testing are scientific advances used globally to prevent cervical cancer. Objective: This study aims to compare acceptability, feasibility, timeliness, referral to, and attendance for colposcopy following hrHPV detection between a community-controlled pathway and standard care. Methods: This is a cluster randomized crossover trial, with 2 primary care practices (study sites) as clusters. Each site was randomized to implement either pathway 1 or 2, with crossover occurring at 15 months. Pathway 1 (community-controlled pathway) comprises HPV self-testing, 1-hour POC results, face-to-face information, support, and immediate referral to colposcopy for women with a positive test result. Pathway 2 (standard care) comprises HPV self-testing, laboratory analysis, usual results giving, information, support, and standard referral pathways for women with a positive test result. The primary outcome is the proportion of women with hrHPV-positive results having a colposcopy within 20 working days of the HPV test (national performance indicator). Qualitative research will analyze successes and challenges of both pathways from the perspectives of governance groups, clinical staff, women, and their family. This information will directly inform the new National Cervical Screening Program. Results: In the first 15-month period, 743 eligible HPV self-tests were performed: 370 in pathway 1 with POC testing and 373 in pathway 2 with laboratory testing. The positivity rate for hrHPV was 7.3\% (54/743). Data collection for the second period, qualitative interviews, and analyses are ongoing. Conclusions: This M?ori-centered study combines quantitative and qualitative research to compare 2 clinical pathways from detection of hrHPV to colposcopy. This protocol draws on rural community practices strengths, successfully engaging M?ori from a wh?nau ora (family wellness) approach including kanohi ki te kanohi (face-to-face), kai?whina (nonclinical community health workers), and multiple venues for interventions. It will inform the theory and practice of rural models of the use of innovative technology, addressing M?ori cervical cancer inequities and facilitating M?ori wellness. The findings are anticipated to be applicable to other Indigenous and rural people in high-income countries. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000553875; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000553875 International Registered Report Identifier (IRRID): DERR1-10.2196/51643 ", doi="10.2196/51643", url="https://www.researchprotocols.org/2023/1/e51643", url="http://www.ncbi.nlm.nih.gov/pubmed/37707939" } @Article{info:doi/10.2196/41999, author="Qiu, Hang and Wang, Liya and Zhou, Li and Wang, Xiaodong", title="Comorbidity Patterns in Patients Newly Diagnosed With Colorectal Cancer: Network-Based Study", journal="JMIR Public Health Surveill", year="2023", month="Sep", day="5", volume="9", pages="e41999", keywords="colorectal cancer", keywords="comorbidity patterns", keywords="prevalence", keywords="health status disparities", keywords="network analysis", keywords="routinely collected health data", abstract="Background: Patients with colorectal cancer (CRC) often present with multiple comorbidities, and many of these can affect treatment and survival. However, previous comorbidity studies primarily focused on diseases in commonly used comorbidity indices. The comorbid status of CRC patients with respect to the entire spectrum of chronic diseases has not yet been investigated. Objective: This study aimed to systematically analyze all chronic diagnoses and diseases co-occurring, using a network-based approach and large-scale administrative health data, and provide a complete picture of the comorbidity pattern in patients newly diagnosed with CRC from southwest China. Methods: In this retrospective observational study, the hospital discharge records of 678 hospitals from 2015 to 2020 in Sichuan Province, China were used to identify new CRC cases in 2020 and their history of diseases. We examined all chronic diagnoses using ICD-10 (International Classification of Diseases, 10th Revision) codes at 3 digits and focused on chronic diseases with >1\% prevalence in at least one subgroup (1-sided test, P<.025), which resulted in a total of 66 chronic diseases. Phenotypic comorbidity networks were constructed across all CRC patients and different subgroups by sex, age (18-59, 60-69, 70-79, and ?80 years), area (urban and rural), and cancer site (colon and rectum), with comorbidity as a node and linkages representing significant correlations between multiple comorbidities. Results: A total of 29,610 new CRC cases occurred in Sichuan, China in 2020. The mean patient age at diagnosis was 65.6 (SD 12.9) years, and 75.5\% (22,369/29,610) had at least one comorbidity. The most prevalent comorbidities were hypertension (8581/29,610, 29.0\%; 95\% CI 28.5\%-29.5\%), hyperplasia of the prostate (3816/17,426, 21.9\%; 95\% CI 21.3\%-22.5\%), and chronic obstructive pulmonary disease (COPD; 4199/29,610, 14.2\%; 95\% CI 13.8\%-14.6\%). The prevalence of single comorbidities was different in each subgroup in most cases. Comorbidities were closely associated, with disorders of lipoprotein metabolism and hyperplasia of the prostate mediating correlations between other comorbidities. Males and females shared 58.3\% (141/242) of disease pairs, whereas male-female disparities occurred primarily in diseases coexisting with COPD, cerebrovascular diseases, atherosclerosis, heart failure, or renal failure among males and with osteoporosis or gonarthrosis among females. Urban patients generally had more comorbidities with higher prevalence and more complex disease coexistence relationships, whereas rural patients were more likely to have co-existing severe diseases, such as heart failure comorbid with the sequelae of cerebrovascular disease or COPD. Conclusions: Male-female and urban-rural disparities in the prevalence of single comorbidities and their complex coexistence relationships in new CRC cases were not due to simple coincidence. The results reflect clinical practice in CRC patients and emphasize the importance of measuring comorbidity patterns in terms of individual and coexisting diseases in order to better understand comorbidity patterns. ", doi="10.2196/41999", url="https://publichealth.jmir.org/2023/1/e41999", url="http://www.ncbi.nlm.nih.gov/pubmed/37669093" } @Article{info:doi/10.2196/44264, author="Hussain, Yaqza and Bannaga, Ayman and Fisher, Neil and Krishnamoorthy, Ashwin and Kimani, Peter and Malik, Ahmad and Truslove, Maria and Joshi, Shivam and Hitchins, Megan and Abbasi, Abdullah and Corbett, Christopher and Brookes, Matthew and Randeva, Harpal and Than, Ni Nwe and Arasaradnam, P. Ramesh", title="The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study", journal="JMIR Res Protoc", year="2023", month="May", day="31", volume="12", pages="e44264", keywords="hepatocellular cancer", keywords="cirrhosis", keywords="methylated septin 9", keywords="urinary volatile organic compounds", keywords="urinary peptides", keywords="fatty liver", keywords="fatty liver disease", keywords="hepatitis", keywords="liver cancer", abstract="Background: Hepatocellular cancer (HCC) is associated with high mortality, and early diagnosis leads to better survival. Patients with cirrhosis, especially due to nonalcoholic fatty liver disease and viral hepatitis, are at higher risk of developing HCC and form the main screening group. The current screening methods for HCC (6-monthly screening with serum alpha fetoprotein and ultrasound liver) have low sensitivity; hence, there is a need for better screening markers for HCC. Objective: Our study, TENDENCY, aims to validate the novel screening markers (methylated septin 9, urinary volatile organic compounds, and urinary peptides) for HCC diagnosis and study these noninvasive biomarkers in liver disease. Methods: This is a multicenter, nested case-control study, which involves comparing the plasma levels of methylated septin 9 between confirmed HCC cases and patients with cirrhosis (control group). It also includes the comparison of urine samples for the detection of HCC-specific volatile organic compounds and peptides. Based on the findings of a pilot study carried out at University Hospital Coventry \& Warwickshire, we estimated our sample size to be 308 (n=88, 29\% patients with HCC; n=220, 71\% patients with cirrhosis). Urine and plasma samples will be collected from all participants and will be frozen at --80 {\textdegree}C until the end of recruitment. Gas chromatography--mass spectrometry will be used for urinary volatile organic compounds detection, and capillary electrophoresis--mass spectrometry will be used for urinary peptide identification. Real-time polymerase chain reaction will be used for the qualitative detection of plasma methylated septin 9. The study will be monitored by the Research and Development department at University Hospital Coventry \& Warwickshire. Results: The recruitment stage was completed in March 2023. The TENDENCY study is currently in the analysis stage, which is expected to finish by November 2023. Conclusions: There is lack of effective screening tests for hepatocellular cancer despite higher mortality rates. The application of more sensitive plasma and urinary biomarkers for hepatocellular cancer screening in clinical practice will allow us to detect the disease at earlier stages and hence, overall, improve HCC outcomes. International Registered Report Identifier (IRRID): DERR1-10.2196/44264 ", doi="10.2196/44264", url="https://www.researchprotocols.org/2023/1/e44264", url="http://www.ncbi.nlm.nih.gov/pubmed/37256650" } @Article{info:doi/10.2196/38167, author="Constance, E. Jonathan and McFarland, M. Mary and Casucci, Tallie and Deininger, W. Michael and Enioutina, Y. Elena and Job, Kathleen and Lemons, S. Richard and Lim, S. Carol and Ward, M. Robert and Yellepeddi, Venkata and Watt, M. Kevin", title="Mapping the Evidence for Opioid-Mediated Changes in Malignancy and Chemotherapeutic Efficacy: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2023", month="May", day="22", volume="12", pages="e38167", keywords="opioid", keywords="opioid receptor", keywords="drug", keywords="cocaine", keywords="crack", keywords="prescription opioid", keywords="opium", keywords="war on drug", keywords="cancer", keywords="chemotherapy", keywords="drug-drug interaction", keywords="malignancy", keywords="treatment", keywords="oncology", keywords="tumor", keywords="survival", keywords="antineoplastic", keywords="cancer cell", keywords="scoping", keywords="chemotherapeutic", keywords="librarian", keywords="library science", keywords="antineoplast", keywords="cancer cell survival", keywords="cancer cell growth", keywords="addict", keywords="addiction", abstract="Background: Numerous reports contend opioids can augment or inhibit malignancy. At present, there is no consensus on the risk or benefit posed by opioids on malignancy or chemotherapeutic activity. Distinguishing the consequences of opioid use from pain and its management is challenging. Additionally, opioid concentration data is often lacking in clinical studies. A scoping review approach inclusive of preclinical and clinical data will improve our understanding of the risk-benefit relationship concerning commonly prescribed opioids and cancer and cancer treatment. Objective: The aim of the study is to map diverse studies spanning from preclinical to clinical regarding opioids with malignancy and its treatment. Methods: This scoping review will use the Arksey six stages framework to (1) identify the research question; (2) identify relevant studies; (3) select studies meeting criteria; (4) extract and chart data; (5) collate, summarize, and report results; and (6) conduct expert consultation. An initial pilot study was undertaken to (1) parameterize the extent and scale of existing data for an evidence review, (2) identify key factors to be extracted in systematic charting efforts, and (3) assess opioid concentration as a variable for its relevance to the central hypothesis. Six databases will be searched with no filters: MEDLINE, Embase, CINAHL Complete, Cochrane Library, Biological Sciences Collection, and International Pharmaceutical Abstracts. Trial registries will include ClinicalTrials.gov, Cochrane CENTRAL, International Standard Randomised Controlled Trial Number Registry, European Union Clinical Trials Register, and World Health Organization International Clinical Trials Registry. Eligibility criteria will include preclinical and clinical study data on opioids effects on tumor growth or survival, or alteration on the antineoplastic activity of chemotherapeutics. We will chart data on (1) opioid concentration from human subjects with cancer, yielding a ``physiologic range'' to better interpret available preclinical data; (2) patterns of opioid exposure with disease and treatment-related patient outcomes; and (3) the influence of opioids on cancer cell survival, as well as opioid-related changes to cancer cell susceptibility for chemotherapeutics. Results: This scoping review will present results in narrative forms as well as with the use of tables and diagrams. Initiated in February 2021 at the University of Utah, this protocol is anticipated to generate a scoping review by August 2023. The results of the scoping review will be disseminated through scientific conference proceedings and presentations, stakeholder meetings, and by publication in a peer-reviewed journal. Conclusions: The findings of this scoping review will provide a comprehensive description of the consequences of prescription opioids on malignancy and its treatment. By incorporating preclinical and clinical data, this scoping review will invite novel comparisons across study types that could inform new basic, translational, and clinical studies regarding risks and benefits of opioid use among patients with cancer. International Registered Report Identifier (IRRID): PRR1-10.2196/38167 ", doi="10.2196/38167", url="https://www.researchprotocols.org/2023/1/e38167", url="http://www.ncbi.nlm.nih.gov/pubmed/37213193" } @Article{info:doi/10.2196/44695, author="Florensa, Didac and Mateo-Fornes, Jordi and Lopez Sorribes, Sergi and Torres Tuca, Anna and Solsona, Francesc and Godoy, Pere", title="Exploring Cancer Incidence, Risk Factors, and Mortality in the Lleida Region: Interactive, Open-source R Shiny Application for Cancer Data Analysis", journal="JMIR Cancer", year="2023", month="Apr", day="20", volume="9", pages="e44695", keywords="R Shiny", keywords="cloud computing", keywords="microservices", keywords="Docker", keywords="decision support system", keywords="cancer incidence", keywords="cancer risk factors, cancer mortality", abstract="Background: The cancer incidence rate is essential to public health surveillance. The analysis of this information allows authorities to know the cancer situation in their regions, especially to determine cancer patterns, monitor cancer trends, and help prioritize the allocation of health resource. Objective: This study aimed to present the design and implementation of an R Shiny application to assist cancer registries conduct rapid descriptive and predictive analytics in a user-friendly, intuitive, portable, and scalable way. Moreover, we wanted to describe the design and implementation road map to inspire other population registries to exploit their data sets and develop similar tools and models. Methods: The first step was to consolidate the data into the population registry cancer database. These data were cross validated by ASEDAT software, checked later, and reviewed by experts. Next, we developed an online tool to visualize the data and generate reports to assist decision-making under the R Shiny framework. Currently, the application can generate descriptive analytics using population variables, such as age, sex, and cancer type; cancer incidence in region-level geographical heat maps; line plots to visualize temporal trends; and typical risk factor plots. The application also showed descriptive plots about cancer mortality in the Lleida region. This web platform was built as a microservices cloud platform. The web back end consists of an application programming interface and a database, which NodeJS and MongoDB have implemented. All these parts were encapsulated and deployed by Docker and Docker Compose. Results: The results provide a successful case study in which the tool was applied to the cancer registry of the Lleida region. The study illustrates how researchers and cancer registries can use the application to analyze cancer databases. Furthermore, the results highlight the analytics related to risk factors, second tumors, and cancer mortality. The application shows the incidence and evolution of each cancer during a specific period for gender, age groups, and cancer location, among other functionalities. The risk factors view permitted us to detect that approximately 60\% of cancer patients were diagnosed with excess weight at diagnosis. Regarding mortality, the application showed that lung cancer registered the highest number of deaths for both genders. Breast cancer was the lethal cancer in women. Finally, a customization guide was included as a result of this implementation to deploy the architecture presented. Conclusions: This paper aimed to document a successful methodology for exploiting the data in population cancer registries and propose guidelines for other similar records to develop similar tools. We intend to inspire other entities to build an application that can help decision-making and make data more accessible and transparent for the community of users. ", doi="10.2196/44695", url="https://cancer.jmir.org/2023/1/e44695", url="http://www.ncbi.nlm.nih.gov/pubmed/37079353" } @Article{info:doi/10.2196/39740, author="Wilson, Rebekah and Kang, Dong-Woo and Tahbaz, Meghan and Norris, Mary and Uno, Hajime and Ligibel, Jennifer and Guenette, Jeffrey and Christopher, Cameron and Dieli-Conwright, Christina", title="Improving Cognitive Function Through High-Intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Apr", day="7", volume="12", pages="e39740", keywords="cognitive function", keywords="high-intensity interval training", keywords="exercise", keywords="breast cancer", keywords="chemotherapy", keywords="magnetic resonance imaging", keywords="MRI", abstract="Background: More than 75\% of patients with breast cancer treated with chemotherapy experience cognitive impairments (eg, memory and attention problems), commonly known as chemo-brain. Exercise, especially aerobic high-intensity interval training (HIIT), is associated with better cognitive function in healthy populations. However, clinical trials testing the impact of exercise interventions on chemotherapy-induced cognitive decline in patients with cancer are lacking, and the mechanisms through which exercise could improve cognitive function are unclear. Objective: The objective of the Improving Cognitive Function Through High-Intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy trial is to examine the effects of HIIT on cognitive function in patients with breast cancer undergoing chemotherapy. Methods: This 2-arm, single-center, pilot randomized controlled trial will randomize 50 patients with breast cancer undergoing chemotherapy to HIIT or attention control. The HIIT group will perform a supervised 16-week, thrice-weekly intervention, with each session including a 5-minute warm-up at 10\% maximal power output (POmax), 10 sets of alternating 1-minute high-intensity (90\% POmax) and 1-minute recovery (10\% POmax) intervals, and a 5-minute cooldown (10\% POmax). The attention control group will receive a stretching program with no exercise components and be asked to maintain their exercise levels for 16 weeks. The primary outcomes of the study are executive function and memory measured using the National Institutes of Health toolbox and resting-state connectivity and diffusion tensor imaging microstructure evaluated using magnetic resonance imaging. The secondary and tertiary outcomes include cardiorespiratory fitness, body composition, physical fitness, and psychosocial health. The study has been approved by the institutional review board of the Dana-Farber Cancer Institute (20-222). Results: The trial was funded in January 2019, with recruitment started in June 2021. As of May 2022, a total of 4 patients have consented and been randomized (n=2, 50\% to exercise; n=1, 25\% to control; and n=1, 25\% nonrandomized). Trial completion is expected in January 2024. Conclusions: This first-of-its-kind study incorporates a novel exercise intervention (ie, HIIT) and comprehensive cognitive measures. If positive, our findings will establish the pilot efficacy of HIIT on chemotherapy-induced cognitive function in patients with breast cancer, providing the foundation for future larger phase-II and phase-III trials to confirm the findings and potentially establish HIIT as a standard of care for women undergoing chemotherapy for breast cancer. Trial Registration: ClinicalTrials.gov NCT04724499; https://clinicaltrials.gov/ct2/show/NCT04724499 International Registered Report Identifier (IRRID): DERR1-10.2196/39740 ", doi="10.2196/39740", url="https://www.researchprotocols.org/2023/1/e39740", url="http://www.ncbi.nlm.nih.gov/pubmed/37027186" } @Article{info:doi/10.2196/44248, author="Jan, Zainab and El Assadi, Farah and Abd-alrazaq, Alaa and Jithesh, Veettil Puthen", title="Artificial Intelligence for the Prediction and Early Diagnosis of Pancreatic Cancer: Scoping Review", journal="J Med Internet Res", year="2023", month="Mar", day="31", volume="25", pages="e44248", keywords="artificial Intelligence", keywords="pancreatic cancer", keywords="diagnosis", keywords="diagnostic", keywords="prediction", keywords="machine learning", keywords="deep learning", keywords="scoping", keywords="review method", keywords="predict", keywords="cancer", keywords="oncology", keywords="pancreatic", keywords="algorithm", abstract="Background: Pancreatic cancer is the 12th most common cancer worldwide, with an overall survival rate of 4.9\%. Early diagnosis of pancreatic cancer is essential for timely treatment and survival. Artificial intelligence (AI) provides advanced models and algorithms for better diagnosis of pancreatic cancer. Objective: This study aims to explore AI models used for the prediction and early diagnosis of pancreatic cancers as reported in the literature. Methods: A scoping review was conducted and reported in line with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. PubMed, Google Scholar, Science Direct, BioRXiv, and MedRxiv were explored to identify relevant articles. Study selection and data extraction were independently conducted by 2 reviewers. Data extracted from the included studies were synthesized narratively. Results: Of the 1185 publications, 30 studies were included in the scoping review. The included articles reported the use of AI for 6 different purposes. Of these included articles, AI techniques were mostly used for the diagnosis of pancreatic cancer (14/30, 47\%). Radiological images (14/30, 47\%) were the most frequently used data in the included articles. Most of the included articles used data sets with a size of <1000 samples (11/30, 37\%). Deep learning models were the most prominent branch of AI used for pancreatic cancer diagnosis in the studies, and the convolutional neural network was the most used algorithm (18/30, 60\%). Six validation approaches were used in the included studies, of which the most frequently used approaches were k-fold cross-validation (10/30, 33\%) and external validation (10/30, 33\%). A higher level of accuracy (99\%) was found in studies that used support vector machine, decision trees, and k-means clustering algorithms. Conclusions: This review presents an overview of studies based on AI models and algorithms used to predict and diagnose pancreatic cancer patients. AI is expected to play a vital role in advancing pancreatic cancer prediction and diagnosis. Further research is required to provide data that support clinical decisions in health care. ", doi="10.2196/44248", url="https://www.jmir.org/2023/1/e44248", url="http://www.ncbi.nlm.nih.gov/pubmed/37000507" } @Article{info:doi/10.2196/41101, author="Raso, Kristy-Lee and Suen, Michael and Turner, Jane and Khatri, Sonia and Lin, Yanlan and Wildbore, Carolyn and Becerril-Martinez, Guillermo and Le Page, Philip and Tan, Yee Sim and Egger, Sam and Vardy, Janette", title="Prehabilitation Before Gastrointestinal Cancer Surgery: Protocol for an Implementation Study", journal="JMIR Res Protoc", year="2023", month="Mar", day="27", volume="12", pages="e41101", keywords="prehabilitation", keywords="gastrointestinal", keywords="cancer", keywords="surgery", keywords="exercise", keywords="nutrition", keywords="telehealth", keywords="colorectal", keywords="psychological", abstract="Background: Surgery remains the standard curative treatment for early-stage colorectal and upper gastrointestinal cancer. Reduced preoperative functional capacity, nutritional status, and psychological well-being are associated with poor postoperative outcomes. Prehabilitation aims to improve preoperative functional reserves through physical, nutritional, and psychological interventions. Yet, how it transitions from a trial setting to being integrated into a real-world health setting is unknown. Objective: The primary aim is to evaluate the implementation of a multimodal (supervised exercise, nutrition, and nursing support) prehabilitation program into standard care for patients with gastrointestinal cancer (colorectal and upper gastrointestinal cancer) scheduled for curative intent surgery. The secondary aim is to determine the impact of a multimodal prehabilitation program on functional capacity, nutritional and psychological status, and surgical outcomes. Methods: This is an implementation study that will investigate a multimodal prehabilitation intervention, in a nonblinded, nonrandomized, single-group, pre-post design. Patients diagnosed with colorectal and upper gastrointestinal cancer scheduled for potentially curative intent surgery at Concord Repatriation General Hospital, with ?14 intervention days prior to surgery and are medically cleared to exercise will be eligible. The study will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance Evaluation Framework. Results: The protocol was approved in December 2019 by the Concord Repatriation General Hospital Human Research Ethics Committee (reference number 2019/PID13679). Recruitment commenced in January 2020. In response to the COVID-19 pandemic, recruitment was paused in March 2020 and reopened in August 2020 with remote or telehealth intervention adaptations. Recruitment ended on December 31, 2021. Over the 16-month recruitment period, a total of 77 participants were recruited. Conclusions: Prehabilitation represents an opportunity to maximize functional capacity and improve surgical outcomes. The study will provide guidance and contribute to the evidence on the integration of prehabilitation into standard care using adaptive models of health care delivery including telehealth. Trial Registration: Australian and New Zealand Clinical Trials Registry ACTR 12620000409976; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378974\&isReview=true International Registered Report Identifier (IRRID): RR1-10.2196/41101 ", doi="10.2196/41101", url="https://www.researchprotocols.org/2023/1/e41101", url="http://www.ncbi.nlm.nih.gov/pubmed/36972114" } @Article{info:doi/10.2196/41355, author="Burnette, Colin and Sivesind, E. Torunn and Dellavalle, Robert", title="From the Cochrane Library: Optical Coherence Tomography for Diagnosing Skin Cancer in Adults", journal="JMIR Dermatol", year="2023", month="Mar", day="13", volume="6", pages="e41355", keywords="systematic review", keywords="optical coherence tomography", keywords="tomography", keywords="diagnostic imaging", keywords="optical imaging", keywords="laser", keywords="skin lesions", keywords="diagnostic techniques", keywords="melanoma", keywords="basal cell carcinoma", keywords="cancer", keywords="skin cancer", keywords="clinical", keywords="cell", keywords="diagnose", doi="10.2196/41355", url="https://derma.jmir.org/2023/1/e41355", url="http://www.ncbi.nlm.nih.gov/pubmed/37632933" } @Article{info:doi/10.2196/44105, author="Kang, Danbee and Kim, Sooyeon and Kim, Hyunsoo and Lee, Mangyeong and Kong, Sun-Young and Chang, Jung Yoon and Sim, Hoon Sung and Kim, Yeon-Joo and Cho, Juhee", title="Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study", journal="JMIR Public Health Surveill", year="2023", month="Mar", day="8", volume="9", pages="e44105", keywords="surveillance", keywords="patient-reported outcome", keywords="symptoms", keywords="cancer", abstract="Background: Over 90\% of patients with cancer experience 1 or more symptoms caused directly by cancer or its treatment. These symptoms negatively impact on the completion of planned treatment as well as patients' health-related quality of life (HRQoL). It often results in serious complications and even life-threatening outcomes. Thus, it has been recommended that surveillance of symptom burden should be performed and managed during cancer treatment. However, differences in symptom profiles in various patients with cancer have not been fully elucidated for use in performing surveillance in the real world. Objective: This study aims to evaluate the burden of symptoms in patients with various types of cancers during chemotherapy or radiation therapy using the PRO-CTCAE (Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events) and its impact on quality of life. Methods: We performed a cross-sectional study of patients undergoing outpatient-based chemotherapy, radiation therapy, or both at the National Cancer Center at Goyang or at the Samsung Medical Center in Seoul, Korea between December 2017 and January 2018. To evaluate cancer-specific symptom burden, we developed 10 subsets for using the PRO-CTCAE-Korean. To measure HRQoL, we used the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Participants answered questions prior to their clinic appointments on tablets. Multivariable linear regression was used to analyze symptoms based on cancer type and to evaluate the association between the PRO-CTCAE items and the EORTC QLQ-C30 summary score. Results: The mean age (SD) of the patients was 55.0 (11.9) years, and 39.94\% (540/1352) were male. Overall, symptoms in the gastrointestinal category were the most dominant in all cancers. Fatigue (1034/1352, 76.48\%), decreased appetite (884/1352, 65.38\%), and numbness and tingling (778/1352, 57.54\%) were the most frequently reported. Patients reported more local symptoms caused by a specific cancer. In terms of nonsite-specific symptoms, patients commonly reported concentration (587/1352, 43.42\%), anxiety (647/1352, 47.86\%), and general pain (605/1352, 44.75\%). More than 50\% of patients with colorectal (69/127, 54.3\%), gynecologic (63/112, 56.3\%), breast (252/411, 61.3\%), and lung cancers (121/234, 51.7\%) experienced decreased libido, whereas 67/112 (59.8\%) patients with gynecologic cancer and lymphoma/myeloma reported pain during sexual intercourse. Patients with breast, gastric, and liver cancers were more likely to have the hand-foot syndrome. Worsening PRO-CTCAE scores were associated with poor HRQoL (eg, fatigue: coefficient --8.15; 95\% CI --9.32 to --6.97), difficulty in achieving and maintaining erection (coefficient --8.07; 95\% CI --14.52 to --1.61), poor concentration (coefficient --7.54; 95\% CI --9.06 to --6.01), and dizziness (coefficient --7.24; 95\% CI --8.92 to --5.55). Conclusions: The frequency and severity of symptoms differed by cancer types. Higher symptom burden was associated with poor HRQoL, which suggests the importance of appropriate surveillance of PRO symptoms during cancer treatment. Considering patients had comprehensive symptoms, it is necessary to include a holistic approach in the symptom monitoring and management strategies based on comprehensive patient-reported outcome measurements. ", doi="10.2196/44105", url="https://publichealth.jmir.org/2023/1/e44105", url="http://www.ncbi.nlm.nih.gov/pubmed/36884274" } @Article{info:doi/10.2196/43832, author="Xue, Peng and Si, Mingyu and Qin, Dongxu and Wei, Bingrui and Seery, Samuel and Ye, Zichen and Chen, Mingyang and Wang, Sumeng and Song, Cheng and Zhang, Bo and Ding, Ming and Zhang, Wenling and Bai, Anying and Yan, Huijiao and Dang, Le and Zhao, Yuqian and Rezhake, Remila and Zhang, Shaokai and Qiao, Youlin and Qu, Yimin and Jiang, Yu", title="Unassisted Clinicians Versus Deep Learning--Assisted Clinicians in Image-Based Cancer Diagnostics: Systematic Review With Meta-analysis", journal="J Med Internet Res", year="2023", month="Mar", day="2", volume="25", pages="e43832", keywords="deep learning", keywords="cancer diagnosis", keywords="systematic review", keywords="meta-analysis", abstract="Background: A number of publications have demonstrated that deep learning (DL) algorithms matched or outperformed clinicians in image-based cancer diagnostics, but these algorithms are frequently considered as opponents rather than partners. Despite the clinicians-in-the-loop DL approach having great potential, no study has systematically quantified the diagnostic accuracy of clinicians with and without the assistance of DL in image-based cancer identification. Objective: We systematically quantified the diagnostic accuracy of clinicians with and without the assistance of DL in image-based cancer identification. Methods: PubMed, Embase, IEEEXplore, and the Cochrane Library were searched for studies published between January 1, 2012, and December 7, 2021. Any type of study design was permitted that focused on comparing unassisted clinicians and DL-assisted clinicians in cancer identification using medical imaging. Studies using medical waveform-data graphics material and those investigating image segmentation rather than classification were excluded. Studies providing binary diagnostic accuracy data and contingency tables were included for further meta-analysis. Two subgroups were defined and analyzed, including cancer type and imaging modality. Results: In total, 9796 studies were identified, of which 48 were deemed eligible for systematic review. Twenty-five of these studies made comparisons between unassisted clinicians and DL-assisted clinicians and provided sufficient data for statistical synthesis. We found a pooled sensitivity of 83\% (95\% CI 80\%-86\%) for unassisted clinicians and 88\% (95\% CI 86\%-90\%) for DL-assisted clinicians. Pooled specificity was 86\% (95\% CI 83\%-88\%) for unassisted clinicians and 88\% (95\% CI 85\%-90\%) for DL-assisted clinicians. The pooled sensitivity and specificity values for DL-assisted clinicians were higher than for unassisted clinicians, at ratios of 1.07 (95\% CI 1.05-1.09) and 1.03 (95\% CI 1.02-1.05), respectively. Similar diagnostic performance by DL-assisted clinicians was also observed across the predefined subgroups. Conclusions: The diagnostic performance of DL-assisted clinicians appears better than unassisted clinicians in image-based cancer identification. However, caution should be exercised, because the evidence provided in the reviewed studies does not cover all the minutiae involved in real-world clinical practice. Combining qualitative insights from clinical practice with data-science approaches may improve DL-assisted practice, although further research is required. Trial Registration: PROSPERO CRD42021281372; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=281372 ", doi="10.2196/43832", url="https://www.jmir.org/2023/1/e43832", url="http://www.ncbi.nlm.nih.gov/pubmed/36862499" } @Article{info:doi/10.2196/38362, author="Helissey, Carole and Cavallero, Sophie and Mondot, Stanislas and Parnot, Charles and Yssaad, Halima and Becherirat, Selma and Guitard, Nathalie and Thery, H{\'e}l{\`e}ne and Schernberg, Antoine and Breitwiller, Hugo and Chargari, Cyrus and Francois, Sabine", title="Correlation Between Serum and Urine Biomarkers and the Intensity of Acute Radiation Cystitis in Patients Treated With Radiation Therapy for Localized Prostate Cancer: Protocol for the Radiotoxicity Bladder Biomarkers (RABBIO) Study", journal="JMIR Res Protoc", year="2023", month="Jan", day="10", volume="12", pages="e38362", keywords="radiation cystitis", keywords="radiotoxicity", keywords="urine", keywords="bladder", keywords="serum", keywords="quality of life", keywords="remote monitoring", keywords="biomarker", keywords="prostate", keywords="cancer", keywords="immunosorbent", keywords="urology", keywords="cytometry", keywords="protocol", keywords="telehealth", keywords="telemedicine", keywords="health platform", keywords="online platform", keywords="monitor", keywords="digital health", keywords="radiotherapy", keywords="radiation", keywords="risk", keywords="inflammation", keywords="inflammatory", keywords="sequencing", keywords="biopsy", keywords="biopsies", keywords="gene expression", keywords="protein", keywords="microbiology", keywords="cystitis", keywords="microbe", keywords="microbiota", keywords="RNA", keywords="proteomics", keywords="assay", keywords="algorithm", keywords="oncology", keywords="radiology", keywords="radiation therapy", keywords="prostate cancer", keywords="diagnostic", abstract="Background: Despite improvements in radiation techniques, pelvic radiotherapy is responsible for acute and delayed bladder adverse events, defined as radiation cystitis. The initial symptoms of bladder injury secondary to pelvic irradiation are likely to occur during treatment or within 3 months of radiotherapy in approximately 50\% of irradiated patients, and have a significant impact on their quality of life. The pathophysiology of radiation cystitis is not well understood, particularly because of the risk of complications associated with access to bladder tissue after irradiation, which limits our ability to study this process and develop treatments. Objective: It is an original study combining digital data collection to monitor patients' symptoms and biological markers during irradiation. The main objective of our study is to evaluate the correlation of biological biomarkers with the intensity of acute radiation cystitis and the quality of life of patients, assessed with the digital telemonitoring platform Cureety. Methods: Patients with intermediate-risk localized prostate cancer who are eligible for localized radiotherapy will be included. Inflammatory biomarkers will be analyzed in urine and blood samples before the start of radiotherapy and at weeks 4, 12, and 48 of irradiation, through quantitative methods such as a multiplex Luminex assay, flow cytometry, and enzyme-linked immunosorbent assay. We will also characterize the patients' gut and urine microbiota composition using 16S ribosomal RNA sequencing technology. Between sample collection visits, patients will complete various questionnaires related to radiation cystitis symptoms (using the International Prostate Symptom Score), adverse events, and quality of life (using the Functional Assessment of Cancer Therapy--Prostate questionnaire), using the Cureety digital remote monitoring platform. Upon receipt of the questionnaires, an algorithm will process the information and classify patients in accordance with the severity of symptoms and adverse events reported on the basis of Common Terminology Criteria for Adverse Events and International Prostate Symptom Score standards. This will allow us to correlate levels of urinary, blood, and fecal biomarkers with the severity of acute radiation cystitis symptoms and patient-reported quality of life. Results: The study started in March 2022. We estimate a recruitment period of approximately 18 months, and the final results are expected in 2024. Conclusions: This prospective study is the first to explore the overexpression of inflammatory proteins in fluid biopsies from patients with symptoms of acute radiation cystitis. In addition, the 1-year follow-up after treatment will allow us to predict which patients are at risk of late radiation cystitis and to refer them for radioprotective treatment. The results of this study will allow us to develop strategies to limit radiation damage to the bladder and improve the quality of life of patients. Trial Registration: ClinicalTrials.gov NCT05246774; https://clinicaltrials.gov/ct2/show/NCT05246774?term=NCT05246774 International Registered Report Identifier (IRRID): DERR1-10.2196/38362 ", doi="10.2196/38362", url="https://www.researchprotocols.org/2023/1/e38362", url="http://www.ncbi.nlm.nih.gov/pubmed/36626198" } @Article{info:doi/10.2196/37144, author="Maksimenko, Jelena and Rodrigues, Pereira Pedro and Nakazawa-Mikla{\vs}evi{\v c}a, Miki and Pinto, David and Mikla{\vs}evi{\v c}s, Edvins and Trofimovi{\v c}s, Genadijs and Gardovskis, J?nis and Cardoso, Fatima and Cardoso, Jo{\~a}o Maria", title="Effectiveness of Secondary Risk--Reducing Strategies in Patients With Unilateral Breast Cancer With Pathogenic Variants of BRCA1 and BRCA2 Subjected to Breast-Conserving Surgery: Evidence-Based Simulation Study", journal="JMIR Form Res", year="2022", month="Dec", day="29", volume="6", number="12", pages="e37144", keywords="BRCA1 and BRCA2", keywords="secondary prophylactic strategies", keywords="breast-conserving therapy", keywords="breast cancer", abstract="Background: Approximately 62\% of patients with breast cancer with a pathogenic variant (BRCA1 or BRCA2) undergo primary breast-conserving therapy. Objective: The study aims to develop a personalized risk management decision support tool for carriers of a pathogenic variant (BRCA1 or BRCA2) who underwent breast-conserving therapy for unilateral early-stage breast cancer. Methods: We developed a Bayesian network model of a hypothetical cohort of carriers of BRCA1 or BRCA2 diagnosed with stage I/II unilateral breast cancer and treated with breast-conserving treatment who underwent subsequent second primary cancer risk--reducing strategies. Using event dependencies structured according to expert knowledge and conditional probabilities obtained from published evidence, we predicted the 40-year overall survival rate of different risk-reducing strategies for 144 cohorts of women defined by the type of pathogenic variants (BRCA1 or BRCA2), age at primary breast cancer diagnosis, breast cancer subtype, stage of primary breast cancer, and presence or absence of adjuvant chemotherapy. Results: Absence of adjuvant chemotherapy was the most powerful factor that was linked to a dramatic decline in survival. There was a negligible decline in the mortality in patients with triple-negative breast cancer, who received no chemotherapy and underwent any secondary risk--reducing strategy, compared with surveillance. The potential survival benefit from any risk-reducing strategy was more modest in patients with triple-negative breast cancer who received chemotherapy compared with patients with luminal breast cancer. However, most patients with triple-negative breast cancer in stage I benefited from bilateral risk-reducing mastectomy and risk-reducing salpingo-oophorectomy or just risk-reducing salpingo-oophorectomy. Most patients with luminal stage I/II unilateral breast cancer benefited from bilateral risk-reducing mastectomy and risk-reducing salpingo-oophorectomy. The impact of risk-reducing salpingo-oophorectomy in patients with luminal breast cancer in stage I/II increased with age. Most older patients with the BRCA1 and BRCA2 pathogenic variants in exons 12-24/25 with luminal breast cancer may gain a similar survival benefit from other risk-reducing strategies or surveillance. Conclusions: Our study showed that it is mandatory to consider the complex interplay between the types of BRCA1 and BRCA2 pathogenic variants, age at primary breast cancer diagnosis, breast cancer subtype and stage, and received systemic treatment. As no prospective study results are available at the moment, our simulation model, which will integrate a decision support system in the near future, could facilitate the conversation between the health care provider and patient and help to weigh all the options for risk-reducing strategies leading to a more balanced decision. ", doi="10.2196/37144", url="https://formative.jmir.org/2022/12/e37144", url="http://www.ncbi.nlm.nih.gov/pubmed/36580360" } @Article{info:doi/10.2196/42908, author="Beuken, M. Maik J. and Kanera, M. Iris and Ezendam, Maria Nicole Paulina and Braun, Susy and Zoet, Martijn", title="Identification and Potential Use of Clusters of Patients With Colorectal Cancer and Patients With Prostate Cancer in Clinical Practice: Explorative Mixed Methods Study", journal="JMIR Cancer", year="2022", month="Dec", day="27", volume="8", number="4", pages="e42908", keywords="colorectal cancer", keywords="prostate cancer", keywords="referral to aftercare", keywords="patient clusters", keywords="cluster analysis", keywords="K-means cluster algorithm", keywords="multiple-factor analysis", keywords="expert panel group interviews", keywords="interview", keywords="cancer", keywords="patient", keywords="usability", keywords="clinical", keywords="colorectal", keywords="recovery", abstract="Background: A steady increase in colorectal and prostate cancer survivors and patients with these cancers is expected in the upcoming years. As a result of primary cancer treatments, patients have numerous additional complaints, increasing the need for cancer aftercare. However, referrals to appropriate cancer aftercare remain inadequate, despite a wide range of aftercare options. Caregivers and patients often do not know which aftercare is the most appropriate for the individual patient. Since characteristics and complaints of patients within a diagnosis group may differ, predefined patient clusters could provide substantive and efficient support for professionals in the conversation about aftercare. By using advanced data analysis methods, clusters of patients who are different from one another within a diagnosis group can be identified. Objective: This study had a 2-fold objective: (1) to identify, visualize, and describe potential patient clusters within the colorectal and prostate cancer population and (2) to explore the potential usability of these clusters in clinical practice. Methods: First, we used cross-sectional data from patients with colorectal cancer and patients with prostate cancer provided by the population-based PROFILES (Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship) registry, which were originally collected between 2008 and 2012. To identify and visualize different clusters among the 2 patient populations, we conducted cluster analyses by applying the K-means algorithm and multiple-factor analyses. Second, in a qualitative study, we presented the patient clusters to patients with prostate, patients with colorectal cancer, and oncology professionals. To assess the usability of these clusters, we held expert panel group interviews. The interviews were video recorded and transcribed. Three researchers independently performed content-directed data analyses to understand and describe the qualitative data. Quotes illustrate the most important results. Results: We identified 3 patient clusters among colorectal cancer cases (n=3989) and 5 patient clusters among prostate cancer cases (n=696), which were described in tabular form. Patient experts (6/8, 75\%) and professional experts (17/20, 85\%) recognized the patient clustering based on distinguishing variables. However, the tabular form was evaluated as less applicable in clinical practice. Instead, the experts suggested the development of a conversation tool (eg, decision tree) to guide professionals through the hierarchy of variables. In addition, participants suggested that information about possible aftercare initiatives should be offered and integrated. This would also ensure a good overview and seemed to be a precondition for finding suitable aftercare. Conclusions: This study demonstrates that a fully data-driven approach can be used to identify distinguishable and recognizable (ie, in routine care) patient clusters in large data sets within cancer populations. Patient clusters can be a source of support for health professionals in the aftercare conversation. These clusters, when integrated into a smart digital conversation and referral tool, might be an opportunity to improve referral to cancer aftercare. Trial Registration: Netherlands Trial Register NL9226; https://trialsearch.who.int/Trial2.aspx?TrialID=NL9226 ", doi="10.2196/42908", url="https://cancer.jmir.org/2022/4/e42908", url="http://www.ncbi.nlm.nih.gov/pubmed/36574281" } @Article{info:doi/10.2196/40185, author="Yang, Shi-Ping and Lin, Xiang-Ying and Hu, Min and Cai, Cheng-Fu", title="The Prognostic and Predictive Effects of Human Papillomavirus Status in Hypopharyngeal Carcinoma: Population-Based Study", journal="JMIR Public Health Surveill", year="2022", month="Dec", day="16", volume="8", number="12", pages="e40185", keywords="hypopharyngeal carcinoma", keywords="human papillomavirus", keywords="HPV", keywords="chemotherapy", keywords="radiotherapy", keywords="prognosis", keywords="cancer", keywords="carcinoma", abstract="Background: The role of the Human Papillomavirus (HPV) status in patients with hypopharyngeal squamous cell carcinoma (HSCC) remains controversial. Objective: Our aim was to determine the prognostic and predictive effects of HPV status in patients with locally advanced HSCC (stage III-IVB) receiving primary radiotherapy. Methods: Patients diagnosed with stage III-IVB HSCC between 2010 and 2016 were identified. HPV status, demographics, clinicopathological characteristics, treatment, and survival data were captured. Kaplan-Meier analysis, multivariable Cox regression analysis, and propensity score matching analysis were performed. Results: We identified 531 patients in this study and 142 (26.7\%) patients with HPV-positive diseases. No significant differences were observed between those with HPV-negative and HPV-positive diseases with regard to demographics, clinicopathological characteristics, and chemotherapy use. HPV-positive HSCC had better head and neck cancer-specific survival (HNCSS; P=.001) and overall survival (OS; P<.001) compared to those with HPV-negative tumors. Similar results were found using the multivariable Cox regression analysis. Sensitivity analyses showed that the receipt of chemotherapy was associated with significantly improving HNCSS (P<.001) and OS (P<.001) compared to not receiving chemotherapy in HPV-negative HSCC, whereas comparable HNCSS (P=.59) and OS (P=.12) were found between both treatment arms in HPV-positive HSCC. Similar results were found after propensity score matching. Conclusions: Approximately one-quarter of HSCC may be HPV-related, and HPV-positive HSCC is associated with improved survival outcomes. Furthermore, additional chemotherapy appears to be not related to a survival benefit in patients with HPV-positive tumors who received primary radiotherapy. ", doi="10.2196/40185", url="https://publichealth.jmir.org/2022/12/e40185", url="http://www.ncbi.nlm.nih.gov/pubmed/36525304" } @Article{info:doi/10.2196/36632, author="Rasmussen, Lind Ida Marie and Soerensen, Vest Anne and M{\o}ller, Kirstine Anne and Persson, Fredberg Gitte and Palshof, Andreas Jesper and Taarnh{\o}j, Assam Gry and Pappot, Helle", title="Individualizing the Oncological Treatment of Patients With Metastatic Non--Clear Cell Renal Cell Carcinoma by Using Gene Sequencing and Patient-Reported Outcomes: Protocol for the INDIGO Study", journal="JMIR Res Protoc", year="2022", month="Sep", day="15", volume="11", number="9", pages="e36632", keywords="patient-reported outcome", keywords="electronic patient-reported outcome", keywords="renal cell carcinoma", keywords="non--clear cell renal cell carcinoma", keywords="health-related quality of life", keywords="oncology", keywords="targeted therapy", keywords="precision medicine", keywords="eHealth", keywords="outcome", keywords="patient-reported", abstract="Background: No phase 3 studies have yet been conducted for patients with non--clear cell (CC) renal cell carcinoma (RCC) exclusively due to the rare occurrence of the disease and the heterogenicity in tumor morphology. Consequently, there is no evidence of the optimal treatment, and new approaches are needed. One approach is individualizing treatment based on the gene sequencing of tumor tissue. Additionally, recent studies involving the patient-reported outcomes (PROs) of patients treated for metastatic cancer have shown significant benefits for quality of life, median overall survival, and overall survival. The use of gene sequencing and PROs can be of great importance to patients with rare cancer types, including patients with non-CC RCC, and should be investigated in clinical trials, especially for cases where evidence based on phase 3 studies is difficult to obtain. Objective: We describe the INDIGO study, in which patients, based on gene analyses, will be allocated into 4 treatment arms containing 14 treatments and use electronic PROs. We aim to improve the treatment of patients with non-CC RCC. The end points in the study will be the overall response rate (complete and partial) in the total patient population, which will be based on the RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria, and the time to treatment failure. Methods: INDIGO is a prospective phase 2 trial, and 30 patients will be enrolled. The patients will receive systemic treatment based on genetic analyses of their tumor tissue. All patients will receive electronic questionnaires in a dedicated app---a questionnaire regarding symptoms and side effects and another regarding health-related quality of life. Depending on the treatment regimen, the patients will be seen by a medical doctor every third, fourth, or sixth week, and the effect of the systemic treatment will be evaluated every 6 weeks via a computed tomography scan. The study has been approved by the Danish Medicines Agency and the National Committee on Health Research Ethics (approval number: H-19041833), complies with good clinical practice guidelines, follows the General Data Protection Regulation, and is registered at the Capital Region of Denmark. Results: Recruitment started in March 2020, and at the time of submitting this paper (June 2022), a total of 9 patients have been enrolled. Conclusions: We aim to explore methods for improving the treatment outcomes of patients with non-CC RCC, and the INDIGO study will contribute further data on personalized medicine for rare types of RCC and provide new knowledge on the active use of electronic PROs. Trial Registration: ClinicalTrials.gov NCT04644432, https://clinicaltrials.gov/ct2/show/NCT04644432 ; European Union Drug Regulating Authorities Clinical Trials Database 2019-001316-38, https://tinyurl.com/2p8mb4aw International Registered Report Identifier (IRRID): DERR1-10.2196/36632 ", doi="10.2196/36632", url="https://www.researchprotocols.org/2022/9/e36632", url="http://www.ncbi.nlm.nih.gov/pubmed/36107483" } @Article{info:doi/10.2196/38874, author="Patel, Sunil and McClintock, Chad and Booth, Christopher and Merchant, Shaila and Heneghan, Carl and Bankhead, Clare", title="The Variations in Care and Real-world Outcomes in Individuals With Rectal Cancer: Protocol for the Ontario Rectal Cancer Cohort", journal="JMIR Res Protoc", year="2022", month="Aug", day="5", volume="11", number="8", pages="e38874", keywords="rectal cancer", keywords="survival", keywords="adherence to care", keywords="regional variability", abstract="Background: Individuals with rectal cancer require a number of pretreatment investigations, often require multidisciplinary treatment, and require ongoing follow-ups after treatment is completed. Due to the complexity of treatments, large variations in practice patterns and outcomes have been identified. At present, few comprehensive, population-level data sets are available for assessing interventions and outcomes in this group. Objective: Our study aims to create a comprehensive database of individuals with rectal cancer who have been treated in a single-payer, universal health care system. This database will provide an excellent resource that investigators can use to study variations in the delivery of care to and real-world outcomes of this population. Methods: The Ontario Rectal Cancer Cohort database will include comprehensive details about the management and outcomes of individuals with rectal cancer who have been diagnosed in Ontario, Canada (population: 14.6 million), between 2010 and 2019. Linked administrative data sets will be used to construct this comprehensive database. Individual and care provider characteristics, investigations, treatments, follow-ups, and outcomes will be derived and linked. Surgical pathology details, including the stage of disease, histopathology characteristics, and the quality of surgical excision, will be included. Ethics approval for this study was obtained through the Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board. Results: Approximately 20,000 individuals who meet the inclusion criteria for this study have been identified. Data analysis is ongoing, with an expected completion date of March 2023. This study was funded through the Canadian Institute of Health Research Operating Grant. Conclusions: The Ontario Rectal Cancer Cohort will include a comprehensive data set of individuals with rectal cancer who received care within a single-payer, universal health care system. This cohort will be used to determine factors associated with regional variability and adherence to recommended care, and it will allow for an assessment of a number of understudied areas within the delivery of rectal cancer treatment. International Registered Report Identifier (IRRID): RR1-10.2196/38874 ", doi="10.2196/38874", url="https://www.researchprotocols.org/2022/8/e38874", url="http://www.ncbi.nlm.nih.gov/pubmed/35930352" } @Article{info:doi/10.2196/34461, author="Moreira, In{\^e}s and Bartosch, Carla and Teixeira, Manuel and Ferreira, Marta", title="Molecular Classification of Endometrial Carcinoma: Protocol for a Cohort Study", journal="JMIR Res Protoc", year="2022", month="Aug", day="4", volume="11", number="8", pages="e34461", keywords="endometrial carcinoma", keywords="molecular classification", keywords="prognosis", keywords="POLE", keywords="mismatch repair", keywords="p53", abstract="Background: Endometrial carcinoma (EC) is the most common gynecologic malignancy in developed countries and the fourth most frequent in women worldwide. The cornerstone of treatment for EC is surgery. Clinicopathological features are currently used to help determine the individual risk of recurrence and the need for adjuvant treatment after surgery. Nonetheless, there is significant interobserver variability in assigning histologic subtype when using a morphological classification, revealing the need for a more unified approach. The Cancer Genome Atlas (TCGA) project identified 4 distinct prognostic EC subtypes based on genomic abnormalities. Surrogate assays including 3 immunohistochemical markers (p53, MSH6, and PMS2) and 1 molecular test (mutation analysis of the exonuclease domain of DNA polymerase epsilon; POLE) allowed the development and validation of a simplified molecular classifier that correlates with the TCGA classification, has prognostic value, and can easily be used in clinical practice. This molecular classification categorizes EC in 4 subtypes: POLE mutated, mismatch repair--deficient, p53 abnormal, and no specific molecular profile. Applying this classification in clinical practice will help tailor adjuvant treatment decisions. Objective: The aim of this study is to retrospectively apply this novel molecular classification to a cohort of patients with EC treated in a comprehensive cancer center, to assess its applicability in clinical practice, to evaluate clinical outcomes by molecular subtypes, and to assess its prognostic value. Methods: In this retrospective cohort study, patients with primary EC diagnosed during and after 2013 and treated or followed at our institution, after definite surgery, will be included. Demographic and clinicopathological data will be obtained from electronic health records and from pathology reports. Laboratory methods will include immunohistochemical study of p53 and mismatch repair proteins, as well as POLE mutational analysis by genetic sequencing. The primary end point is recurrence-free survival and secondary end points are disease-specific survival and overall survival. A descriptive analysis of variables will be carried out. Survival analysis will be performed using the Kaplan-Meier method and the groups will be compared using the log-rank test. Results: This protocol was reviewed and approved by the Instituto Portugu{\^e}s de Oncologia do Porto, Portugal, ethics committee in October 2021; patient selection from our cancer registry began the same month. A total of 160 patients will be included. This work will present real-life results that will allow a better understanding of the Portuguese EC population and the distribution of the molecular subgroups throughout. We will use these results to understand the prognostic value of this classification in our population and its role in adjuvant therapy decisions. This study is anticipated to conclude in December 2022. Conclusions: This study will provide important information regarding these women's outcomes according to this new molecular classification and will support its use when discussing a patient's need for adjuvant treatment. International Registered Report Identifier (IRRID): PRR1-10.2196/34461 ", doi="10.2196/34461", url="https://www.researchprotocols.org/2022/8/e34461", url="http://www.ncbi.nlm.nih.gov/pubmed/35925678" } @Article{info:doi/10.2196/35565, author="Baudin, Cl{\'e}mence and Lussey-Lepoutre, Charlotte and Bressand, Alice and Buffet, Camille and Menegaux, Fabrice and Soret, Marine and Broggio, David and Bassinet, C{\'e}line and Huet, Christelle and Armengol, Gemma and Leenhardt, Laurence and Bernier, Marie-Odile", title="Salivary Dysfunctions and Consequences After Radioiodine Treatment for Thyroid Cancer: Protocol for a Self-Controlled Study (START Study)", journal="JMIR Res Protoc", year="2022", month="Jul", day="22", volume="11", number="7", pages="e35565", keywords="radioiodine", keywords="thyroid cancer", keywords="epidemiology", keywords="self-controlled study", keywords="salivary gland", keywords="lacrimal gland", keywords="dysfunction", keywords="protocol", abstract="Background: Following radioiodine (131I) therapy of differentiated thyroid cancer, the salivary glands may become inflamed, leading to dysfunctions and decreases in patients' nutritional status and quality of life. The incidence of these dysfunctions after 131I-therapy is poorly known, and no clinical or genetic factors have been identified to date to define at-risk patients, which would allow the delivered activity to be adapted to the expected risk of salivary dysfunctions. Objective: The aims of this study are to estimate the incidence of salivary dysfunctions, and consequences on the quality of life and nutritional status for patients after 131I-therapy; to characterize at-risk patients of developing posttreatment dysfunctions using clinical, biomolecular, and biochemical factors; and to validate a dosimetric method to calculate the dose received at the salivary gland level for analyzing the dose-response relationship between absorbed doses to salivary glands and salivary dysfunctions. Methods: This prospective study aims to include patients for whom 131I-therapy is indicated as part of the treatment for differentiated thyroid cancer in a Paris hospital (40 and 80 patients in the 1.1 GBq and 3.7 GBq groups, respectively). The follow-up is based on three scheduled visits: at inclusion (T0, immediately before 131I-therapy), and at 6 months (T6) and 18 months (T18) posttreatment. For each visit, questionnaires on salivary dysfunctions (validated French tool), quality of life (Hospital Anxiety and Depression scale, Medical Outcomes Study 36-Item Short Form Survey), and nutritional status (visual analog scale) are administered by a trained clinical research associate. At T0 and T6, saliva samples and individual measurements of the salivary flow, without and with salivary glands stimulation, are performed. External thermoluminescent dosimeters are positioned on the skin opposite the salivary glands and at the sternal fork immediately before 131I administration and removed after 5 days. From the doses recorded by the dosimeters, an estimation of the dose received at the salivary glands will be carried out using physical and computational phantoms. Genetic and epigenetic analyses will be performed to search for potential biomarkers of the predisposition to develop salivary dysfunctions after 131I-therapy. Results: A total of 139 patients (99 women, 71.2\%; mean age 47.4, SD 14.3 years) were enrolled in the study between September 2020 and April 2021 (45 and 94 patients in the 1.1 GBq and 3.7G Bq groups, respectively). T6 follow-up is complete and T18 follow-up is currently underway. Statistical analyses will assess the links between salivary dysfunctions and absorbed doses to the salivary glands, accounting for associated factors. Moreover, impacts on the patients' quality of life will be analyzed. Conclusions: To our knowledge, this study is the first to investigate the risk of salivary dysfunctions (using both objective and subjective indicators) in relation to organ (salivary glands) doses, based on individual dosimeter records and dose reconstructions. The results will allow the identification of patients at risk of salivary dysfunctions and will permit clinicians to propose a more adapted follow-up and/or countermeasures to adverse effects. Trial Registration: ClinicalTrials.gov NCT04876287; https://clinicaltrials.gov/ct2/show/NCT04876287 International Registered Report Identifier (IRRID): DERR1-10.2196/35565 ", doi="10.2196/35565", url="https://www.researchprotocols.org/2022/7/e35565", url="http://www.ncbi.nlm.nih.gov/pubmed/35867385" } @Article{info:doi/10.2196/27694, author="Chen, Pei-Chin and Lu, Yun-Ru and Kang, Yi-No and Chang, Chun-Chao", title="The Accuracy of Artificial Intelligence in the Endoscopic Diagnosis of Early Gastric Cancer: Pooled Analysis Study", journal="J Med Internet Res", year="2022", month="May", day="16", volume="24", number="5", pages="e27694", keywords="artificial intelligence", keywords="early gastric cancer", keywords="endoscopy", abstract="Background: Artificial intelligence (AI) for gastric cancer diagnosis has been discussed in recent years. The role of AI in early gastric cancer is more important than in advanced gastric cancer since early gastric cancer is not easily identified in clinical practice. However, to our knowledge, past syntheses appear to have limited focus on the populations with early gastric cancer. Objective: The purpose of this study is to evaluate the diagnostic accuracy of AI in the diagnosis of early gastric cancer from endoscopic images. Methods: We conducted a systematic review from database inception to June 2020 of all studies assessing the performance of AI in the endoscopic diagnosis of early gastric cancer. Studies not concerning early gastric cancer were excluded. The outcome of interest was the diagnostic accuracy (comprising sensitivity, specificity, and accuracy) of AI systems. Study quality was assessed on the basis of the revised Quality Assessment of Diagnostic Accuracy Studies. Meta-analysis was primarily based on a bivariate mixed-effects model. A summary receiver operating curve and a hierarchical summary receiver operating curve were constructed, and the area under the curve was computed. Results: We analyzed 12 retrospective case control studies (n=11,685) in which AI identified early gastric cancer from endoscopic images. The pooled sensitivity and specificity of AI for early gastric cancer diagnosis were 0.86 (95\% CI 0.75-0.92) and 0.90 (95\% CI 0.84-0.93), respectively. The area under the curve was 0.94. Sensitivity analysis of studies using support vector machines and narrow-band imaging demonstrated more consistent results. Conclusions: For early gastric cancer, to our knowledge, this was the first synthesis study on the use of endoscopic images in AI in diagnosis. AI may support the diagnosis of early gastric cancer. However, the collocation of imaging techniques and optimal algorithms remain unclear. Competing models of AI for the diagnosis of early gastric cancer are worthy of future investigation. Trial Registration: PROSPERO CRD42020193223; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=193223 ", doi="10.2196/27694", url="https://www.jmir.org/2022/5/e27694", url="http://www.ncbi.nlm.nih.gov/pubmed/35576561" } @Article{info:doi/10.2196/34292, author="Regueiro, Cristina and Codesido, Laura and Garc{\'i}a-Nimo, Laura and Zarraqui{\~n}os, Sara and Remedios, David and Rodr{\'i}guez-Blanco, Arturo and Sinde, Esteban and Fern{\'a}ndez-de-Ana, Catalina and Cubiella, Joaqu{\'i}n", title="Effect of the Nutraceutical Micodigest 2.0 on the Complication Rate of Colorectal Cancer Surgery With Curative Intent: Protocol for a Placebo-Controlled Double-blind Randomized Clinical Trial", journal="JMIR Res Protoc", year="2022", month="May", day="16", volume="11", number="5", pages="e34292", keywords="colorectal cancer", keywords="surgery complications", keywords="gut microbiota", keywords="inflammatory pattern", keywords="nutritional status", keywords="nutraceutical", keywords="postsurgery", keywords="colorectal", keywords="cancer", keywords="colon", abstract="Background: Most colorectal cancer patients diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used for the prevention of infectious postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in colorectal cancer patients. The combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. Objective: Based on this hypothesis, we have designed a double-bind, randomized clinical trial to evaluate the effect of the nutraceutical fungal extract Micodigest 2.0 on complications of surgery for colorectal cancer resection. Methods: Colorectal cancer candidates for surgery will be considered for inclusion in the study. After evaluation by the multidisciplinary tumor board, patients who meet selection criteria will be screened, stratified according to tumor location, and randomly allocated to be treated with Micodigest 2.0 or placebo. Treatment will be continued until admission for surgery (4-6 weeks). Participants will undergo a medical and clinical evaluation including baseline and preadmission quality of life, microbiome composition, inflammatory and nutritional status, adverse events, and adherence assessments. The main end point of the study is the surgery complication rate. We will evaluate complications using the Clavien-Dindo classification. It will be necessary to recruit 144 patients to find a relevant clinical difference. We will also evaluate the effect of the nutraceutical on microbiome composition, inflammatory response, nutritional status, and quality of life, as well as the effect of these variables on surgical complications. Results: This study was funded in 2020 by the Center for Industrial Technology Development. Recruitment began in September 2021 and is expected to be completed in September 2022. Data will be analyzed and the results will be disseminated in 2023. Conclusions: The results of this protocol study could help to reduce surgery complications in patients with colorectal cancer using the new treatment Micodigest. This study could also identify new features associated with colorectal surgery complications. In summary, this study trial could improve the management of colorectal cancer patients. Trial Registration: Clinical Trials.gov NCT04821258; https://clinicaltrials.gov/ct2/show/NCT04821258 International Registered Report Identifier (IRRID): DERR1-10.2196/34292 ", doi="10.2196/34292", url="https://www.researchprotocols.org/2022/5/e34292", url="http://www.ncbi.nlm.nih.gov/pubmed/35576566" } @Article{info:doi/10.2196/35243, author="Ronellenfitsch, Ulrich and Mathis, Nika and Friedrichs, Juliane and Kleeff, J{\"o}rg", title="Lymph Node Yield in Gastrointestinal Cancer Surgery With or Without Prior Neoadjuvant Therapy: Protocol for a Systematic Review and Meta-analysis", journal="JMIR Res Protoc", year="2022", month="Apr", day="28", volume="11", number="4", pages="e35243", keywords="lymph node yield", keywords="lymph node harvest", keywords="neoadjuvant therapy", keywords="neoadjuvant chemotherapy", keywords="neoadjuvant radiotherapy", keywords="surgery", keywords="resection", keywords="gastrointestinal cancer", keywords="chemotherapy", keywords="cancer", abstract="Background: Lymph node yield is the number of lymph nodes retrieved during oncological resection and histopathologically identified in the resection specimen. It is an important surrogate parameter for assessing the oncological radicality of the resection of gastrointestinal carcinomas, as well as a prognostic factor in these diseases. It remains unclear if and to what extent neoadjuvant chemotherapy, radiotherapy, or chemoradiotherapy, which have become established treatments for carcinoma of the esophagus, stomach, and rectum and are increasingly used in pancreatic carcinoma, affect the lymph node yield. Objective: This systematic review with meta-analysis is conducted with the aim of summarizing the available evidence regarding the lymph node yield, an oncological surrogate marker, in patients with gastrointestinal carcinomas undergoing surgery after neoadjuvant therapy compared to those undergoing surgery without neoadjuvant therapy. Methods: Randomized and nonrandomized studies comparing oncological resection of esophageal, stomach, pancreatic, and rectal carcinoma with and without prior neoadjuvant therapy are eligible for inclusion regardless of study design. Publications will be identified with a defined search strategy in 2 electronic databases: PubMed and Cochrane Library. The primary endpoint of the analysis is the number of lymph nodes identified in the resected specimen. Secondary endpoints include the number of harvested metastatic lymph nodes, operation time, postoperative complications, pathological TNM staging, and overall and recurrence-free survival time. Using suitable statistical methods, the endpoints between patients with and without neoadjuvant therapy, as well as in defined subgroups (neoadjuvant chemotherapy, radiotherapy, or chemoradiotherapy; and patients with esophageal, gastric, pancreatic, or rectal cancer), will be compared. Results: The literature search and data collection started in October 2021. Results are expected to be published in mid-2022. Conclusions: This meta-analysis will provide the most up-to-date and complete summary of the evidence on an association between neoadjuvant therapy and lymph node yield in gastrointestinal cancer surgery. The underlying hypothesis is that neoadjuvant therapy decreases the number and size of lymph nodes through lymphocyte depletion and radiation-induced fibrosis, thus leading to a lower possible lymph node yield. The findings of the meta-analysis will show if this hypothesis is supported by evidence. Trial Registration: PROSPERO CRD218459; https://www.crd.york.ac.uk/prospero/display\_record.php?ID=CRD42021218459 International Registered Report Identifier (IRRID): DERR1-10.2196/35243 ", doi="10.2196/35243", url="https://www.researchprotocols.org/2022/4/e35243", url="http://www.ncbi.nlm.nih.gov/pubmed/35482374" } @Article{info:doi/10.2196/33240, author="Mudaranthakam, Pal Dinesh and Gajewski, Byron and Krebill, Hope and Coulter, James and Springer, Michelle and Calhoun, Elizabeth and Hughes, Dorothy and Mayo, Matthew and Doolittle, Gary", title="Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants", journal="JMIR Cancer", year="2022", month="Apr", day="21", volume="8", number="2", pages="e33240", keywords="rural residents", keywords="clinical trials", keywords="screening", keywords="cancer", keywords="patients", keywords="lung cancer", keywords="health policy epidemiology", keywords="cancer patients", keywords="electronic screening logs", keywords="electronic screening", abstract="Background: The National Clinical Trials Network program conducts phase 2 or phase 3 treatment trials across all National Cancer Institute's designated cancer centers. Participant accrual across these clinical trials is a critical factor in deciding their success. Cancer centers that cater to rural populations, such as The University of Kansas Cancer Center, have an additional responsibility to ensure rural residents have access and are well represented across these studies. Objective: There are scant data available regarding the factors that act as barriers to the accrual of rural residents in these clinical trials. This study aims to use electronic screening logs that were used to gather patient data at several participating sites in The Kansas University of Cancer Center's Catchment area. Methods: Screening log data were used to assess what clinical trial participation barriers are faced by these patients. Additionally, the differences in clinical trial participation barriers were compared between rural and urban participating sites. Results: Analysis revealed that the hospital location rural urban category, defined as whether the hospital was in an urban or rural setting, had a medium effect on enrolment of patients in breast cancer and lung cancer trials (Cohen d=0.7). Additionally, the hospital location category had a medium effect on the proportion of recurrent lung cancer cases at the time of screening (d=0.6). Conclusions: In consideration of the financially hostile nature of cancer treatment as well as geographical and transportation barriers, clinical trials extended to rural communities are uniquely positioned to alleviate the burden of nonmedical costs in trial participation. However, these options can be far less feasible for patients in rural settings. Since the number of patients with cancer who are eligible for a clinical trial is already limited by the stringent eligibility criteria required of such a complex disease, improving accessibility for rural patients should be a greater focus in health policy. ", doi="10.2196/33240", url="https://cancer.jmir.org/2022/2/e33240", url="http://www.ncbi.nlm.nih.gov/pubmed/35451964" } @Article{info:doi/10.2196/31887, author="Borgonovo, Giulia and Vettus, Elen and Greco, Alessandra and Leo, Anna Laura and Faletra, Fulvio Francesco and Klersy, Catherine and Curti, Moreno and Valli, Mariacarla", title="Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Patients With Breast Cancer: Protocol for a Multi-Institutional Prospective Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="21", volume="11", number="4", pages="e31887", keywords="breast cancer", keywords="cardiotoxicity", keywords="cardiac diagnostic imaging", keywords="radiotherapy", keywords="chemotherapy", abstract="Background: The incidence of breast cancer is rising worldwide. Recent advances in systemic and local treatments have significantly improved survival rates of patients having early breast cancer. In the last decade, great attention has been paid to the prevention and early detection of cardiotoxicity induced by breast cancer treatments. Systemic therapy-related cardiac toxicities have been extensively studied. Radiotherapy, an essential component of breast cancer treatment, can also increase the risk of heart diseases. Consequently, it is important to balance the expected benefits of cancer treatment with cardiovascular risk and to identify strategies to prevent cardiotoxicity and improve long-term outcomes and quality of life for these patients. Objective: This CardioTox Breast study aims to investigate the use of cardiac imaging, based on cardiac magnetic resonance and echocardiography, and to identify associated circulating biomarkers to assess early tissue changes in chemo-induced and radiation-induced cardiotoxicity in the time window of 12 months after the end of radiotherapy in patients with breast cancer. Methods: The CardioTox Breast trial is a multicenter observational prospective longitudinal study. We aim to enroll 150 women with stage I-III unilateral breast cancer, treated with breast conserving surgery, who planned to receive radiotherapy with or without systemic therapy. Baseline and follow-up data include cardiac measurements based on cardiac magnetic resonance imaging, echocardiography, and circulating biomarkers of cardiac toxicity. Results: This study details the protocol of the CardioTox Breast trial. Recruitment started in September 2020. The results of this study will not be published until data are mature for the final analysis of the primary study end point. Conclusions: The CardioTox Breast study is designed to investigate the effects of systemic and radiation therapy on myocardial function and structure, thus providing additional evidence on whether cardiac magnetic resonance is the optimal screening imaging for cardiotoxicity. Trial Registration: ClinicalTrials.gov NCT04790266; https://clinicaltrials.gov/ct2/show/NCT04790266 International Registered Report Identifier (IRRID): DERR1-10.2196/31887 ", doi="10.2196/31887", url="https://www.researchprotocols.org/2022/4/e31887", url="http://www.ncbi.nlm.nih.gov/pubmed/35451989" } @Article{info:doi/10.2196/31350, author="Penz, Dianne Erika and Fenton, John Benjamin and Hu, Nianping and Marciniuk, Darcy", title="Economic Burden of Chronic Obstructive Pulmonary Disease and Lung Cancer Between 2000 and 2015 in Saskatchewan: Study Protocol", journal="JMIR Res Protoc", year="2022", month="Mar", day="4", volume="11", number="3", pages="e31350", keywords="lung cancer", keywords="COPD", keywords="chronic obstructive pulmonary disease", keywords="productivity loss", keywords="years of life lost", keywords="premature years of life lost", keywords="working years lost", keywords="economic burden of disease", keywords="lung disease", keywords="health economics", keywords="Stats Canada", keywords="epidemiology", keywords="pulmonary disease", keywords="pulmonary health", keywords="disease burden", abstract="Background: Chronic obstructive pulmonary disease (COPD) and lung cancer are both detrimental diseases that present great burdens on society. Years of life lost (YLL), premature years of life lost (PYLL), working years lost (WYL), and productivity loss are all effective measures in identifying economic burden of disease. Objective: We propose a population-based study to analyze comprehensive provincial cohorts of Saskatchewan residents with COPD, lung cancer, and combined COPD and lung cancer in order to identify the burden these diseases present. Methods: Saskatchewan residents over the age of 35 years who had COPD, lung cancer, or both, between January 1, 2000, and December 31, 2015, will be identified and used in this study. Data for analysis including age, gender, and date of death, alongside Statistics Canada income estimates, will be used to estimate productivity loss and WYL. Statistics Canada life tables will be used to calculate YLL and PYLL by subtracting the patients' ages at death by their life expectancies, adjusted using sex and age at death.We will link the Saskatchewan cancer registry with Saskatchewan health administrative databases to create three cohorts: (1) COPD; (2) lung cancer; and (3) COPD and lung cancer. Individuals with lung cancer will be identified using ICDO-T (International Classification of Diseases for Oncology-Topography) codes, and those with COPD will be defined and identified as individuals who had at least 1 visit to a physician with a diagnosis of COPD or 1 hospital separation with a diagnosis of COPD. Those without a valid health care coverage for a consecutive 12 months prior to the first diagnostic code will be excluded from the study. Those with a combined diagnosis of COPD and lung cancer will be identified as individuals who were diagnosed with COPD in the 12 months following their lung cancer diagnosis or anytime preceding their lung cancer diagnosis. Results: As of April 2021, we have had access to all relevant data for this study, have received funding (January 2020), and have begun the preliminary analysis of our data set. Conclusions: It is well documented that COPD and lung cancer are both destructive diseases in terms of YLL, PYLL, WYL, and productivity loss; however, no studies have been conducted to analyze a cohort with combined COPD and lung cancer. Understanding the economic burden associated with each of our 3 cohorts is necessary in understanding and thus reducing the societal impact of COPD and lung cancer. International Registered Report Identifier (IRRID): RR1-10.2196/31350 ", doi="10.2196/31350", url="https://www.researchprotocols.org/2022/3/e31350", url="http://www.ncbi.nlm.nih.gov/pubmed/35254280" } @Article{info:doi/10.2196/29124, author="Hibler, A. Elizabeth and Fought, J. Angela and Kershaw, N. Kiarri and Molsberry, Rebecca and Nowakowski, Virginia and Lindner, Deborah", title="Novel Interactive Tool for Breast and Ovarian Cancer Risk Assessment (Bright Pink Assess Your Risk): Development and Usability Study", journal="J Med Internet Res", year="2022", month="Feb", day="24", volume="24", number="2", pages="e29124", keywords="breast cancer", keywords="ovarian cancer", keywords="risk assessment", keywords="genetic testing", abstract="Background: The lifetime risk of breast and ovarian cancer is significantly higher among women with genetic susceptibility or a strong family history. However, current risk assessment tools and clinical practices may identify only 10\% of asymptomatic carriers of susceptibility genes. Bright Pink developed the Assess Your Risk (AYR) tool to estimate breast and ovarian cancer risk through a user-friendly, informative web-based quiz for risk assessment at the population level. Objective: This study aims to present the AYR tool, describe AYR users, and present evidence that AYR works as expected by comparing classification using the AYR tool with gold standard genetic testing guidelines. Methods: The AYR is a recently developed population-level risk assessment tool that includes 26 questions based on the National Comprehensive Cancer Network (NCCN) guidelines and factors from other commonly used risk assessment tools. We included all women who completed the AYR between November 2018 and January 2019, with the exception of self-reported cancer or no knowledge of family history. We compared AYR classifications with those that were independently created using NCCN criteria using measures of validity and the McNemar test. Results: There were 143,657 AYR completions, and most participants were either at increased or average risk for breast cancer or ovarian cancer (137,315/143,657, 95.59\%). Using our estimates of increased and average risk as the gold standard, based on the NCCN guidelines, we estimated the sensitivity and specificity for the AYR algorithm--generated risk categories as 100\% and 89.9\%, respectively (P<.001). The specificity improved when we considered the additional questions asked by the AYR to define increased risk, which were not examined by the NCCN criteria. By race, ethnicity, and age group; we found that the lowest observed specificity was for the Asian race (85.9\%) and the 30 to 39 years age group (87.6\%) for the AYR-generated categories compared with the NCCN criteria. Conclusions: These results demonstrate that Bright Pink's AYR is an accurate tool for use by the general population to identify women at increased risk of breast and ovarian cancer. We plan to validate the tool longitudinally in future studies, including the impact of race, ethnicity, and age on breast and ovarian cancer risk assessment. ", doi="10.2196/29124", url="https://www.jmir.org/2022/2/e29124", url="http://www.ncbi.nlm.nih.gov/pubmed/35200148" } @Article{info:doi/10.2196/33996, author="Nowlin, Ross and Wirtz, Alexis and Wenger, David and Ottwell, Ryan and Cook, Courtney and Arthur, Wade and Sallee, Brigitte and Levin, Jarad and Hartwell, Micah and Wright, Drew and Sealey, Meghan and Zhu, Lan and Vassar, Matt", title="Spin in Abstracts of Systematic Reviews and Meta-analyses of Melanoma Therapies: Cross-sectional Analysis", journal="JMIR Dermatol", year="2022", month="Feb", day="24", volume="5", number="1", pages="e33996", keywords="melanoma", keywords="spin", keywords="melanoma treatment", keywords="skin conditions", keywords="skin", keywords="misinterpreting data", keywords="misinterpretation", keywords="skin cancer", abstract="Background: Spin is defined as the misrepresentation of a study's results, which may lead to misperceptions or misinterpretation of the findings. Spin has previously been found in randomized controlled trials and systematic reviews of acne vulgaris treatments and treatments of various nondermatological conditions. Objective: The purpose of this study was to quantify the presence of spin in abstracts of systematic reviews and meta-analyses of melanoma therapies and identify any related secondary characteristics of these articles. Methods: We used a cross-sectional approach on June 2, 2020, to search the MEDLINE and Embase databases from their inception. To meet inclusion criteria, a study was required to be a systematic review or meta-analysis pertaining to the treatment of melanoma in human subjects, and reported in English. We used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) definition of systematic reviews and meta-analyses. Data were extracted in a masked, duplicate fashion. We conducted a powered bivariate linear regression and calculated odds ratios for each study characteristic. Results: A total of 200 systematic reviews met the inclusion criteria. We identified spin in 38\% (n=76) of the abstracts. The most common type of spin found was type 3 (selective reporting of or overemphasis on efficacy outcomes or analysis favoring the beneficial effect of the experimental intervention), occurring 40 times; the least common was type 2 (title claims or suggests a beneficial effect of the experimental intervention not supported by the findings), which was not present in any included abstracts. We found that abstracts pertaining to pharmacologic interventions were 3.84 times more likely to contain spin. The likelihood of an article containing spin has decreased annually (adjusted odds ratio 0.91, 95\% CI 0.84-0.99). No significant correlation between funding source or other study characteristics and the presence of spin was identified. Conclusions: We have found that spin is fairly common in the abstracts of systematic reviews of melanoma treatments, but the prevalence of spin in these abstracts has been declining from 1992-2020. ", doi="10.2196/33996", url="https://derma.jmir.org/2022/1/e33996", url="http://www.ncbi.nlm.nih.gov/pubmed/37632865" } @Article{info:doi/10.2196/31255, author="Meghiref, Yasmine and Parnot, Charles and Duverger, Claire and Difoum, Lilly Fran{\c{c}}oise and Gourden, Audrey and Yssaad, Halima and Leiterer, Caroline and Bedekovic, Caroline and Blanchard, Julien and Nait Ammar, Houria and Schernberg, Antoine and Vanquaethem, H{\'e}l{\`e}ne and Helissey, Carole", title="The Use of Telemedicine in Cancer Clinical Trials: Connect-Patient-to-Doctor Prospective Study", journal="JMIR Cancer", year="2022", month="Jan", day="27", volume="8", number="1", pages="e31255", keywords="telemedicine", keywords="clinical trial", keywords="neoplasms", keywords="patient-reported outcome measures", abstract="Background: Telemedicine is currently being adopted for the management of patients in routine care. However, its use remains limited in the context of clinical trials. Objective: This study aimed to demonstrate the feasibility of telemonitoring and patient-reported outcomes collection in the context of clinical trials. Methods: The patients who were included in an interventional oncology clinical trial were eligible. The patients were registered with a digital tool to respond to a patient-reported outcomes questionnaire (ePRO) based on CTCAE (The Common Terminology Criteria for Adverse Events, National Cancer Institute), version 5.0, personalized to their pathology and treatment. An algorithm evaluated the health status of the patient based on the reported adverse events, with a classification in 4 different states (correct, compromise, state to be monitored, or critical state). The main objective was to evaluate the feasibility of remote monitoring via a connected platform of patients included in a clinical trial. Results: From July 1, 2020, to March 31, 2021, 39 patients were included. The median age was 71 years (range 41-94); 74\% (n=29) were male, and 59\% (n=23) had metastatic disease. Out of the 969 ePRO questionnaires completed over the course of the study, 77.0\% (n=746) were classified as ``correct,'' 10.9\% (n=106) as ``compromised,'' and 12.1\% (n=117) as ``to be monitored'' or ``critical.'' The median response time was 7 days (IQR 7-15.5), and 76\% (25/33) of the patients were compliant. Out of the 35 patients who answered a satisfaction questionnaire, 95\% (n=33) were satisfied or very satisfied with the tool, and 85\% (n=30) were satisfied with their relationship with the health care team. There were 5 unscheduled hospitalizations during the study period. Conclusions: Remote monitoring in clinical trials is feasible, with a high level of patient participation and satisfaction. It benefits patients, but it also ensures the high quality of the trial through the early management of adverse events and better knowledge of the tolerance profile of experimental treatments. This e-technology will likely be deployed more widely in our clinical trials. ", doi="10.2196/31255", url="https://cancer.jmir.org/2022/1/e31255", url="http://www.ncbi.nlm.nih.gov/pubmed/34921544" } @Article{info:doi/10.2196/19750, author="Flippo, Brittany and Stone, Bradley and Stahr, Shelbie and Khalil, Mahmoud and Davis, Rodney and Kamel, Mohamed and Singh, Manisha", title="Short-Term and Long-Term Renal Outcomes in Patients With Obesity After Minimally Invasive Versus Open Partial Nephrectomy for the Treatment of Renal Cancer: Retrospective Study", journal="JMIR Form Res", year="2022", month="Jan", day="10", volume="6", number="1", pages="e19750", keywords="renal outcomes", keywords="renal cell carcinoma", keywords="minimally invasive vs open partial nephrectomy", keywords="obesity", keywords="kidney", keywords="cancer", keywords="surgery", keywords="retrospective", keywords="outcome", keywords="short-term", keywords="long-term", abstract="Background: Obesity is significantly associated with renal cell carcinoma. Surgery is the preferred treatment for demarcated lesions of renal cell carcinoma; however, obesity increases the complexity of surgical outcomes. Minimally invasive surgical techniques are preferred over open partial nephrectomy (OPN), but controversy remains regarding the most efficacious technique in patients with obesity. Objective: This study aims to determine whether minimally invasive partial nephrectomy (MIPN) or OPN better preserves renal function and investigate short- and long-term renal outcomes in patients with obesity undergoing a partial nephrectomy. Methods: We conducted a retrospective chart review of 242 adult patients aged ?18 years who underwent MIPN or OPN between January 1, 2005, and December 31, 2016, at the University of Arkansas for Medical Sciences. Using creatinine as a measure of kidney function, patients' preoperative levels were compared with their postoperative levels in 2-time frames: short (3-6 months postsurgery) or long (>6 months). The primary outcome was the change in creatinine values from preoperative to >6 months postoperatively in patients with obesity. Secondary outcomes included the change in creatinine values from preoperative to 3 to 6 months postoperatively in patients with obesity who underwent MIPN versus OPN. We also analyzed the creatinine values of nonobese patients (BMI <30) who underwent partial nephrectomy using the same time frames. Unconditional logistic regression was used to estimate crude and multivariable-adjusted odds ratios (ORs) and 95\% CI to observe associations between surgery type and changes in creatinine values from while stratifying for obesity. Results: A total of 140 patients were included in the study, of whom 75 were obese and 65 were nonobese. At >6 months after MIPN (n=20), the odds of patients with obesity having a decrease or no change in creatinine values was 1.24 times higher than those who had OPN (n=13; OR 1.24, 95\% CI 0.299-6.729; P=.80). At 3 to 6 months after MIPN (n=27), the odds were 0.62 times lower than those after OPN (n=17; OR 0.62, 95\% CI 0.140-2.753; P=.56). In the nonobese group, at 3 to 6 months after undergoing minimally invasive surgery (n=18), the odds of having a decrease or no change in creatinine values was 4.86 times higher than those who had open surgery (n=21; OR 4.86, 95\% CI 1.085-21.809; P=.04). At more than 6 months after MIPN (n=14), the odds were 4.13 times higher than those after OPN (n=11; OR 4.13, 95\% CI 0.579-29.485; P=.16). Conclusions: We observed a nonstatistically significant preservation of renal function in patients with obesity who underwent OPN at 3 to 6 months postoperatively. Conversely, after 6 months, the same was true for MIPN, indicating the long-term benefit of MIPN. In the nonobese group, MIPN was favored over OPN.? ", doi="10.2196/19750", url="https://formative.jmir.org/2022/1/e19750", url="http://www.ncbi.nlm.nih.gov/pubmed/35006078" } @Article{info:doi/10.2196/31128, author="Shahzadi, Kiran Syeda and Karuvantevida, Noushad and Banerjee, Yajnavalka", title="A Venomics Approach to the Identification and Characterization of Bioactive Peptides From Animal Venoms for Colorectal Cancer Therapy: Protocol for a Proof-of-Concept Study", journal="JMIR Res Protoc", year="2021", month="Dec", day="21", volume="10", number="12", pages="e31128", keywords="animal venoms", keywords="colorectal cancer", keywords="bioactive peptides", keywords="high-throughput screening", keywords="venom", keywords="cancer", keywords="colorectal", keywords="peptide", keywords="screening", keywords="treatment", keywords="conceptual", keywords="characterize", keywords="development", keywords="therapy", abstract="Background: Cancer is the third leading cause of death in the United Arab Emirates (UAE), after cardiovascular diseases and accidents. In the UAE, colorectal cancer (CRC) is the first and fourth most common cancer in males and females, respectively. Several treatment modalities have been employed for cancer treatment, such as surgery, radiotherapy, chemotherapy, hormone replacement therapy, and immunotherapy. These treatment modalities often elicit adverse effects on normal cells, causing toxic side effects. To circumvent these toxicities, there has been an increased impetus towards the identification of alternate treatment strategies. Animal venoms are rich sources of pharmacologically active polypeptides and proteins. Objective: In this proof-of-concept study, we will apply a high-throughput venomics strategy to identify and characterize anticancer bioactive peptides (BAPs) from 20 different animal venoms, specifically targeting CRC. We chose to focus on CRC because it is one of the foremost health issues in the UAE. Methods: In the initial study, we will screen 2500 different peptides derived from 20 different animal venoms for anticancer activity specifically directed against 3 CRC cell lines and two control cell lines employing the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) colorimetric assay for cytotoxicity. Of the 20 venoms, 3 that exhibit specific and potent anticancer activity directed against the 3 CRC cell lines will be selected; and from these 3 venoms, the specific peptides with anti-CRC activity will be isolated and characterized. Results: This study is at the protocol development stage only, and as such, no results are available. However, we have initiated the groundwork required to disseminate the proposed study, which includes culturing of colorectal cancer cell lines and preparation of venom screens. Conclusions: In summary, the proposed study will generate therapeutic leads to manage and treat one of the leading health issues in the UAE, namely, CRC. International Registered Report Identifier (IRRID): PRR1-10.2196/31128 ", doi="10.2196/31128", url="https://www.researchprotocols.org/2021/12/e31128", url="http://www.ncbi.nlm.nih.gov/pubmed/34932002" } @Article{info:doi/10.2196/29912, author="Abdulkarim, S. Louay and Motley, J. Richard", title="First-line Advanced Cutaneous Melanoma Treatments: Where Do We Stand?", journal="JMIR Cancer", year="2021", month="Dec", day="15", volume="7", number="4", pages="e29912", keywords="advanced cutaneous melanoma", keywords="first-line treatments", keywords="immunotherapy", keywords="targeted therapy", keywords="combinational therapy", keywords="dermatologic adverse events", keywords="cutaneous side effects", doi="10.2196/29912", url="https://cancer.jmir.org/2021/4/e29912", url="http://www.ncbi.nlm.nih.gov/pubmed/34914610" } @Article{info:doi/10.2196/20028, author="Ye, Ye and Barapatre, Seemran and Davis, K. Michael and Elliston, O. Keith and Davatzikos, Christos and Fedorov, Andrey and Fillion-Robin, Jean-Christophe and Foster, Ian and Gilbertson, R. John and Lasso, Andras and Miller, V. James and Morgan, Martin and Pieper, Steve and Raumann, E. Brigitte and Sarachan, D. Brion and Savova, Guergana and Silverstein, C. Jonathan and Taylor, P. Donald and Zelnis, B. Joyce and Zhang, Guo-Qiang and Cuticchia, Jamie and Becich, J. Michael", title="Open-source Software Sustainability Models: Initial White Paper From the Informatics Technology for Cancer Research Sustainability and Industry Partnership Working Group", journal="J Med Internet Res", year="2021", month="Dec", day="2", volume="23", number="12", pages="e20028", keywords="open-source software", keywords="sustainability", keywords="licensing model", keywords="financial model", keywords="product management", keywords="cancer informatics", abstract="Background: The National Cancer Institute Informatics Technology for Cancer Research (ITCR) program provides a series of funding mechanisms to create an ecosystem of open-source software (OSS) that serves the needs of cancer research. As the ITCR ecosystem substantially grows, it faces the challenge of the long-term sustainability of the software being developed by ITCR grantees. To address this challenge, the ITCR sustainability and industry partnership working group (SIP-WG) was convened in 2019. Objective: The charter of the SIP-WG is to investigate options to enhance the long-term sustainability of the OSS being developed by ITCR, in part by developing a collection of business model archetypes that can serve as sustainability plans for ITCR OSS development initiatives. The working group assembled models from the ITCR program, from other studies, and from the engagement of its extensive network of relationships with other organizations (eg, Chan Zuckerberg Initiative, Open Source Initiative, and Software Sustainability Institute) in support of this objective. Methods: This paper reviews the existing sustainability models and describes 10 OSS use cases disseminated by the SIP-WG and others, including 3D Slicer, Bioconductor, Cytoscape, Globus, i2b2 (Informatics for Integrating Biology and the Bedside) and tranSMART, Insight Toolkit, Linux, Observational Health Data Sciences and Informatics tools, R, and REDCap (Research Electronic Data Capture), in 10 sustainability aspects: governance, documentation, code quality, support, ecosystem collaboration, security, legal, finance, marketing, and dependency hygiene. Results: Information available to the public reveals that all 10 OSS have effective governance, comprehensive documentation, high code quality, reliable dependency hygiene, strong user and developer support, and active marketing. These OSS include a variety of licensing models (eg, general public license version 2, general public license version 3, Berkeley Software Distribution, and Apache 3) and financial models (eg, federal research funding, industry and membership support, and commercial support). However, detailed information on ecosystem collaboration and security is not publicly provided by most OSS. Conclusions: We recommend 6 essential attributes for research software: alignment with unmet scientific needs, a dedicated development team, a vibrant user community, a feasible licensing model, a sustainable financial model, and effective product management. We also stress important actions to be considered in future ITCR activities that involve the discussion of the sustainability and licensing models for ITCR OSS, the establishment of a central library, the allocation of consulting resources to code quality control, ecosystem collaboration, security, and dependency hygiene. ", doi="10.2196/20028", url="https://www.jmir.org/2021/12/e20028", url="http://www.ncbi.nlm.nih.gov/pubmed/34860667" } @Article{info:doi/10.2196/27893, author="El Haidari, Rana and Anota, Amelie and Abou-Abbas, Linda and Nerich, Virginie", title="Health-Related Quality of Life of Lebanese Women With Breast Cancer: Protocol for a Prospective Cohort Study", journal="JMIR Res Protoc", year="2021", month="Nov", day="23", volume="10", number="11", pages="e27893", keywords="breast cancer", keywords="cohort", keywords="health-related quality of life", keywords="Lebanese women", keywords="prospective", abstract="Background: In the past few decades, Lebanon has witnessed a significant increase in the incidence rates of women diagnosed with breast cancer. This increase, which is associated with the advancements in treatment modalities, emphasizes the need to evaluate the health-related quality of life (HRQoL) of women with breast cancer and to compare its patterns before and after breast-conserving surgery (BCS). Objective: This study aims to describe changes in HRQoL according to body image pre- and post-BCS and just before initiation of adjuvant therapy in newly diagnosed patients with breast cancer in Lebanon. Methods: A prospective cohort study targeting Lebanese women newly diagnosed with breast cancer and who have an indication for BCS will be conducted in 2 health care facilities. Baseline characteristics and clinical data will be collected. The European Organization for Research and Treatment of Cancer Quality-of-Life cancer-specific and breast cancer--specific questionnaires will be used to assess HRQoL. The outcomes will be measured at baseline and 1 day after breast surgery. The primary outcome will be the body image dimensions of the Quality-of-Life breast cancer--specific questionnaire. Statistical analyses will include descriptive statistics, paired 2-tailed t test, and stepwise multiple regression. A total of 120 patients will be required. Results: A total of 120 patients were enrolled in the study. Future outcomes will be published in professional peer-reviewed health-related research journals. Conclusions: This study is strengthened by its follow-up nature, allowing us to draw conclusions about causality. The results of this study will identify the most affected components of HRQoL, as well as the factors that could play a role in improving HRQoL among women undergoing BCS. The findings of this study will help decision makers, physicians, and social workers to design a comprehensive program with multidisciplinary components for the management and care of patients with breast cancer in Lebanon. International Registered Report Identifier (IRRID): DERR1-10.2196/27893 ", doi="10.2196/27893", url="https://www.researchprotocols.org/2021/11/e27893", url="http://www.ncbi.nlm.nih.gov/pubmed/34817382" } @Article{info:doi/10.2196/25976, author="Yang, Shi-Ping and Su, Hui-Luan and Chen, Xiu-Bei and Hua, Li and Chen, Jian-Xian and Hu, Min and Lei, Jian and Wu, San-Gang and Zhou, Juan", title="Long-Term Survival Among Histological Subtypes in Advanced Epithelial Ovarian Cancer: Population-Based Study Using the Surveillance, Epidemiology, and End Results Database", journal="JMIR Public Health Surveill", year="2021", month="Nov", day="17", volume="7", number="11", pages="e25976", keywords="ovarian epithelial carcinoma", keywords="survivors", keywords="histology", keywords="survival rate", keywords="survival", keywords="ovarian", keywords="cancer", keywords="surveillance", keywords="epidemiology", keywords="women's health", keywords="reproductive health", keywords="Surveillance, Epidemiology, and End Results", keywords="ovary", keywords="oncology", keywords="survivorship", keywords="long-term outcome", keywords="epithelial", abstract="Background: Actual long-term survival rates for advanced epithelial ovarian cancer (EOC) are rarely reported. Objective: This study aimed to assess the role of histological subtypes in predicting the prognosis among long-term survivors (?5 years) of advanced EOC. Methods: We performed a retrospective analysis of data among patients with stage III-IV EOC diagnosed from 2000 to 2014 using the Surveillance, Epidemiology, and End Results cancer data of the United States. We used the chi-square test, Kaplan--Meier analysis, and multivariate Cox proportional hazards model for the analyses. Results: We included 8050 patients in this study, including 6929 (86.1\%), 743 (9.2\%), 237 (2.9\%), and 141 (1.8\%) patients with serous, endometrioid, clear cell, and mucinous tumors, respectively. With a median follow-up of 91 months, the most common cause of death was primary ovarian cancer (80.3\%), followed by other cancers (8.1\%), other causes of death (7.3\%), cardiac-related death (3.2\%), and nonmalignant pulmonary disease (3.2\%). Patients with the serous subtype were more likely to die from primary ovarian cancer, and patients with the mucinous subtype were more likely to die from other cancers and cardiac-related disease. Multivariate Cox analysis showed that patients with endometrioid (hazard ratio [HR] 0.534, P<.001), mucinous (HR 0.454, P<.001), and clear cell (HR 0.563, P<.001) subtypes showed better ovarian cancer-specific survival than those with the serous subtype. Similar results were found regarding overall survival. However, ovarian cancer--specific survival and overall survival were comparable among those with endometrioid, clear cell, and mucinous tumors. Conclusions: Ovarian cancer remains the primary cause of death in long-term ovarian cancer survivors. Moreover, the probability of death was significantly different among those with different histological subtypes. It is important for clinicians to individualize?the?surveillance?program for long-term ovarian cancer survivors. ", doi="10.2196/25976", url="https://publichealth.jmir.org/2021/11/e25976", url="http://www.ncbi.nlm.nih.gov/pubmed/34787583" } @Article{info:doi/10.2196/27073, author="Elsamany, Shereef and Elbaiomy, Mohamed and Zeeneldin, Ahmed and Tashkandi, Emad and Hassanin, Fayza and Abdelhafeez, Nafisa and O Al-Shamsi, Humaid and Bukhari, Nedal and Elemam, Omima", title="Suggested Modifications to the Management of Patients With Breast Cancer During the COVID-19 Pandemic: Web-Based Survey Study", journal="JMIR Cancer", year="2021", month="Nov", day="15", volume="7", number="4", pages="e27073", keywords="breast cancer", keywords="COVID-19", keywords="pandemic", keywords="web-based survey", keywords="treatment modification", keywords="oncology", keywords="treatment", keywords="modification", keywords="risk", keywords="infection", abstract="Background: Management of patients with cancer in the current era of the COVID-19 pandemic poses a significant challenge to health care systems. Breast cancer is the most common cancer internationally. Breast cancer is a disease that involves surgery, chemotherapy, hormonal therapy, targeted therapy, radiotherapy, and, more recently, immunotherapy in its management plan. The immune system requires months to recover from these medications, and this condition is even worse in patients with metastatic breast cancer who need ongoing treatment with these drugs. Some of these drugs, such as inhibitors of cyclin-dependent kinases 4 and 6, can cause rare but life-threating lung inflammation. Patients with breast cancer who have metastatic disease to the lungs can experience deterioration of disease symptoms with COVID-19 infection. Oncologists treating patients with breast cancer are facing a difficult situation regarding treatment choice. The impact that COVID-19 has had on breast cancer care is unknown, including how to provide the best care possible without compromising patient and community safety. Objective: The aim of this study was to explore the views of oncologists regarding the management of patients with breast cancer during the COVID-19 pandemic. Methods: A web-based SurveyMonkey questionnaire was submitted to licensed oncologists involved in breast cancer management in Saudi Arabia, Egypt, and United Arab Emirates. The survey focused on characteristics of the participants, infection risk among patients with cancer, and possible treatment modifications related to different types of breast cancer. Results: The survey was completed by 82 participants. For early hormone receptor (HR)--positive, human epidermal growth factor receptor 2 (HER2)--negative breast cancer, 61 of the 82 participants (74\%) supported using neoadjuvant hormonal therapy in selected patients, and 58\% (48/82) preferred giving 6 over 8 cycles of adjuvant chemotherapy when indicated. Only 43\% (35/82) preferred inhibitors of cyclin-dependent kinases 4 and 6 with hormonal therapy as the first-line treatment in all patients with metastatic HR-positive disease. A total of 55 of the 82 participants (67\%) supported using adjuvant trastuzumab for 6 instead of 12 months in selected patients with HER2-positive breast cancer. For metastatic HER2-positive, HR-positive breast cancer, 80\% of participants (66/82) supported the use of hormonal therapy with dual anti-HER2 blockade in selected patients. The preferred choice of first-line treatment in metastatic triple negative patients with BRCA mutation and programmed cell death 1 ligand 1 (PD-L1) <1\% was poly(adenosine diphosphate--ribose) polymerase inhibitor according to 41\% (34/82) of the participants, and atezolizumab with nab-paclitaxel was preferred for PD-L1 >1\% according to 71\% (58/82) of the participants. Conclusions: Several modifications in breast cancer management were supported by the survey participants. These modifications need to be discussed on a local basis, taking into account the local infrastructure and available resources. ", doi="10.2196/27073", url="https://cancer.jmir.org/2021/4/e27073", url="http://www.ncbi.nlm.nih.gov/pubmed/34726611" } @Article{info:doi/10.2196/24936, author="AlShehry, Faiez Nawal and Shanker, Raja and Zaidi, Ahmed Syed Ziauddin and AlGhmlas, Fahad and Motabi, Hussein Ibraheem and Iqbal, Shahid and Butt, Ali Ahmad and AlShehri, Hassan and Tailor, Khan Imran and Altaf, Yasir Syed and AlGhamdi, Mubarak and Marie, Mohammed and AlFayez, Mansour and Al Zahrani, Kamal and Dwaimah, Mohammed and Al-Halouli, Tahani and Al-Shakweer, Wafaa and AlShehery, Zaher Maied and Zaidi, Zia Abdul Rehman and Gill, Munawar Atta and Albtoosh, Mohammed Belal and Ahmed, Musab", title="Role of 18F-Fluorodeoxyglucose--Positron Emission Tomography/Computed Tomography Imaging in the Prediction of Prognosis in Patients With Indolent Lymphoma: Prospective Study", journal="JMIR Form Res", year="2021", month="Nov", day="12", volume="5", number="11", pages="e24936", keywords="positron emission tomography", keywords="lymphoma", keywords="prognosis", keywords="indolent lymphoma", keywords="SUVmax", keywords="Deauville criteria", abstract="Background: The role of fluorodeoxyglucose--positron emission tomography/computed tomography (FDG-PET/CT) in indolent lymphoma has been minimally studied. Objective: This study aims to assess the value of FDG-PET/CT in predicting the prognosis of indolent lymphoma. Methods: We prospectively recruited 42 patients with indolent lymphoma. A total of 2 patients were excluded, and 40 underwent baseline PET/CT and follow-up at various time points. A total of 9 patients were observed only, 7 received 4 doses of rituximab alone, and 24 received chemoimmunotherapy. Metabolic response on follow-up PET/CT was assessed using the maximum standardized uptake value (SUVmax) and Deauville criteria (DC). We aimed to obtain the best SUVmax and DC to predict optimal survival rates, risk stratification, and optimize therapeutic strategies. The mean follow-up from the initial diagnosis was 33.83 months. Results: SUVmax <4.35 at interim PET/CT provided the best discrimination, with a progression-free survival (PFS) of 100\% and a median survival time of 106.67 months compared with SUVmax ?4.35 (P=.04), which had a PFS of 43.8\% and a median survival time of 50.17 months. This cutoff was also valuable in predicting overall survival at baseline, that is, 100\% overall survival with baseline SUVmax <4.35, versus 58.4\% for SUVmax ?4.35 (P=.13). The overall survival of patients with a baseline DC score <3.0 was 100\%, with a median overall survival of 106.67 months. Conclusions: We demonstrated the utility of PET/CT in indolent lymphomas. SUVmax (<4.35 vs ?4.35) on interim PET/CT performed best in predicting PFS. ", doi="10.2196/24936", url="https://formative.jmir.org/2021/11/e24936", url="http://www.ncbi.nlm.nih.gov/pubmed/34508363" } @Article{info:doi/10.2196/32395, author="Marron, Manuela and Brackmann, Kim Lara and Schwarz, Heike and Hummel-Bartenschlager, Willempje and Zahnreich, Sebastian and Galetzka, Danuta and Schmitt, Iris and Grad, Christian and Drees, Philipp and Hopf, Johannes and Mirsch, Johanna and Scholz-Kreisel, Peter and Kaatsch, Peter and Poplawski, Alicia and Hess, Moritz and Binder, Harald and Hankeln, Thomas and Blettner, Maria and Schmidberger, Heinz", title="Identification of Genetic Predispositions Related to Ionizing Radiation in Primary Human Skin Fibroblasts From Survivors of Childhood and Second Primary Cancer as Well as Cancer-Free Controls: Protocol for the Nested Case-Control Study KiKme", journal="JMIR Res Protoc", year="2021", month="Nov", day="11", volume="10", number="11", pages="e32395", keywords="fibroblast", keywords="irradiation", keywords="childhood cancer", keywords="neoplasm", keywords="second primary neoplasm", keywords="second cancer", keywords="study design", keywords="participation", keywords="feasibility", keywords="cell line", abstract="Background: Therapy for a first primary neoplasm (FPN) in childhood with high doses of ionizing radiation is an established risk factor for second primary neoplasms (SPN). An association between exposure to low doses and childhood cancer is also suggested; however, results are inconsistent. As only subgroups of children with FPNs develop SPNs, an interaction between radiation, genetic, and other risk factors is presumed to influence cancer development. Objective: Therefore, the population-based, nested case-control study KiKme aims to identify differences in genetic predisposition and radiation response between childhood cancer survivors with and without SPNs as well as cancer-free controls. Methods: We conducted a population-based, nested case-control study KiKme. Besides questionnaire information, skin biopsies and saliva samples are available. By measuring individual reactions to different exposures to radiation (eg, 0.05 and 2 Gray) in normal somatic cells of the same person, our design enables us to create several exposure scenarios for the same person simultaneously and measure several different molecular markers (eg, DNA, messenger RNA, long noncoding RNA, copy number variation). Results: Since 2013, 101 of 247 invited SPN patients, 340 of 1729 invited FPN patients, and 150 of 246 invited cancer-free controls were recruited and matched by age and sex. Childhood cancer patients were additionally matched by tumor morphology, year of diagnosis, and age at diagnosis. Participants reported on lifestyle, socioeconomical, and anthropometric factors, as well as on medical radiation history, health, and family history of diseases (n=556). Primary human fibroblasts from skin biopsies of the participants were cultivated (n=499) and cryopreserved (n=3886). DNA was extracted from fibroblasts (n=488) and saliva (n=510). Conclusions: This molecular-epidemiological study is the first to combine observational epidemiological research with standardized experimental components in primary human skin fibroblasts to identify genetic predispositions related to ionizing radiation in childhood and SPNs. In the future, fibroblasts of the participants will be used for standardized irradiation experiments, which will inform analysis of the case-control study and vice versa. Differences between participants will be identified using several molecular markers. With its innovative combination of experimental and observational components, this new study will provide valuable data to forward research on radiation-related risk factors in childhood cancer and SPNs. International Registered Report Identifier (IRRID): DERR1-10.2196/32395 ", doi="10.2196/32395", url="https://www.researchprotocols.org/2021/11/e32395", url="http://www.ncbi.nlm.nih.gov/pubmed/34762066" } @Article{info:doi/10.2196/19812, author="Liang, Chia-Wei and Yang, Hsuan-Chia and Islam, Mohaimenul Md and Nguyen, Alex Phung Anh and Feng, Yi-Ting and Hou, Yu Ze and Huang, Chih-Wei and Poly, Nasrin Tahmina and Li, Jack Yu-Chuan", title="Predicting Hepatocellular Carcinoma With Minimal Features From Electronic Health Records: Development of a Deep Learning Model", journal="JMIR Cancer", year="2021", month="Oct", day="28", volume="7", number="4", pages="e19812", keywords="hepatocellular carcinoma", keywords="deep learning", keywords="risk prediction", keywords="convolution neural network", keywords="deep learning model", keywords="hepatoma", abstract="Background: Hepatocellular carcinoma (HCC), usually known as hepatoma, is the third leading cause of cancer mortality globally. Early detection of HCC helps in its treatment and increases survival rates. Objective: The aim of this study is to develop a deep learning model, using the trend and severity of each medical event from the electronic health record to accurately predict the patients who will be diagnosed with HCC in 1 year. Methods: Patients with HCC were screened out from the National Health Insurance Research Database of Taiwan between 1999 and 2013. To be included, the patients with HCC had to register as patients with cancer in the catastrophic illness file and had to be diagnosed as a patient with HCC in an inpatient admission. The control cases (non-HCC patients) were randomly sampled from the same database. We used age, gender, diagnosis code, drug code, and time information as the input variables of a convolution neural network model to predict those patients with HCC. We also inspected the highly weighted variables in the model and compared them to their odds ratio at HCC to understand how the predictive model works Results: We included 47,945 individuals, 9553 of whom were patients with HCC. The area under the receiver operating curve (AUROC) of the model for predicting HCC risk 1 year in advance was 0.94 (95\% CI 0.937-0.943), with a sensitivity of 0.869 and a specificity 0.865. The AUROC for predicting HCC patients 7 days, 6 months, 1 year, 2 years, and 3 years early were 0.96, 0.94, 0.94, 0.91, and 0.91, respectively. Conclusions: The findings of this study show that the convolutional neural network model has immense potential to predict the risk of HCC 1 year in advance with minimal features available in the electronic health records. ", doi="10.2196/19812", url="https://cancer.jmir.org/2021/4/e19812", url="http://www.ncbi.nlm.nih.gov/pubmed/34709180" } @Article{info:doi/10.2196/26425, author="George, Mathew and Smith, Alexandra and Sabesan, Sabe and Ranmuthugala, Geetha", title="Physical Comorbidities and Their Relationship with Cancer Treatment and Its Outcomes in Older Adult Populations: Systematic Review", journal="JMIR Cancer", year="2021", month="Oct", day="13", volume="7", number="4", pages="e26425", keywords="comorbidities", keywords="cancer", keywords="chemotherapy", keywords="geriatric", keywords="quality of life", keywords="morbidity", keywords="treatment", keywords="older adults", keywords="review", abstract="Background: Cancer is one of the predominant causes of morbidity and mortality in older adult populations worldwide. Among a range of barriers, comorbidity particularly poses a clinical challenge in cancer diagnosis, prognosis, and treatment owing to its heterogeneous nature. While accurate comorbidity assessments and appropriate treatment administration can result in better patient outcomes, evidence related to older adult cancer populations is limited as these individuals are often excluded from regular clinical trials due to age and comorbid conditions. Objective: To determine the prevalence of physical comorbidity and the impact of physical comorbidities and rurality on treatment and its outcomes in older adult cancer populations. Methods: Scientific databases Embase and PubMed were searched for published scientific literature on physical comorbidity and older adult cancer patients. Google Scholar was searched for scholarly literature published in nonindexed journals. Snowballing was utilized to identify research papers missed in the above searches. Included studies : (1) reported on original research involving cancer patients; (2) included patients aged 65 years or older; (3) had patients receiving cancer-related treatment and (4) cancer survivors; (5) reported on physical comorbidity as a variable; (6) were published in English; and (7) conducted from any geographical location. Results: In total, 29 studies were selected for data extraction, evidence synthesis, and quality assessment. In these, comorbidities ranged from 37.9\%-74.3\% in colorectal cancer, 74\%-81\% in head and neck cancer, and 12.6\%-49\% in breast cancer. Moderate comorbidities ranged from 13\%-72.9\%, and severe comorbidities from 2.5\%-68.2\%. Comorbidity increased with age, with comorbidity affecting both treatment choice and process. Physical comorbidities significantly affected treatment initiation, causing delay, toxicity, and discontinuation. Older adult cancer patients were given less vigorous and nonstandard treatments and were also less likely to be offered treatment. Where patients are given more vigorous treatment, several studies showed better survival outcomes. Appropriate treatment in older adult cancer patients increased both overall and disease-related survival rates. None of the studies noted rurality as a distinct variable. Conclusions: This systematic review concludes that there is evidence to substantiate the adverse effect of comorbidity on treatment and survival outcomes. However, the mechanism by which comorbidity impedes or impacts treatment is unknown in many cases. Some low-quality evidence is available for considering the functional status and biological age in treatment decisions. Future studies that substantiate the value of comprehensive older adult assessments before treatment initiation in cancer patients, including assessing the nature and severity of comorbidities, and additional consideration of rurality as a factor, could lessen the effect of comorbidities on the treatment process. ", doi="10.2196/26425", url="https://cancer.jmir.org/2021/4/e26425", url="http://www.ncbi.nlm.nih.gov/pubmed/34643534" } @Article{info:doi/10.2196/31150, author="Alshammari, O. Fatemah O. F. and Al-saraireh, M. Yousef and Youssef, M. Ahmed M. and Al-Sarayra, M. Yahya and Alrawashdeh, Mohammad Hamzeh", title="Cytochrome P450 1B1 Overexpression in Cervical Cancers: Cross-sectional Study", journal="Interact J Med Res", year="2021", month="Oct", day="12", volume="10", number="4", pages="e31150", keywords="cancer", keywords="cervical cancer", keywords="cytochrome P450", keywords="cytochrome 1B1", keywords="immunohistochemistry", keywords="toxicity", keywords="therapies", keywords="molecular", keywords="tumor", keywords="cytochrome", keywords="cervix", abstract="Background: Current standard treatments for patients with recurrent cervical cancer are not very effective and are associated with severe toxicity. Recently, the rational approach for the discovery of new therapies for cervical cancer is based on the alterations in the molecular biology of cancer cells. One of the emerging molecular changes in cancer cells is the aberrant expression of cytochrome P450 1B1 (CYP1B1). This unique enzyme has been reported to be selectively overexpressed in several cancers. Objective: The aim of this study was to examine CYP1B1 expression in cervical cancers and to assess the enzyme's relationship with several clinicopathological features. Methods: Immunohistochemistry was performed to examine CYP1B1 expression in 100 patient samples with cervical cancer and 10 patient samples with normal healthy cervical tissues. Results: CYP1B1 was expressed in the majority of the cervical cancer samples (91/100, 91.0\%) but not in normal healthy cervical samples. The difference in the expression of CYP1B1 between healthy and tumorous cervical tissues was significant (P=.01). Moreover, the frequency of CYP1B1 expression was found to be significantly higher in patients with advanced grades of the disease (P=.03) and in patients having metastasis to the lymph nodes (P=.01). Surprisingly, there was a significantly higher expression of CYP1B1 in patients with a high prevalence of human papilloma virus 16/18 (P=.04). Conclusions: The differential profile of CYP1B1 expression between cervical cancer tissues and normal cervical tissues suggests that CYP1B1 may be used as a target for future therapeutic exploitations. ", doi="10.2196/31150", url="https://www.i-jmr.org/2021/4/e31150", url="http://www.ncbi.nlm.nih.gov/pubmed/34636736" } @Article{info:doi/10.2196/29123, author="Naeim, Arash and Dry, Sarah and Elashoff, David and Xie, Zhuoer and Petruse, Antonia and Magyar, Clara and Johansen, Liliana and Werre, Gabriela and Lajonchere, Clara and Wenger, Neil", title="Electronic Video Consent to Power Precision Health Research: A Pilot Cohort Study", journal="JMIR Form Res", year="2021", month="Sep", day="8", volume="5", number="9", pages="e29123", keywords="biobanking", keywords="precision medicine", keywords="electronic consent", keywords="privacy", keywords="pilot study", keywords="video", keywords="consent", keywords="precision", keywords="innovation", keywords="efficient", keywords="cancer", keywords="education", keywords="barrier", keywords="engagement", keywords="participation", abstract="Background: Developing innovative, efficient, and institutionally scalable biospecimen consent for remnant tissue that meets the National Institutes of Health consent guidelines for genomic and molecular analysis is essential for precision medicine efforts in cancer. Objective: This study aims to pilot-test an electronic video consent that individuals could complete largely on their own. Methods: The University of California, Los Angeles developed a video consenting approach designed to be comprehensive yet fast (around 5 minutes) for providing universal consent for remnant biospecimen collection for research. The approach was piloted in 175 patients who were coming in for routine services in laboratory medicine, radiology, oncology, and hospital admissions. The pilot yielded 164 completed postconsent surveys. The pilot assessed the usefulness, ease, and trustworthiness of the video consent. In addition, we explored drivers for opting in or opting out. Results: The pilot demonstrated that the electronic video consent was well received by patients, with high scores for usefulness, ease, and trustworthiness even among patients that opted out of participation. The revised more animated video pilot test in phase 2 was better received in terms of ease of use (P=.005) and the ability to understand the information (P<.001). There were significant differences between those who opted in and opted out in their beliefs concerning the usefulness of tissue, trusting researchers, the importance of contributing to science, and privacy risk (P<.001). The results showed that ``I trust researchers to use leftover biological specimens to promote the public's health'' and ``Sharing a biological sample for research is safe because of the privacy protections in place'' discriminated opt-in statuses were the strongest predictors (both areas under the curve were 0.88). Privacy concerns seemed universal in individuals who opted out. Conclusions: Efforts to better educate the community may be needed to help overcome some of the barriers in engaging individuals to participate in precision health initiatives. ", doi="10.2196/29123", url="https://formative.jmir.org/2021/9/e29123", url="http://www.ncbi.nlm.nih.gov/pubmed/34313247" } @Article{info:doi/10.2196/25789, author="Wang, Quan and Yang, Ke-Lu and Zhang, Zhen and Wang, Zhu and Li, Chen and Li, Lun and Tian, Jin-Hui and Ye, Ying-Jiang and Wang, Shan and Jiang, Ke-Wei", title="Characterization of Global Research Trends and Prospects on Single-Cell Sequencing Technology: Bibliometric Analysis", journal="J Med Internet Res", year="2021", month="Aug", day="10", volume="23", number="8", pages="e25789", keywords="single-cell sequencing", keywords="bibliometric analysis", keywords="cancer", keywords="cancer genomics", keywords="bioinformatics", keywords="cancer subtyping", keywords="tumor dissociation", keywords="tumor microenvironment", keywords="precision medicine", keywords="immunology", keywords="development trends", keywords="hotspots", keywords="research topics", keywords="Web of Science", keywords="CiteSpace", keywords="VOSviewer", keywords="network", abstract="Background: As single-cell sequencing technology has been gradually introduced, it is essential to characterize global collaboration networks and map development trends over the past 20 years. Objective: The aim of this paper was to illustrate collaboration in the field of single-cell sequencing methods and explore key topics and future directions. Methods: Bibliometric analyses were conducted with CiteSpace and VOSviewer software on publications prior to November 2019 from the Web of Science Core Collection about single-cell sequencing methods. Results: Ultimately, we identified 2489 records, which were published in 495 journals by 14,202 authors from 1970 institutes in 61 countries. There was a noticeable increase in publications in 2014. The United States and high-income countries in Europe contributed to most of the records included. Harvard University, Stanford University, Karolinska Institutes, Peking University, and the University of Washington were the biggest nodes in every cluster of the collaboration network, and SA Teichmann, JC Marioni, A Regev, and FC Tang were the top-producing authors. Keywords co-occurrence analysis suggested applications in immunology as a developing research trend. Conclusions: We concluded that the global collaboration network was unformed and that high-income countries contributed more to the rapidly growth of publications of single-cell sequencing technology. Furthermore, the application in immunology might be the next research hotspot and developmental direction. ", doi="10.2196/25789", url="https://www.jmir.org/2021/8/e25789", url="http://www.ncbi.nlm.nih.gov/pubmed/34014832" } @Article{info:doi/10.2196/27110, author="Zhao, Ziran and Cheng, Xi and Sun, Xiao and Ma, Shanrui and Feng, Hao and Zhao, Liang", title="Prediction Model of Anastomotic Leakage Among Esophageal Cancer Patients After Receiving an Esophagectomy: Machine Learning Approach", journal="JMIR Med Inform", year="2021", month="Jul", day="27", volume="9", number="7", pages="e27110", keywords="anastomotic leakage", keywords="esophageal cancer", keywords="esophagectomy", keywords="machine learning", keywords="risk factors", abstract="Background: Anastomotic leakage (AL) is one of the severe postoperative adverse events (5\%-30\%), and it is related to increased medical costs in cancer patients who undergo esophagectomies. Machine learning (ML) methods show good performance at predicting risk for AL. However, AL risk prediction based on ML models among the Chinese population is unavailable. Objective: This study uses ML techniques to develop and validate a risk prediction model to screen patients with emerging AL risk factors. Methods: Analyses were performed using medical records from 710 patients who underwent esophagectomies at the National Clinical Research Center for Cancer between January 2010 and May 2015. We randomly split (9:1) the data set into a training data set of 639 patients and a testing data set of 71 patients using a computer algorithm. We assessed multiple classification tools to create a multivariate risk prediction model. Our ML algorithms contained decision tree, random forest, naive Bayes, and logistic regression with least absolute shrinkage and selection operator. The optimal AL prediction model was selected based on model evaluation metrics. Results: The final risk panel included 36 independent risk features. Of those, 10 features were significantly identified by the logistic model, including aortic calcification (OR 2.77, 95\% CI 1.32-5.81), celiac trunk calcification (OR 2.79, 95\% CI 1.20-6.48), forced expiratory volume 1\% (OR 0.51, 95\% CI 0.30-0.89); TLco (OR 0.56, 95\% CI 0.27-1.18), peripheral vascular disease (OR 4.97, 95\% CI 1.44-17.07), laparoscope (OR 3.92, 95\% CI 1.23-12.51), postoperative length of hospital stay (OR 1.17, 95\% CI 1.13-1.21), vascular permeability activity (OR 0.46, 95\% CI 0.14-1.48), and fat liquefaction of incisions (OR 4.36, 95\% CI 1.86-10.21). Logistic regression with least absolute shrinkage and selection operator offered the highest prediction quality with an area under the receiver operator characteristic of 72\% in the training data set. The testing model also achieved similar high performance. Conclusions: Our model offered a prediction of AL with high accuracy, assisting in AL prevention and treatment. A personalized ML prediction model with a purely data-driven selection of features is feasible and effective in predicting AL in patients who underwent esophagectomy. ", doi="10.2196/27110", url="https://medinform.jmir.org/2021/7/e27110", url="http://www.ncbi.nlm.nih.gov/pubmed/34313597" } @Article{info:doi/10.2196/24423, author="Li, Guorong and Mallouk, Nora and Flandrin, Pascale and Garcin, Arnauld and Lambert, Claude and Berremila, Ali Sid and Habchi, Hocine and Mottet, Nicolas", title="Presence of Urinary Exosomes for Liquid Biopsy of Clear Cell Renal Cell Carcinoma: Protocol for a Pilot Feasibility Study", journal="JMIR Res Protoc", year="2021", month="Jul", day="20", volume="10", number="7", pages="e24423", keywords="liquid biopsy", keywords="urine exosome", keywords="CA9", keywords="clear cell renal cell carcinoma", keywords="kidney cancer", abstract="Background: Approximately 70\%-80\% of kidney cancers are clear cell renal cell carcinomas (CCRCCs). Patient management is based on imaging (abdominal ultrasound and computerized tomography), surgical excision of the tumor, and pathological analysis. A tissue biopsy is therefore necessary to confirm the diagnosis and avoid unnecessary nephrectomy. For metastatic cancers, a tissue biopsy is essential for establishing the targeted therapy. This biopsy of tumor material is invasive and painful. Other techniques such as liquid biopsy would help reduce the need for tissue biopsy. The development of a simple biological test for diagnosis is essential. CA9 is a powerful marker for the diagnosis of CCRCC. Exosomes have become a major source of liquid biopsy because they carry tumor proteins, RNA, and lipids. Urine is the most convenient biological liquid for exosome sampling. Objective: The aim of this study (PEP-C study) is mainly to determine whether it is possible to detect urinary exosomal CA9 for the molecular diagnosis of CCRCC. Methods: This study will include 60 patients with CCRCC and 40 noncancer patients. Exosomes will be isolated from urine samples and exosomal CA9 will be detected by transmission electron microscopy, flow cytometry, and reverse transcription-quantitative polymerase chain reaction. Results: This study is currently underway with funding support from the CHU Saint-Etienne of France. Conclusions: We expect to demonstrate that urinary tumor exosomes could be a novel liquid biopsy to diagnose CCRCC and to guide clinicians in treatment decision-making. Trial Registration: ClinicalTrials.gov NCT04053855; https://clinicaltrials.gov/ct2/show/NCT04053855 International Registered Report Identifier (IRRID): DERR1-10.2196/24423 ", doi="10.2196/24423", url="https://www.researchprotocols.org/2021/7/e24423", url="http://www.ncbi.nlm.nih.gov/pubmed/34283029" } @Article{info:doi/10.2196/27767, author="Haddad, Tufia and Helgeson, M. Jane and Pomerleau, E. Katharine and Preininger, M. Anita and Roebuck, Christopher M. and Dankwa-Mullan, Irene and Jackson, Purcell Gretchen and Goetz, P. Matthew", title="Accuracy of an Artificial Intelligence System for Cancer Clinical Trial Eligibility Screening: Retrospective Pilot Study", journal="JMIR Med Inform", year="2021", month="Mar", day="26", volume="9", number="3", pages="e27767", keywords="clinical trial matching", keywords="clinical decision support system", keywords="machine learning", keywords="artificial intelligence", keywords="screening", keywords="clinical trials", keywords="eligibility", keywords="breast cancer", abstract="Background: Screening patients for eligibility for clinical trials is labor intensive. It requires abstraction of data elements from multiple components of the longitudinal health record and matching them to inclusion and exclusion criteria for each trial. Artificial intelligence (AI) systems have been developed to improve the efficiency and accuracy of this process. Objective: This study aims to evaluate the ability of an AI clinical decision support system (CDSS) to identify eligible patients for a set of clinical trials. Methods: This study included the deidentified data from a cohort of patients with breast cancer seen at the medical oncology clinic of an academic medical center between May and July 2017 and assessed patient eligibility for 4 breast cancer clinical trials. CDSS eligibility screening performance was validated against manual screening. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value for eligibility determinations were calculated. Disagreements between manual screeners and the CDSS were examined to identify sources of discrepancies. Interrater reliability between manual reviewers was analyzed using Cohen (pairwise) and Fleiss (three-way) $\kappa$, and the significance of differences was determined by Wilcoxon signed-rank test. Results: In total, 318 patients with breast cancer were included. Interrater reliability for manual screening ranged from 0.60-0.77, indicating substantial agreement. The overall accuracy of breast cancer trial eligibility determinations by the CDSS was 87.6\%. CDSS sensitivity was 81.1\% and specificity was 89\%. Conclusions: The AI CDSS in this study demonstrated accuracy, sensitivity, and specificity of greater than 80\% in determining the eligibility of patients for breast cancer clinical trials. CDSSs can accurately exclude ineligible patients for clinical trials and offer the potential to increase screening efficiency and accuracy. Additional research is needed to explore whether increased efficiency in screening and trial matching translates to improvements in trial enrollment, accruals, feasibility assessments, and cost. ", doi="10.2196/27767", url="https://medinform.jmir.org/2021/3/e27767", url="http://www.ncbi.nlm.nih.gov/pubmed/33769304" } @Article{info:doi/10.2196/19408, author="Smit, A. Marloes and van Pelt, W. Gabi and Dequeker, MC Elisabeth and Al Dieri, Raed and Tollenaar, AEM Rob and van Krieken, JM J. Han and Mesker, E. Wilma and ", title="e-Learning for Instruction and to Improve Reproducibility of Scoring Tumor-Stroma Ratio in Colon Carcinoma: Performance and Reproducibility Assessment in the UNITED Study", journal="JMIR Form Res", year="2021", month="Mar", day="19", volume="5", number="3", pages="e19408", keywords="colon cancer", keywords="tumor-stroma ratio", keywords="validation", keywords="e-Learning", keywords="reproducibility study", keywords="cancer", keywords="tumor", keywords="colon", keywords="reproducibility", keywords="carcinoma", keywords="prognosis", keywords="diagnostic", keywords="implementation", keywords="online learning", abstract="Background: The amount of stroma in the primary tumor is an important prognostic parameter. The tumor-stroma ratio (TSR) was previously validated by international research groups as a robust parameter with good interobserver agreement. Objective: The Uniform Noting for International Application of the Tumor-Stroma Ratio as an Easy Diagnostic Tool (UNITED) study was developed to bring the TSR to clinical implementation. As part of the study, an e-Learning module was constructed to confirm the reproducibility of scoring the TSR after proper instruction. Methods: The e-Learning module consists of an autoinstruction for TSR determination (instruction video or written protocol) and three sets of 40 cases (training, test, and repetition sets). Scoring the TSR is performed on hematoxylin and eosin--stained sections and takes only 1-2 minutes. Cases are considered stroma-low if the amount of stroma is ?50\%, whereas a stroma-high case is defined as >50\% stroma. Inter- and intraobserver agreements were determined based on the Cohen $\kappa$ score after each set to evaluate the reproducibility. Results: Pathologists and pathology residents (N=63) with special interest in colorectal cancer participated in the e-Learning. Forty-nine participants started the e-Learning and 31 (63\%) finished the whole cycle (3 sets). A significant improvement was observed from the training set to the test set; the median $\kappa$ score improved from 0.72 to 0.77 (P=.002). Conclusions: e-Learning is an effective method to instruct pathologists and pathology residents for scoring the TSR. The reliability of scoring improved from the training to the test set and did not fall back with the repetition set, confirming the reproducibility of the TSR scoring method. Trial Registration: The Netherlands Trial Registry NTR7270; https://www.trialregister.nl/trial/7072 International Registered Report Identifier (IRRID): RR2-10.2196/13464 ", doi="10.2196/19408", url="https://formative.jmir.org/2021/3/e19408", url="http://www.ncbi.nlm.nih.gov/pubmed/33739293" } @Article{info:doi/10.2196/21401, author="Yang, Hsuan-Chia and Islam, Mohaimenul Md and Nguyen, Alex Phung Anh and Wang, Ching-Huan and Poly, Nasrin Tahmina and Huang, Chih-Wei and Li, Jack Yu-Chuan", title="Development of a Web-Based System for Exploring Cancer Risk With Long-term Use of Drugs: Logistic Regression Approach", journal="JMIR Public Health Surveill", year="2021", month="Feb", day="15", volume="7", number="2", pages="e21401", keywords="cancer", keywords="risk", keywords="prevention", keywords="chemoprevention", keywords="long-term--use drugs", keywords="drug", keywords="epidemiology", keywords="temporal model", keywords="modeling", keywords="web-based system", abstract="Background: Existing epidemiological evidence regarding the association between the long-term use of drugs and cancer risk remains controversial. Objective: We aimed to have a comprehensive view of the cancer risk of the long-term use of drugs. Methods: A nationwide population-based, nested, case-control study was conducted within the National Health Insurance Research Database sample cohort of 1999 to 2013 in Taiwan. We identified cases in adults aged 20 years and older who were receiving treatment for at least two months before the index date. We randomly selected control patients from the patients without a cancer diagnosis during the 15 years (1999-2013) of the study period. Case and control patients were matched 1:4 based on age, sex, and visit date. Conditional logistic regression was used to estimate the association between drug exposure and cancer risk by adjusting potential confounders such as drugs and comorbidities. Results: There were 79,245 cancer cases and 316,980 matched controls included in this study. Of the 45,368 associations, there were 2419, 1302, 662, and 366 associations found statistically significant at a level of P<.05, P<.01, P<.001, and P<.0001, respectively. Benzodiazepine derivatives were associated with an increased risk of brain cancer (adjusted odds ratio [AOR] 1.379, 95\% CI 1.138-1.670; P=.001). Statins were associated with a reduced risk of liver cancer (AOR 0.470, 95\% CI 0.426-0.517; P<.0001) and gastric cancer (AOR 0.781, 95\% CI 0.678-0.900; P<.001). Our web-based system, which collected comprehensive data of associations, contained 2 domains: (1) the drug and cancer association page and (2) the overview page. Conclusions: Our web-based system provides an overview of comprehensive quantified data of drug-cancer associations. With all the quantified data visualized, the system is expected to facilitate further research on cancer risk and prevention, potentially serving as a stepping-stone to consulting and exploring associations between the long-term use of drugs and cancer risk. ", doi="10.2196/21401", url="http://publichealth.jmir.org/2021/2/e21401/", url="http://www.ncbi.nlm.nih.gov/pubmed/33587043" } @Article{info:doi/10.2196/21931, author="Lin, Min-Qiang and Lian, Chen-Lu and Zhou, Ping and Lei, Jian and Wang, Jun and Hua, Li and Zhou, Juan and Wu, San-Gang", title="Analysis of the Trends in Publications on Clinical Cancer Research in Mainland China from the Surveillance, Epidemiology, and End Results (SEER) Database: Bibliometric Study", journal="JMIR Med Inform", year="2020", month="Nov", day="17", volume="8", number="11", pages="e21931", keywords="cancer", keywords="China", keywords="data collection", keywords="bibliometrics", keywords="PubMed", keywords="SEER program", abstract="Background: The application of China's big data sector in cancer research is just the beginning. In recent decades, more and more Chinese scholars have used the Surveillance, Epidemiology, and End Results (SEER) database for clinical cancer research. A comprehensive bibliometric study is required to analyze the tendency of Chinese scholars to utilize the SEER database for clinical cancer research and provide a reference for the future of big data analytics. Objective: Our study aimed to assess the trend of publications on clinical cancer research in mainland China from the SEER database. Methods: We performed a PubMed search to identify papers published with data from the SEER database in mainland China until August 31, 2020. Results: A total of 1566 papers utilizing the SEER database that were authored by investigators in mainland China were identified. Over the past years, significant growth in studies based on the SEER database was observed (P<.001). The top 5 research topics were breast cancer (213/1566, 13.6\%), followed by colorectal cancer (185/1566, 11.8\%), lung cancer (179/1566, 11.4\%), gastrointestinal cancer (excluding colorectal cancer; 149/1566, 9.5\%), and genital system cancer (93/1566, 5.9\%). Approximately 75.2\% (1178/1566) of papers were published from the eastern coastal region of China, and Fudan University Shanghai Cancer Center (Shanghai, China) was the most active organization. Overall, 267 journals were analyzed in this study, of which Oncotarget was the most contributing journal (136/267, 50.9\%). Of the 1566 papers studied, 585 (37.4\%) were published in the second quartile, 489 (31.2\%) in the third quartile, 312 (19.9\%) in the first quartile, and 80 (5.1\%) in the fourth quartile, with 100 (6.4\%) having an unknown Journal Citation Reports ranking. Conclusions: Clinical cancer research based on the SEER database in mainland China underwent constant and rapid growth during recent years. High-quality and comprehensive cancer databases based on Chinese demographic data are urgently needed. ", doi="10.2196/21931", url="http://medinform.jmir.org/2020/11/e21931/", url="http://www.ncbi.nlm.nih.gov/pubmed/33200992" } @Article{info:doi/10.2196/17524, author="Sasada, Shinsuke and Masumoto, Norio and Song, Hang and Emi, Akiko and Kadoya, Takayuki and Arihiro, Koji and Kikkawa, Takamaro and Okada, Morihito", title="Microwave Breast Imaging Using Rotational Bistatic Impulse Radar for the Detection of Breast Cancer: Protocol for a Prospective Diagnostic Study", journal="JMIR Res Protoc", year="2020", month="Oct", day="19", volume="9", number="10", pages="e17524", keywords="breast cancer", keywords="microwave imaging", keywords="diagnostic accuracy", keywords="screening", keywords="ultra-wideband radar", abstract="Background: Mammography is the standard examination for breast cancer screening; however, it is associated with pain and exposure to ionizing radiation. Microwave breast imaging is a less invasive method for breast cancer surveillance. A bistatic impulse radar--based breast cancer detector has recently been developed. Objective: This study aims to present a protocol for evaluating the diagnostic accuracy of the novel microwave breast imaging device. Methods: This is a prospective diagnostic study. A total of 120 participants were recruited before treatment administration and divided into 2 cohorts: 100 patients diagnosed with breast cancer and 20 participants with benign breast tumors. The detector will be directly placed on each breast, while the participant is in supine position, without a coupling medium. Confocal images will be created based on the analyzed data, and the presence of breast tumors will be assessed. The primary endpoint will be the diagnostic accuracy, sensitivity, and specificity of the detector for breast cancer and benign tumors. The secondary endpoint will be the safety and detectability of each molecular subtype of breast cancer. For an exploratory endpoint, the influence of breast density and tumor size on tumor detection will be investigated. Results: Recruitment began in November 2018 and was completed by March 2020. We anticipate the preliminary results to be available by summer 2021. Conclusions: This study will provide insights on the diagnostic accuracy of microwave breast imaging using a rotational bistatic impulse radar. The collected data will improve the diagnostic algorithm of microwave imaging and lead to enhanced device performance. Trial Registration: Japan Registry of Clinical Trials jRCTs062180005; https://jrct.niph.go.jp/en-latest-detail/jRCTs062180005 International Registered Report Identifier (IRRID): DERR1-10.2196/17524 ", doi="10.2196/17524", url="http://www.researchprotocols.org/2020/10/e17524/", url="http://www.ncbi.nlm.nih.gov/pubmed/33074156" } @Article{info:doi/10.2196/20836, author="LeBaron, Virginia and Bennett, Rachel and Alam, Ridwan and Blackhall, Leslie and Gordon, Kate and Hayes, James and Homdee, Nutta and Jones, Randy and Martinez, Yudel and Ogunjirin, Emmanuel and Thomas, Tanya and Lach, John", title="Understanding the Experience of Cancer Pain From the Perspective of Patients and Family Caregivers to Inform Design of an In-Home Smart Health System: Multimethod Approach", journal="JMIR Form Res", year="2020", month="Aug", day="26", volume="4", number="8", pages="e20836", keywords="cancer", keywords="pain", keywords="sensors", keywords="smart health", keywords="caregiver", keywords="home based", keywords="palliative care", keywords="opioids", keywords="smart watch", abstract="Background: Inadequately managed pain is a serious problem for patients with cancer and those who care for them. Smart health systems can help with remote symptom monitoring and management, but they must be designed with meaningful end-user input. Objective: This study aims to understand the experience of managing cancer pain at home from the perspective of both patients and family caregivers to inform design of the Behavioral and Environmental Sensing and Intervention for Cancer (BESI-C) smart health system. Methods: This was a descriptive pilot study using a multimethod approach. Dyads of patients with cancer and difficult pain and their primary family caregivers were recruited from an outpatient oncology clinic. The participant interviews consisted of (1) open-ended questions to explore the overall experience of cancer pain at home, (2) ranking of variables on a Likert-type scale (0, no impact; 5, most impact) that may influence cancer pain at home, and (3) feedback regarding BESI-C system prototypes. Qualitative data were analyzed using a descriptive approach to identity patterns and key themes. Quantitative data were analyzed using SPSS; basic descriptive statistics and independent sample t tests were run. Results: Our sample (n=22; 10 patient-caregiver dyads and 2 patients) uniformly described the experience of managing cancer pain at home as stressful and difficult. Key themes included (1) unpredictability of pain episodes; (2) impact of pain on daily life, especially the negative impact on sleep, activity, and social interactions; and (3) concerns regarding medications. Overall, taking pain medication was rated as the category with the highest impact on a patient's pain (=4.79), followed by the categories of wellness (=3.60; sleep quality and quantity, physical activity, mood and oral intake) and interaction (=2.69; busyness of home, social or interpersonal interactions, physical closeness or proximity to others, and emotional closeness and connection to others). The category related to environmental factors (temperature, humidity, noise, and light) was rated with the lowest overall impact (=2.51). Patients and family caregivers expressed receptivity to the concept of BESI-C and reported a preference for using a wearable sensor (smart watch) to capture data related to the abrupt onset of difficult cancer pain. Conclusions: Smart health systems to support cancer pain management should (1) account for the experience of both the patient and the caregiver, (2) prioritize passive monitoring of physiological and environmental variables to reduce burden, and (3) include functionality that can monitor and track medication intake and efficacy; wellness variables, such as sleep quality and quantity, physical activity, mood, and oral intake; and levels of social interaction and engagement. Systems must consider privacy and data sharing concerns and incorporate feasible strategies to capture and characterize rapid-onset symptoms. ", doi="10.2196/20836", url="http://formative.jmir.org/2020/8/e20836/", url="http://www.ncbi.nlm.nih.gov/pubmed/32712581" } @Article{info:doi/10.2196/17976, author="Liberale, Gabriel and Vankerckhove, Sophie and Bouazza, Fikri and Gomez Galdon, Maria and Larsimont, Denis and Moreau, Michel and Bourgeois, Pierre and Donckier, Vincent", title="Systemic Sentinel Lymph Node Detection Using Fluorescence Imaging After Indocyanine Green Intravenous Injection in Colorectal Cancer: Protocol for a Feasibility Study", journal="JMIR Res Protoc", year="2020", month="Aug", day="14", volume="9", number="8", pages="e17976", keywords="indocyanine green", keywords="colorectal cancer", keywords="fluorescence imaging", keywords="nodal staging", keywords="sentinel lymph node detection", keywords="cancer", keywords="lymph node", keywords="prognosis", keywords="treatment", abstract="Background: Nodal staging is a major concern in colorectal cancer as it is an important prognostic factor. Several techniques that could potentially improve patient treatment and prognosis have been developed to increase the accuracy of nodal staging. Sentinel lymph node detection has been shown to accurately reflect nodal status in various tumors and has become the standard procedure in nodal staging of breast cancer and melanoma. However, in colorectal cancer, sentinel lymph node detection techniques are still controversial as the sensitivity reported in the literature varies from one study to another. Recently, indocyanine green fluorescence--guided surgery has been reported to be a useful technique for detection of macroscopic and microscopic metastatic deposits in lymph nodes after intravenous administration of indocyanine green dye. However, no studies have focused on the potential role of sentinel lymph node detection after systemic administration of indocyanine green dye, so-called systemic sentinel lymph nodes, or on the correspondence between the identification of the sentinel lymph node by standard local injection techniques and the detection of fluorescent lymph nodes with this new approach. Objective: The aim of this protocol is to validate the concept of sentinel lymph nodes identified by fluorescence imaging after intravenous injection of indocyanine green dye and to compare the sentinel lymph nodes identified by fluorescence imaging with sentinel lymph nodes detected by the standard blue dye technique. Methods: This study (SeLyNoFI; Sentinel Lymph Nodes Fluorescence Imaging) is a diagnostic, single-arm, open-label feasibility study, including patients with colorectal adenocarcinoma with or without metastatic disease who are admitted for elective colorectal resection of the primary tumor. This study evaluates the feasibility of a new approach for improving the accuracy of nodal staging using fluorescence imaging after intravenous administration of indocyanine green dye. Sensitivity, positive predictive value, and accuracy of the classical blue dye technique and of the investigatory fluorescence imaging technique will be calculated. Translational research will be proposed, if applicable. Results: As of June 2020, this study has been registered. Submission for ethical review is planned for September 2020. Conclusions: The potential correlation between the two different approaches to detect sentinel lymph nodes offers new strategies for improving the accuracy of nodal staging in colorectal cancer. This new concept of the systemic sentinel lymph node and a greater understanding of the interactions between systemic sentinel lymph nodes and standard sentinel lymph nodes may provide important information regarding the underlying mechanism of primary tumor lymphatic drainage. The enhanced permeability and retention effect can also play a role in the fluorescence of systemic sentinel lymph nodes, especially if these lymph nodes are inflamed. In this case, we can even imagine that this new technique will highlight more instances of lymph node--positive colorectal cancer. International Registered Report Identifier (IRRID): PRR1-10.2196/17976 ", doi="10.2196/17976", url="http://www.researchprotocols.org/2020/8/e17976/", url="http://www.ncbi.nlm.nih.gov/pubmed/32554370" } @Article{info:doi/10.2196/14476, author="Manojlovich, Milisa and Bedard, Louise and Griggs, J. Jennifer and McBratnie, Michaella and Mendelsohn-Victor, Kari and Friese, R. Christopher", title="Facilitators and Barriers to Recruiting Ambulatory Oncology Practices Into a Large Multisite Study: Mixed Methods Study", journal="JMIR Cancer", year="2020", month="Apr", day="20", volume="6", number="1", pages="e14476", keywords="recruitment activities", keywords="ambulatory care facilities", keywords="health services research", abstract="Background: Practice-based research is essential to generate the data necessary to understand outcomes in ambulatory oncology care. Although there is an increased interest in studying ambulatory oncology care, given the rising patient volumes and complexity in those settings, little guidance is available on how best to recruit ambulatory oncology practices for research. Objective: This paper aimed to describe the facilitators and barriers to recruiting ambulatory oncology practices into a large multisite study. Methods: Using a mixed methods design, we sought to recruit 52 ambulatory oncology practices that have participated in a state-wide quality improvement collaborative for the quantitative phase. We used 4 domains of the Consolidated Framework for Implementation Research (CFIR) to describe facilitators and barriers to recruitment. Results: We successfully recruited 28 of the 52 collaborative-affiliated practices, collecting survey data from 2223 patients and 297 clinicians. Intervention attributes included multimodal outreach and training activities to assure high fidelity to the data collection protocol. The implementation process was enhanced through interactive training and practice-assigned champions responsible for data collection. External context attributes that facilitated practice recruitment included partnership with a quality improvement collaborative and the inclusion of a staff member from the collaborative in our team. Key opinion leaders within each practice who could identify challenges to participation and propose flexible solutions represented internal context attributes. We also reported lessons learned during the recruitment process, which included navigating diverse approaches to human subjects protection policies and understanding that recruitment could be a negotiated process that took longer than anticipated, among others. Conclusions: Our experience provides other researchers with challenges to anticipate and possible solutions for common issues. Using the CFIR as a guide, we identified numerous recruitment barriers and facilitators and devised strategies to enhance recruitment efforts. In conclusion, researchers and clinicians can partner effectively to design and implement research protocols that ultimately benefit patients who are increasingly seeking care in ambulatory practices. ", doi="10.2196/14476", url="http://cancer.jmir.org/2020/1/e14476/", url="http://www.ncbi.nlm.nih.gov/pubmed/32310140" } @Article{info:doi/10.2196/16408, author="George, Mathew and Smith, Alexandra", title="Use of an Abbreviated Geriatric Screening Tool in the Assessment of Older Cancer Patients' Functional Status, Dependency, and Comorbidities: Cross-Sectional Audit and Observations From a Regional Cancer Center in Australia", journal="JMIR Cancer", year="2020", month="Apr", day="7", volume="6", number="1", pages="e16408", keywords="geriatric assessment", keywords="cancer", keywords="elderly", keywords="medical oncology", keywords="Australia", abstract="Background: Malignancies are the leading cause of disease burden in Australia, comprising 19\% of total diseases. Approximately 1 in 4 men and 1 in 6 women die from malignancies by 85 years of age, with patients aged 65 years and older contributing to 58\% of diagnoses and 76\% of cancer mortality. In the context of malignancy-related disease and age-related degeneration, there is a need for comprehensive assessment of older patients to plan for appropriate management and predict prognosis. The utility of available comprehensive geriatric assessment tools has been limited in routine practice because of their time-consuming nature, despite their informing clearer understanding of patients' functional status, better clinical decision making, prevention of unpredictable admissions and emergency department overload, and support services planning. Though there are several promising tools available, there is a lack of literature on tools that can comprehensively assess functional status in an expedited fashion. Objective: This study aimed to document functional status and comorbidities among a geriatric oncology patient cohort attending a regionally located, dedicated cancer care facility, using the completed Adelaide tool assessments. This study documents cohort characteristics, including sociodemographics, malignancy type, and comorbidities. Secondarily, we observed the utility of an abridged functional assessment in the multidisciplinary team (MDT) management of older cancer patients. Methods: The study comprised a facility-based cross-sectional audit of results obtained from a screening tool administered to patients aged 65 years and older and attending an outpatient medical oncology clinic for management of cancer from late 2015 to 2017. Data relating to five domains were collected, including instrumental activities of daily living, activities of daily living, performance status, unintended weight loss, and exhaustion. Sociodemographic and disease-related factors were summarized as frequencies with percentages or mean with SD. Distribution of functional status based on sociodemographic characteristics, living status, disease-related factors, and comorbidities was analyzed using a chi-square test. Cumulative dependencies in the five domains were identified, and patients were classified as fit, vulnerable, or frail. Supplementary review of presentation notes for cases discussed at MDT meetings was undertaken to identify discrepancies. Results: A majority of the study population showed poor functional status, with 88.7\% (243/274) categorized as vulnerable and 8.4\% (23/274) as frail. Exhaustion and unintended weight loss were identified as the most common contributors to dependency. Polypharmacy was strongly associated with decreased functional status. Conclusions: The outcomes of this study are congruent with the existence of dependency in various domains, and with similar research in geriatric oncology. The Adelaide tool provided a useful basis for MDT discussion and management, where cases were referred to the MDT. We recommend further examination of the tool's utility and impact in clinical decision making, and the distribution of dependencies in a rural cohort compared with metropolitan patients. ", doi="10.2196/16408", url="http://cancer.jmir.org/2020/1/e16408/", url="http://www.ncbi.nlm.nih.gov/pubmed/32255433" } @Article{info:doi/10.2196/14401, author="Tran, Xuan Bach and Latkin, A. Carl and Sharafeldin, Noha and Nguyen, Katherina and Vu, Thu Giang and Tam, S. Wilson W. and Cheung, Ngai-Man and Nguyen, Thi Huong Lan and Ho, H. Cyrus S. and Ho, M. Roger C.", title="Characterizing Artificial Intelligence Applications in Cancer Research: A Latent Dirichlet Allocation Analysis", journal="JMIR Med Inform", year="2019", month="Sep", day="15", volume="7", number="4", pages="e14401", keywords="scientometrics", keywords="cancer", keywords="artificial intelligence", keywords="global", keywords="mapping", abstract="Background: Artificial intelligence (AI)--based therapeutics, devices, and systems are vital innovations in cancer control; particularly, they allow for diagnosis, screening, precise estimation of survival, informing therapy selection, and scaling up treatment services in a timely manner. Objective: The aim of this study was to analyze the global trends, patterns, and development of interdisciplinary landscapes in AI and cancer research. Methods: An exploratory factor analysis was conducted to identify research domains emerging from abstract contents. The Jaccard similarity index was utilized to identify the most frequently co-occurring terms. Latent Dirichlet Allocation was used for classifying papers into corresponding topics. Results: From 1991 to 2018, the number of studies examining the application of AI in cancer care has grown to 3555 papers covering therapeutics, capacities, and factors associated with outcomes. Topics with the highest volume of publications include (1) machine learning, (2) comparative effectiveness evaluation of AI-assisted medical therapies, and (3) AI-based prediction. Noticeably, this classification has revealed topics examining the incremental effectiveness of AI applications, the quality of life, and functioning of patients receiving these innovations. The growing research productivity and expansion of multidisciplinary approaches are largely driven by machine learning, artificial neural networks, and AI in various clinical practices. Conclusions: The research landscapes show that the development of AI in cancer care is focused on not only improving prediction in cancer screening and AI-assisted therapeutics but also on improving other corresponding areas such as precision and personalized medicine and patient-reported outcomes. ", doi="10.2196/14401", url="https://medinform.jmir.org/2019/4/e14401", url="http://www.ncbi.nlm.nih.gov/pubmed/31573929" } @Article{info:doi/10.2196/resprot.9296, author="Herz, D. Naomi and Chalkidou, Anastasia and Reid, Fiona and Keevil, F. Stephen and Coleman, Andrew and Craythorne, Emma and Patalay, Rakesh", title="Evaluating the Diagnostic Accuracy of Reflectance Confocal Microscopy to Diagnose Skin Cancer: Protocol for a Prospective, Multicenter Study", journal="JMIR Res Protoc", year="2018", month="Aug", day="09", volume="7", number="8", pages="e170", keywords="melanoma", keywords="lentigo maligna", keywords="biopsy", keywords="dermoscopy", keywords="reflectance confocal microscopy", abstract="Background: In the United Kingdom, 350,000 patients per year are referred to hospital clinics with suspicious moles, and approximately half undergo a biopsy to identify the 5\%-10\% who require further treatment. If cancer cannot be ruled out clinically and on the basis of biopsy results, the lesion is surgically removed. One type of precancerous mole, called lentigo maligna, is particularly challenging to delineate and treat. Reflectance confocal microscopy (VivaScope, Caliber Imaging \& Diagnostics) is an imaging technique that can supplement dermoscopy in identifying whether a clinically suspicious mole is malignant and can better assess lentigo maligna margins for excision. It allows clinicians to visualize the skin lesion to a depth of 200 microns with subcellular resolution, described as quasi-histological, and therefore better guide more accurate diagnoses. Objective: The aim of this paper is to describe a prospective, single blinded, multicenter study to examine patients with clinically suspicious moles or lentigo maligna to determine whether confocal microscopy can both reduce the number of unnecessary biopsies of moles and more accurately guide the surgical excision margins of lentigo maligna. Methods: This study will prospectively recruit adults into the following two cohorts: diagnostic accuracy and margin delineation. The diagnostic accuracy cohort will assess people with clinically suspicious lesions suspected of being diagnosed with melanoma and having an equivocal finding on dermoscopy or persistent clinical suspicion despite normal dermoscopy. Diagnostic accuracy will include the sensitivity and specificity of VivaScope in comparison with the histological diagnosis as the gold standard for patients. The margin delineation cohort will assess the ability of VivaScope to accurately delineate the margins of lentigo maligna compared with that of dermoscopy alone using margins taken during Mohs micrographic surgery as the gold standard. The primary study outcomes will be the diagnostic accuracy of VivaScope for the first cohort of patients and margin agreement between VivaScope and the final pathology report for the second cohort of patients. Results: Funding for this proposed research is being secured. Conclusions: The outcomes of the proposed study will indicate how many biopsies of nonmelanoma lesions, which are potentially unnecessary, could be prevented. This would reduce patient anxiety and cost to the National Health Service (NHS) in the United Kingdom. Improved margin delineation of lentigo maligna could also improve the surgical clearance rates and decrease overall cost. The results would demonstrate whether the adoption of VivaScope would potentially benefit patients and the NHS. Registered Report Identifier: RR1-10.2196/9296 ", doi="10.2196/resprot.9296", url="http://www.researchprotocols.org/2018/8/e170/", url="http://www.ncbi.nlm.nih.gov/pubmed/30093369" } @Article{info:doi/10.2196/medinform.9171, author="Zarinabad, Niloufar and Meeus, M. Emma and Manias, Karen and Foster, Katharine and Peet, Andrew", title="Automated Modular Magnetic Resonance Imaging Clinical Decision Support System (MIROR): An Application in Pediatric Cancer Diagnosis", journal="JMIR Med Inform", year="2018", month="May", day="02", volume="6", number="2", pages="e30", keywords="clinical decision support", keywords="real-time systems", keywords="magnetic resonance imaging", abstract="Background: Advances in magnetic resonance imaging and the introduction of clinical decision support systems has underlined the need for an analysis tool to extract and analyze relevant information from magnetic resonance imaging data to aid decision making, prevent errors, and enhance health care. Objective: The aim of this study was to design and develop a modular medical image region of interest analysis tool and repository (MIROR) for automatic processing, classification, evaluation, and representation of advanced magnetic resonance imaging data. Methods: The clinical decision support system was developed and evaluated for diffusion-weighted imaging of body tumors in children (cohort of 48 children, with 37 malignant and 11 benign tumors). Mevislab software and Python have been used for the development of MIROR. Regions of interests were drawn around benign and malignant body tumors on different diffusion parametric maps, and extracted information was used to discriminate the malignant tumors from benign tumors. Results: Using MIROR, the various histogram parameters derived for each tumor case when compared with the information in the repository provided additional information for tumor characterization and facilitated the discrimination between benign and malignant tumors. Clinical decision support system cross-validation showed high sensitivity and specificity in discriminating between these tumor groups using histogram parameters. Conclusions: MIROR, as a diagnostic tool and repository, allowed the interpretation and analysis of magnetic resonance imaging images to be more accessible and comprehensive for clinicians. It aims to increase clinicians' skillset by introducing newer techniques and up-to-date findings to their repertoire and make information from previous cases available to aid decision making. The modular-based format of the tool allows integration of analyses that are not readily available clinically and streamlines the future developments. ", doi="10.2196/medinform.9171", url="http://medinform.jmir.org/2018/2/e30/", url="http://www.ncbi.nlm.nih.gov/pubmed/29720361" } @Article{info:doi/10.2196/medinform.8662, author="Zheng, Shuai and Jabbour, K. Salma and O'Reilly, E. Shannon and Lu, J. James and Dong, Lihua and Ding, Lijuan and Xiao, Ying and Yue, Ning and Wang, Fusheng and Zou, Wei", title="Automated Information Extraction on Treatment and Prognosis for Non--Small Cell Lung Cancer Radiotherapy Patients: Clinical Study", journal="JMIR Med Inform", year="2018", month="Feb", day="01", volume="6", number="1", pages="e8", keywords="information extraction", keywords="oncology", keywords="chemoradiation treatment", keywords="prognosis", keywords="non--small cell lung", keywords="information storage and retrieval", keywords="natural language processing", abstract="Background: In outcome studies of oncology patients undergoing radiation, researchers extract valuable information from medical records generated before, during, and after radiotherapy visits, such as survival data, toxicities, and complications. Clinical studies rely heavily on these data to correlate the treatment regimen with the prognosis to develop evidence-based radiation therapy paradigms. These data are available mainly in forms of narrative texts or table formats with heterogeneous vocabularies. Manual extraction of the related information from these data can be time consuming and labor intensive, which is not ideal for large studies. Objective: The objective of this study was to adapt the interactive information extraction platform Information and Data Extraction using Adaptive Learning (IDEAL-X) to extract treatment and prognosis data for patients with locally advanced or inoperable non--small cell lung cancer (NSCLC). Methods: We transformed patient treatment and prognosis documents into normalized structured forms using the IDEAL-X system for easy data navigation. The adaptive learning and user-customized controlled toxicity vocabularies were applied to extract categorized treatment and prognosis data, so as to generate structured output. Results: In total, we extracted data from 261 treatment and prognosis documents relating to 50 patients, with overall precision and recall more than 93\% and 83\%, respectively. For toxicity information extractions, which are important to study patient posttreatment side effects and quality of life, the precision and recall achieved 95.7\% and 94.5\% respectively. Conclusions: The IDEAL-X system is capable of extracting study data regarding NSCLC chemoradiation patients with significant accuracy and effectiveness, and therefore can be used in large-scale radiotherapy clinical data studies. ", doi="10.2196/medinform.8662", url="http://medinform.jmir.org/2018/1/e8/", url="http://www.ncbi.nlm.nih.gov/pubmed/29391345" } @Article{info:doi/10.2196/resprot.5804, author="Catany Ritter, Anna and Egger, Sabrina Annarita and Machacek, Jennifer and Aspalter, Rosa", title="Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival: Protocol of an Online Pilot Cohort Study", journal="JMIR Res Protoc", year="2016", month="Jul", day="29", volume="5", number="3", pages="e157", keywords="cancer", keywords="neoplasms", keywords="diet", keywords="vegans", keywords="vegetarians", keywords="omnivore", keywords="remission", keywords="disease outcome", abstract="Background: Current evidence suggests that the incidence of cancer is low in vegan populations, and experimental studies have revealed a significant role of dietary proteins in cancer development and progression. However, little data currently exists regarding the effect of a plant-based diet on the progression of diagnosed cancer. Objective: The main objective of this study is to determine if a reduction or total elimination of animal protein from the diet can positively influence the outcome of an existing cancer and, in addition to standard oncological therapies, increase remission rates. Methods: The primary aim of this online study is to test the effect on remission rates in cancer patients (primary outcome) with distinct self-selected dietary patterns (omnivore, lacto-ovo-vegetarian, vegan), and allow for an estimation of the effect size. Secondary outcomes are tumor behavior, relapse-free interval, therapies, therapy tolerability and side-effects, comorbidities, medication, quality of life, acceptance, and feasibility of the selected diet. Safety concerns exist for vegan diets (especially in cancer patients) and the study will carefully monitor for deterioration of health, tumor progression, or malnutrition. Furthermore, the study will evaluate the online portal as a study platform (technical and safety aspects, and sequence of displayed questionnaires) as well as the validity of self-reported and online-generated data. Results: The study was performed between April, 2015 and June, 2016, and a preliminary evaluation of safety aspects was undertaken after June, 2016. Primary and secondary outcomes will be evaluated when the final patients complete the study in December, 2016. Conclusions: This study will reveal information about the effects of dietary patterns on cancer disease and progression. The methodology of the study addresses several aspects and limitations of nutrition studies in cancer patients, such as precision of nutrition data, acceptance criteria, online methodology, and safety aspects. ClinicalTrial: Clinicaltrials.gov NCT02437474; https://clinicaltrials.gov/ct2/show/NCT02437474 (Archived by WebCite at http://www.webcitation.org/6jL7UUCVq) ", doi="10.2196/resprot.5804", url="http://www.researchprotocols.org/2016/3/e157/", url="http://www.ncbi.nlm.nih.gov/pubmed/27473726" } @Article{info:doi/10.2196/resprot.5757, author="Peppelman, Malou and Nguyen, P. Kim and Alkemade, A.C Hans and Maessen-Visch, Birgitte and Hendriks, C.M Jan and van Erp, E.J Piet and Adang, M.M Eddy and Gerritsen, P. Marie-Jeanne", title="Diagnosis of Basal Cell Carcinoma by Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial", journal="JMIR Res Protoc", year="2016", month="Jun", day="30", volume="5", number="2", pages="e114", keywords="basal cell carcinoma", keywords="reflectance confocal microscopy", keywords="diagnosis", keywords="cost effectiveness", abstract="Background: Skin cancer, including basal cell carcinoma (BCC), has become a major health care problem. The limitations of a punch biopsy (at present the gold standard) as diagnostic method together with the increasing incidence of skin cancer point out the need for more accurate, cost-effective, and patient friendly diagnostic tools. In vivo reflectance confocal microscopy (RCM) is a noninvasive imaging technique that has great potential for skin cancer diagnosis. Objective: To investigate whether in vivo RCM can correctly identify the subtype of BCC and to determine the cost-effectiveness of RCM compared with punch biopsy (usual care). Study design: Randomized controlled multicenter trial. Methods: On the basis of 80\% power and an alpha of 0.05, 329 patients with lesions clinically suspicious for BCC will be included in this study. Patients will be randomized for RCM or for a punch biopsy (usual care). When a BCC is diagnosed, surgical excision will follow and a follow-up visit will be planned 3 months later. Several questionnaires will be filled in (EQ-5D, EQ-5D VAS, iMTA PCQ, and TSQM-9). We will perform statistical analysis, cost-effectiveness, and patient outcome analysis after data collection. Results: This research started in January 2016 and is ethically approved. We expect to finish this study at the end of 2018. Conclusions: In this study, we will investigate whether RCM is at least as good in identifying BCC subtypes as conventional pathological investigation of skin biopsies. Anticipating that RCM is found to be a cost-effective alternative, it saves on direct medical consumption like labor of the pathologist and other medical personnel as well as materials related to treatment failure with at least equal effectiveness. Trial Registration: Clinicaltrials.gov NCT02623101; https://clinicaltrials.gov/ct2/show/NCT02623101 (Archived by WebCite at http://www.webcitation.org/6id54WQa2) ", doi="10.2196/resprot.5757", url="http://www.researchprotocols.org/2016/2/e114/", url="http://www.ncbi.nlm.nih.gov/pubmed/27363577" } @Article{info:doi/10.2196/resprot.4303, author="Kadouch, J. Daniel and Wolkerstorfer, Albert and Elshot, Yannick and Zupan-Kajcovski, Biljana and Crijns, B. Marianne and Starink, V. Markus and Bekkenk, W. Marcel and van der Wal, C. Allard and Spuls, I. Phyllis and de Rie, A. Menno", title="Treatment of Basal Cell Carcinoma Using a One-Stop-Shop With Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial", journal="JMIR Res Protoc", year="2015", month="Sep", day="10", volume="4", number="3", pages="e109", keywords="carcinoma, basal cell", keywords="microscopy, confocal", keywords="diagnostic services", keywords="sensitivity and specificity", keywords="surgical procedures, operative", abstract="Background: Basal cell carcinoma (BCC) is the most common cancer diagnosed in white populations worldwide. The rising incidence of BCC is becoming a major worldwide public health problem. Therefore, there is a need for more efficient management. Objective: The aim of this research is to assess the efficacy and safety of a one-stop-shop (OSS) concept, using real-time in vivo reflectance confocal microscopy (RCM) (Vivascope 1500; Lucid Technologies, Henrietta, NY, USA) as a diagnostic tool, prior to surgical management of new primary BCCs. Methods: This is a prospective non-inferiority multi-center RCT designed to compare the ``OSS concept using RCM'' to current standards of care in diagnosing and treating clinically suspected BCC. Patients ? 18 years attending our outpatient clinic at the Department of Dermatology, Academic Medical Center, University of Amsterdam, and the Department of Dermatology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (Amsterdam, The Netherlands) with a clinically suspected new primary BCC lesion will be considered for enrollment using predefined inclusion and exclusion criteria, and will be randomly allocated to the experimental or control group. The main outcome parameter is the assessment of incomplete surgical excision margins on the final pathology report of confirmed BCC lesions (either by punch biopsy or RCM imaging). Other outcome measures include diagnostic accuracy (sensitivity and specificity) of RCM for diagnosing BCC and dividing between subtypes, and throughput time. Patient satisfaction data will be collected postoperatively after 3 months during routine follow-up. Results: This research is investigator-initiated and received ethics approval. Patient recruitment started in February 2015, and we expect all study-related activities to be completed by fall 2015. Conclusions: This RCT is the first to examine an OSS concept using RCM for diagnosing and treating clinically suspected BCC lesions. Results of this research are expected to have applications in evidence-based practice for the increasing number of patients suffering from BCC and possibly lead to a more efficient disease management strategy. Trial Registration: ClinicalTrials.gov: NCT02285790; https://clinicaltrial.gov/ct2/show/NCT02285790 (Archived by WebCite at http://www.webcitation.org/6b2LfDKWu). ", doi="10.2196/resprot.4303", url="http://www.researchprotocols.org/2015/3/e109/", url="http://www.ncbi.nlm.nih.gov/pubmed/26362616" } @Article{info:doi/10.2196/resprot.4320, author="Noordman, Jan Bo and Shapiro, Joel and Spaander, CW Manon and Krishnadath, K. Kausilia and van Laarhoven, WM Hanneke and van Berge Henegouwen, I. Mark and Nieuwenhuijzen, AP Grard and van Hillegersberg, Richard and Sosef, N. Meindert and Steyerberg, W. Ewout and Wijnhoven, PL Bas and van Lanschot, B. J. Jan", title="Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol", journal="JMIR Res Protoc", year="2015", month="Jun", day="29", volume="4", number="2", pages="e79", keywords="esophageal cancer", keywords="neoadjuvant chemoradiotherapy", keywords="esophagectomy", keywords="surgery as needed", keywords="active surveillance policy", abstract="Background: Results from the recent CROSS trial showed that neoadjuvant chemoradiotherapy (nCRT) significantly increased survival as compared to surgery alone in patients with potentially curable esophageal cancer. Furthermore, in the nCRT arm 49\% of patients with a squamous cell carcinoma (SCC) and 23\% of patients with an adenocarcinoma (AC) had a pathologically complete response in the resection specimen. These results provide a rationale to reconsider and study the timing and necessity of esophagectomy in (all) patients after application of the CROSS regimen. Objective: We propose a ``surgery as needed'' approach after completion of nCRT. In this approach, patients will undergo active surveillance after completion of nCRT. Surgical resection would be offered only to those patients in whom residual disease or a locoregional recurrence is highly suspected or proven. However, before a surgery as needed approach in oesophageal cancer patients (SANO) can be tested in a randomized controlled trial, we aim to determine the accuracy of detecting the presence or absence of residual disease after nCRT (preSANO trial). Methods: This study is set up as a prospective, single arm, multicenter, diagnostic trial. Operable patients with potentially curable SCC or AC of the esophagus or esophagogastric junction will be included. Approximately 4-6 weeks after completion of nCRT all included patients will undergo a first clinical response evaluation (CRE-I) including endoscopy with (random) conventional mucosal biopsies of the primary tumor site and of any other suspected lesions in the esophagus and radial endo-ultrasonography (EUS) for measurement of tumor thickness and area. Patients in whom no locoregional or disseminated disease can be proven by cytohistology will be offered a postponed surgical resection 6-8 weeks after CRE-I (ie, approximately 12-14 weeks after completion of nCRT). In the week preceding the postponed surgical resection, a second clinical response evaluation (CRE-II) will be planned that will include a whole body PET-CT, followed again by endoscopy with (random) conventional mucosal biopsies of the primary tumor site and any other suspected lesions in the esophagus, radial EUS for measurement of tumor thickness and area, and linear EUS plus fine needle aspiration of PET-positive lesions and/or suspected lymph nodes. The main study parameter is the correlation between the clinical response assessment during CRE-I and CRE-II and the final pathological response in the resection specimen. Results: The first patient was enrolled on July 23, 2013, and results are expected in January 2016. Conclusions: If this preSANO trial shows that the presence or absence of residual tumor can be predicted reliably 6 or 12 weeks after completion of nCRT, a randomized trial comparing nCRT plus standard surgery versus chemoradiotherapy plus ``surgery as needed'' will be conducted (SANO trial). Trial Registration: Netherlands Trial Register: NTR4834; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4834 (archived by Webcite at http://www.webcitation.org/6Ze7mn67B). ", doi="10.2196/resprot.4320", url="http://www.researchprotocols.org/2015/2/e79/", url="http://www.ncbi.nlm.nih.gov/pubmed/26121676" }