@Article{info:doi/10.2196/71612,
author="Huis in 't Veld, A. Evangeline
and Kruse, M. Anouk
and Verwaaijen, J. Emma
and Huizer, C. Sterre
and van Dijk-Lokkart, M. Elisabeth
and Lok, Christianne
and Kuethe, Maaike
and Amant, Frederic
and van Gerwen, A. Mathilde M.
and van Grotel, Martine
and van den Heuvel-Eibrink, M. Marry",
title="The First 6 Years' Experiences of a National Centralized Offspring Surveillance Setting for Dutch Children Prenatally Exposed to Maternal Cancer to Inform Future International Practice: Protocol for a Demographic Review of Referred Families and Key Lessons Learned",
journal="JMIR Res Protoc",
year="2025",
month="Jun",
day="24",
volume="14",
pages="e71612",
keywords="surveillance",
keywords="offspring",
keywords="outpatient clinic",
keywords="cancer",
keywords="treatment",
keywords="exposure in utero, toxic effects",
abstract="Background: Cancer during pregnancy is a rare and significant life-changing event affecting approximately 1 in 1000-2000 pregnancies. With increasing maternal age and broader application of prenatal screening programs such as the Dutch Non-Invasive Prenatal Testing, incidental detection of maternal cancer is becoming more frequent. Advancements in safe treatment options during pregnancy, supported by the International Network on Cancer Infertility and Pregnancy (INCIP), have led to fewer pregnancy terminations. Consequently, more children are exposed to chemotherapy and other cancer treatments in utero. While short-term safety has been demonstrated for many oncological agents, long-term side effects including physical, neuromotor, neurocognitive, and psychosocial impacts on offspring and their families after delivery are still being assessed. Standard settings for surveillance and care of offspring and their families have, however, never been described. Objective: Given the importance of expertise in assessing the long-term outcomes of children, the Netherlands established the national centralized Cancer in Pregnancy (CIP) offspring outpatient clinic in 2018, which functions as a standard-of-care surveillance clinic and contributes data to the INCIP registry. Here we provide a demographic overview of referred families and to share (logistic) experiences with the national, centralized, multidisciplinary, and standardized long-term surveillance program for all Dutch children with in utero exposure to maternal cancer and its treatment. Methods: The CIP offspring outpatient clinic is located at the Princess M{\'a}xima Center for Pediatric Oncology and provides surveillance from infancy until 18 years of age. The, relatively small dedicated team, comprising pediatric oncologists, physiotherapists, and a psychological expert, offers a 1-day, multidisciplinary assessment, including physical examinations, neuromotor tests, cardiac monitoring (for anthracycline exposure), renal and auditory screening (for platinum agents), neurocognitive testing, and psychosocial evaluation. Surveillance is aligned with international INCIP guidelines. Results: From May 2018 to 2024, a total of 226 children (from 221 mothers) have been referred to the CIP offspring outpatient clinic, with 465 follow-up visits completed. The most common maternal cancer types were breast, gynecological, and hematological malignancies. Most women (58\%) received chemotherapy during pregnancy; 11\% of them had surgery only, 3\% underwent radiotherapy, 3\% underwent immunotherapy, 16\% received a combination of treatment modalities, and 8\% did not undergo treatment during pregnancy. Anthracyclines were the most commonly used agents. Median gestational age at delivery was 37.3 weeks. Fourteen percent of the mothers died shortly after delivery, underscoring the emotional and logistical challenges for families. Conclusions: The CIP offspring outpatient clinic provides a unique, structured approach to long-term surveillance for in utero--exposed children, which enables early detection of potential late effects and provides comprehensive family support. By sharing knowledge and experiences from the unique setting of this national centralized CIP offspring outpatient clinic, this initiative may inspire other countries in developing similar translational facilities to support affected families and improve care worldwide. International Registered Report Identifier (IRRID): DERR1-10.2196/71612 ",
doi="10.2196/71612",
url="https://www.researchprotocols.org/2025/1/e71612",
url="http://www.ncbi.nlm.nih.gov/pubmed/40554782"
}


@Article{info:doi/10.2196/56825,
author="Sajjanar, Anita
and Vagha, Sunita",
title="Assessing the Efficacy of Current Histopathological Tumor Reporting Systems for Evaluating the Response to Neoadjuvant Chemotherapy for Breast Carcinoma: Protocol for an Observational Study",
journal="JMIR Res Protoc",
year="2025",
month="Jun",
day="16",
volume="14",
pages="e56825",
keywords="evaluation",
keywords="comparison",
keywords="histopathological assessment systems",
keywords="breast carcinoma",
keywords="neoadjuvant chemotherapy",
keywords="prognosis",
keywords="hormone receptor status",
keywords="lymphnode status",
keywords="residual cancer burden",
keywords="Miller-Payne system",
keywords="Chevallier classification",
keywords="Sataloff classification",
keywords="AJCC residual tumor size (R)",
keywords="clinical decision making",
keywords="treatment outcome",
abstract="Background: With a predicted 2 million new cases identified globally in 2018, breast carcinomas are the most common cancer in women and the primary cause of cancer-associated mortality. In the management of breast cancer, neoadjuvant chemotherapy treatment (NACT) has become a mainstay, particularly for patients with inflammatory and locally advanced breast cancer. It increases the possibility of breast-conserving surgery, facilitates tumor downstaging, and gives early indications of the effectiveness of treatment. Evaluating the histopathological response after NACT is crucial for prognosis and guiding subsequent treatment decisions. This study explores the various histopathological assessment systems used in breast carcinoma patients after NACT, focusing on the residual cancer burden (RCB) score, Miller-Payne system, Chevallier classification, Sataloff classification, National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-18 system, and the American Joint Committee on Cancer residual tumor size (R) categories. We compare their methodologies, strengths, limitations, and clinical significance, providing a detailed analysis of their roles in improving patient outcomes. Objective: The aim of this study is to confirm the diagnosis of breast carcinoma based on histopathology, to evaluate various scoring systems through assessments of histomorphological features affecting post-NACT patients with breast carcinoma, to compare the various systems regarding the response to therapy and forming prognoses, and to develop an ideal histomorphological assessment system for breast carcinoma in post-NACT patients. The study also focused on how breast tumors respond to NACT and how this response can guide treatment decisions and improve the formulation of prognoses. Methods: This observational study will be retrospective and prospective; it will include 128 patients diagnosed with breast carcinomas who have undergone NACT and were referred to a tertiary care hospital between January 2019 and December 2024. Following chemotherapy, a thorough examination of the histopathological specimens will be conducted to assess any changes in histomorphology. Results: Data collection started in September 2021 and will be completed by December 2025. Data analysis began in January 2025, and the results are expected to be published in December 2025. Institutional ethics committee clearance was obtained prior to commencement of the study. This is a nonfunded academic study. Conclusions: This project aims to evaluate and compare histopathological assessment systems in patients with breast carcinoma after NACT. Various histopathological systems, such as the RCB score, the Miller-Payne grading system, and other systems, each provide valuable insights into how well tumors respond to chemotherapy. The aim is to reveal essential histopathological parameters, leading to the refinement and potential modification of grading systems to improve clinical decision-making, treatment outcomes, and personalized care; however, challenges persist in standardization and consensus. International Registered Report Identifier (IRRID): DERR1-10.2196/56825 ",
doi="10.2196/56825",
url="https://www.researchprotocols.org/2025/1/e56825"
}


@Article{info:doi/10.2196/67875,
author="Saint-Lary, Laura
and Pinel, Baptiste
and Panh, Loic
and Jimenez, Gaelle
and Geffrelot, Julien
and Kirova, Youlia
and Camilleri, Jeremy
and Broggio, David
and Bernier, Marie-Odile
and Mandin, Corinne
and Levy, Christelle
and Boveda, Serge
and Thariat, Juliette
and Jacob, Sophie",
title="Screening and Risk Analysis of Atrial Fibrillation After Radiotherapy for Breast Cancer: Protocol for the Cross-Sectional Cohort Study ``Watch Your Heart (WATCH)''",
journal="JMIR Res Protoc",
year="2025",
month="Jun",
day="4",
volume="14",
pages="e67875",
keywords="breast cancer",
keywords="radiotherapy",
keywords="atrial fibrillation",
keywords="smartwatch",
keywords="arrhythmia",
keywords="cardiac dosimetry",
abstract="Background: Atrial fibrillation (AF) after radiotherapy (RT) in patients with breast cancer (BC) is a relatively new and understudied topic. AF can increase the risk of stroke and other serious cardiovascular complications, compromising patients' quality of life and survival. Screening of AF, both asymptomatic and symptomatic forms, is therefore essential for optimal management. Objective: The aim of the Watch Your Heart After Radiotherapy for Breast Cancer (WATCH) study is to assess the incidence of AF (symptomatic or asymptomatic) occurring throughout a 5-year follow-up after RT and to investigate whether cardiac radiation exposure is associated with the occurrence of such events. Methods: WATCH is a cohort study that will include 200 patients over 65 years old, treated with RT for BC 5 years before inclusion and without a history of AF. Cross-sectional screening for AF at the time of the scheduled 5-year post-RT visit will be conducted by recording data from a Withings ScanWatch smartwatch for 1 month, confirmed by an electrocardiogram (ECG), and validated by a physician. In addition, a transthoracic echocardiography (TTE) will be performed, providing a comprehensive assessment of cardiac structures, and allowing us to investigate the underlying etiology and assess the risk of complications. Patients' medical records will provide retrospective information about the timing and risk factors for the occurrence of AF and other arrhythmias and cardiac diseases during the 5 years following RT. The development of deep learning algorithms for autosegmentation analysis of potentially critical substructures for the occurrence of AF, including cardiac chambers, the sinoatrial node, the atrioventricular node, coronary arteries, and pulmonary veins (PVs), will produce dosimetry linked to previous RT treatment for all contoured structures. Results: Enrollment started in October 2023 and will continue until mid-2026 to include 200 patients, which will ensure an 80\% statistical power to detect a significant difference in AF incidence around 15\% for the group of patients moderately exposed (<75th percentile of the mean heart radiation dose) and 25\% for the group of patients highly exposed (>75th percentile of the mean heart radiation dose). The results are expected by the end of 2026. Conclusions: This study will contribute to generating new knowledge on AF after RT for BC and help considering the inclusion of AF screening into routine clinical practice for these patients. Identifying the dose-risk associations would improve RT delivery protocols to limit the occurrence of different forms of AF and, if necessary, initiate appropriate treatment. Trial Registration: ClinicalTrials.gov NCT06073509; clinicaltrials.gov/study/NCT06073509?id=NCT06073509\&rank=1. International Registered Report Identifier (IRRID): DERR1-10.2196/67875 ",
doi="10.2196/67875",
url="https://www.researchprotocols.org/2025/1/e67875"
}


@Article{info:doi/10.2196/69855,
author="Deutsch, M. Thomas
and Volmer, L. L{\'e}a
and Feisst, Manuel
and Bodenbeck, Laura
and Hassdenteufel, Kathrin
and Tretschock, Lara
and Breit, Christiane
and Stefanovic, Stefan
and Bauer, Armin
and Anders, Carolin
and Weinert, Lina
and Engler, Tobias
and Hartkopf, D. Andreas
and Pfeifer, Nico
and Escher, Pascal
and Mausch, Marc
and Heinze, Oliver
and Suetterlin, Marc
and Brucker, Y. Sara
and Schneeweiss, Andreas
and Wallwiener, Markus",
title="ENABLE---App-Based Digital Capture and Intervention of Patient-Reported Quality of Life, Adverse Events, and Treatment Satisfaction in Breast Cancer: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="May",
day="26",
volume="14",
pages="e69855",
keywords="breast cancer",
keywords="electronic patient-reported outcomes",
keywords="ePRO",
keywords="health-related quality of life",
keywords="HRQoL",
keywords="eHealth apps",
abstract="Background: In recent years, breast cancer treatment has taken the path toward personalized medicine. Based on individual tumor biology, therapy tailored to the particular subtype of cancer is increasingly being used. The aim here is to find the most suitable therapy for the disease. However, the success of therapy depends to a large extent on the patient's adherence to treatment. This, in turn, depends on how the therapy is tolerated and how the treatment team cares for the patient. Patient-centered care seeks to identify and address the individual needs of each patient and to find the best form of care for that person. Objective: In order to improve comprehensive oncological care of patients with breast cancer, the ENABLE trial digitally recorded the health-related quality of life (HRQoL), adverse events (AEs), and patient satisfaction using a mobile smartphone app. The trial provided individualized responses to reported AEs and offered assistance. Additionally, it assessed the impact of a patient-reported outcome--based intervention across various therapy settings. Methods: Patients with breast cancer were eligible to participate in the study before neoadjuvant, adjuvant, postneoadjuvant, or palliative systemic therapy against breast cancer was initiated at the Heidelberg, Mannheim, and Tuebingen, Germany, university hospitals. After 1:1 randomization into an intervention and a control group, HRQoL assessments were performed at six fixed time points during the therapy using validated questionnaires. In the intervention group, HRQoL was also assessed briefly every week using a visual analog scale (EQ-VAS). In cases of significant deterioration, therapy-associated side effects were assessed in a graduated manner, recommendations were sent to the patient, and the treatment team was informed. Additionally, the app served as an ``eHealth companion'' for education, training, and organizational support during therapy. Results: Recruitment started in March 2021; follow-up was completed in February 2024. In total, 606 patients were enrolled, and 592 patients participated in the study. Enrollment was completed in September 2023, and the last visit was in February 2024. The first results are expected to be published in Q2 2025. Conclusions: Participation in the intervention group is expected to improve treatment satisfaction, adherence, detection, and timely treatment of critical AEs. The close-meshed, weekly, brief HRQoL assessment will also be tested as a screening tool to detect relevant side effects during therapy. The study offers a more objective HRQoL assessment across treatment strategies. Trial Registration: Deutsches Register Klinischer Studien DRKS00025611; https://drks.de/search/en/trial/DRKS00025611 International Registered Report Identifier (IRRID): DERR1-10.2196/69855 ",
doi="10.2196/69855",
url="https://www.researchprotocols.org/2025/1/e69855"
}


@Article{info:doi/10.2196/63627,
author="J{\"o}rger, Philippa
and Nigg, Carina
and Mader, Luzius
and Strebel, Sven
and Kompis, Martin
and Tom{\'a}{\vs}ikov{\'a}, Zuzana
and Schindera, Christina
and Michel, Gisela
and von der Weid, Xavier Nicolas
and Ansari, Marc
and Waespe, Nicolas
and Kuehni, Elisabeth Claudia",
title="A Health Service Research Study on a Low-Threshold Hearing Screening Program for Childhood Cancer Survivors in Switzerland: Protocol for the HEAR Study",
journal="JMIR Res Protoc",
year="2025",
month="May",
day="21",
volume="14",
pages="e63627",
keywords="hearing screening",
keywords="hearing problems",
keywords="ototoxicity",
keywords="platinum compounds",
keywords="cranial radiotherapy",
keywords="low-threshold screening",
keywords="aftercare",
keywords="childhood cancer survivors",
keywords="participatory research",
keywords="long-term follow-up",
keywords="implementation science",
abstract="Background: Hearing loss is a common late effect in childhood cancer survivors, caused by ototoxic cancer treatments, such as platinum chemotherapy, cranial radiation with doses of ?30 Gray, and surgery involving the auditory system. Early recognition of hearing loss as part of follow-up care allows for therapeutic support to mitigate consequences. However, hearing tests are usually only repeated in childhood cancer survivors with abnormal hearing during or right after treatment ends, leaving hearing loss undetected in childhood cancer survivors with late onset or when missed during cancer treatment. Further, general follow-up care attendance may be low after childhood cancer survivors transition to adult care, contributing to missing hearing screening posttherapy. Low attendance may be attributed to childhood cancer survivors finding follow-up care burdensome and time-consuming, lacking awareness of their risk for certain late effects, or the absence of suitable interdisciplinary follow-up clinics. A low-threshold, easily accessible screening program requiring minimal participant effort may address these barriers and improve access to hearing loss screening for childhood cancer survivors. Objective: The HEAR study aims to develop, conduct, and evaluate the feasibility of a low-threshold, community-based screening program for hearing loss in childhood cancer survivors, using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, a tool to plan and evaluate health interventions. Within the screening program, participating childhood cancer survivors completed a standardized hearing assessment at a local Swiss hearing aid provider's shop. This approach provides low-threshold access to detect hearing loss as it is easily and conveniently accessible for everyone. Methods: Eligible childhood cancer survivors were identified through the Childhood Cancer Registry Switzerland and included those diagnosed with cancer between 1976 and 2019 before 21 years and who were ?2 years post diagnosis. We invited eligible childhood cancer survivors by post. Participants scheduled a hearing test appointment at a hearing aid shop. They completed a baseline questionnaire before the hearing test, and 2 follow-up questionnaires afterward to assess program feasibility and participant experiences. Semistructured interviews with participants, hearing aid shop staff, and group discussions with health care professionals will provide qualitative insights. The RE-AIM framework will guide the program evaluation using the quantitative and qualitative data collected. Results: As of February 2025, all participants have been recruited, and all steps of the study up to the group discussions and the RE-AIM evaluation have been completed. Conclusions: The HEAR study introduces a novel, simple, and low-threshold approach to screening for hearing loss after cancer treatment through hearing aid shops located in the community and close to participants' homes. This approach has the potential to supplement existing follow-up care programs by reducing the burden of hearing screening for adult childhood cancer survivors and reaching those who might otherwise be lost to follow-up. Trial Registration: ClinicalTrials.gov NCT06036407; https://clinicaltrials.gov/study/NCT06036407 International Registered Report Identifier (IRRID): DERR1-10.2196/63627 ",
doi="10.2196/63627",
url="https://www.researchprotocols.org/2025/1/e63627"
}


@Article{info:doi/10.2196/66161,
author="Li, Yilan
and Gu, Tianshu
and Yang, Chengyuan
and Li, Minghui
and Wang, Congyi
and Yao, Lan
and Gu, Weikuan
and Sun, DianJun",
title="AI-Assisted Hypothesis Generation to Address Challenges in Cardiotoxicity Research: Simulation Study Using ChatGPT With GPT-4o",
journal="J Med Internet Res",
year="2025",
month="May",
day="15",
volume="27",
pages="e66161",
keywords="cardiotoxicity",
keywords="ChatGPT with GPT-4o",
keywords="artificial intelligence",
keywords="AI",
keywords="heart",
keywords="hypothesis generation",
abstract="Background: Cardiotoxicity is a major concern in heart disease research because it can lead to severe cardiac damage, including heart failure and arrhythmias. Objective: This study aimed to explore the ability of ChatGPT with GPT-4o to generate innovative research hypotheses to address 5 major challenges in cardiotoxicity research: the complexity of mechanisms, variability among patients, the lack of detection sensitivity, the lack of reliable biomarkers, and the limitations of animal models. Methods: ChatGPT with GPT-4o was used to generate multiple hypotheses for each of the 5 challenges. These hypotheses were then independently evaluated by 3 experts for novelty and feasibility. ChatGPT with GPT-4o subsequently selected the most promising hypothesis from each category and provided detailed experimental plans, including background, rationale, experimental design, expected outcomes, potential pitfalls, and alternative approaches. Results: ChatGPT with GPT-4o generated 96 hypotheses, of which 13 (14\%) were rated as highly novel and 62 (65\%) as moderately novel. The average group score of 3.85 indicated a strong level of innovation in these hypotheses. Literature searching identified at least 1 relevant publication for 28 (29\%) of the 96 hypotheses. The selected hypotheses included using single-cell RNA sequencing to understand cellular heterogeneity, integrating artificial intelligence with genetic profiles for personalized cardiotoxicity risk prediction, applying machine learning to electrocardiogram data for enhanced detection sensitivity, using multi-omics approaches for biomarker discovery, and developing 3D bioprinted heart tissues to overcome the limitations of animal models. Our group's evaluation of the 30 dimensions of the experimental plans for the 5 hypotheses selected by ChatGPT with GPT-4o revealed consistent strengths in the background, rationale, and alternative approaches, with most of the hypotheses (20/30, 67\%) receiving scores of ?4 in these areas. While the hypotheses were generally well received, the experimental designs were often deemed overly ambitious, highlighting the need for more practical considerations. Conclusions: Our study demonstrates that ChatGPT with GPT-4o can generate innovative and potentially impactful hypotheses for overcoming critical challenges in cardiotoxicity research. These findings suggest that artificial intelligence--assisted hypothesis generation could play a crucial role in advancing the field of cardiotoxicity, leading to more accurate predictions, earlier detection, and better patient outcomes. ",
doi="10.2196/66161",
url="https://www.jmir.org/2025/1/e66161"
}


@Article{info:doi/10.2196/64697,
author="Varma, Gowtham
and Yenukoti, Kumar Rohit
and Kumar M, Praveen
and Ashrit, Sai Bandlamudi
and Purushotham, K.
and Subash, C.
and Ravi, Kumar Sunil
and Kurien, Verghese
and Aman, Avinash
and Manoharan, Mithun
and Jaiswal, Shashank
and Anand, Akash
and Barve, Rakesh
and Thiagarajan, Viswanathan
and Lenehan, Patrick
and Soefje, A. Scott
and Soundararajan, Venky",
title="A Deep Learning--Enabled Workflow to Estimate Real-World Progression-Free Survival in Patients With Metastatic Breast Cancer: Study Using Deidentified Electronic Health Records",
journal="JMIR Cancer",
year="2025",
month="May",
day="15",
volume="11",
pages="e64697",
keywords="real-world evidence",
keywords="data-driven oncology",
keywords="real-world progression-free survival",
keywords="metastatic breast cancer",
keywords="natural language processing",
keywords="NLP",
keywords="survival",
keywords="cancer",
keywords="oncology",
keywords="breast",
keywords="metastatic",
keywords="deep learning",
keywords="machine learning",
keywords="ML",
keywords="workflow",
keywords="report",
keywords="notes",
keywords="electronic health record",
keywords="EHR",
keywords="documentation",
abstract="Background: Progression-free survival (PFS) is a crucial endpoint in cancer drug research. Clinician-confirmed cancer progression, namely real-world PFS (rwPFS) in unstructured text (ie, clinical notes), serves as a reasonable surrogate for real-world indicators in ascertaining progression endpoints. Response evaluation criteria in solid tumors (RECIST) is traditionally used in clinical trials using serial imaging evaluations but is impractical when working with real-world data. Manual abstraction of clinical progression from unstructured notes remains the gold standard. However, this process is a resource-intensive, time-consuming process. Natural language processing (NLP), a subdomain of machine learning, has shown promise in accelerating the extraction of tumor progression from real-world data in recent years. Objectives: We aim to configure a pretrained, general-purpose health care NLP framework to transform free-text clinical notes and radiology reports into structured progression events for studying rwPFS on metastatic breast cancer (mBC) cohorts. Methods: This study developed and validated a novel semiautomated workflow to estimate rwPFS in patients with mBC using deidentified electronic health record data from the Nference nSights platform. The developed workflow was validated in a cohort of 316 patients with hormone receptor--positive, human epidermal growth factor receptor-2 (HER-2) 2-negative mBC, who were started on palbociclib and letrozole combination therapy between January 2015 and December 2021. Ground-truth datasets were curated to evaluate the workflow's performance at both the sentence and patient levels. NLP-captured progression or a change in therapy line were considered outcome events, while death, loss to follow-up, and end of the study period were considered censoring events for rwPFS computation. Peak reduction and cumulative decline in Patient Health Questionnaire-8 (PHQ-8) scores were analyzed in the progressed and nonprogressed patient subgroups. Results: The configured clinical NLP engine achieved a sentence-level progression capture accuracy of 98.2\%. At the patient level, initial progression was captured within {\textpm}30 days with 88\% accuracy. The median rwPFS for the study cohort (N=316) was 20 (95\% CI 18-25) months. In a validation subset (n=100), rwPFS determined by manual curation was 25 (95\% CI 15-35) months, closely aligning with the computational workflow's 22 (95\% CI 15-35) months. A subanalysis revealed rwPFS estimates of 30 (95\% CI 24-39) months from radiology reports and 23 (95\% CI 19-28) months from clinical notes, highlighting the importance of integrating multiple note sources. External validation also demonstrated high accuracy (92.5\% sentence level; 90.2\% patient level). Sensitivity analysis revealed stable rwPFS estimates across varying levels of missing source data and event definitions. Peak reduction in PHQ-8 scores during the study period highlighted significant associations between patient-reported outcomes and disease progression. Conclusions: This workflow enables rapid and reliable determination of rwPFS in patients with mBC receiving combination therapy. Further validation across more diverse external datasets and other cancer types is needed to ensure broader applicability and generalizability. ",
doi="10.2196/64697",
url="https://cancer.jmir.org/2025/1/e64697"
}


@Article{info:doi/10.2196/63964,
author="Mushcab, Hayat
and Al Ramis, Mohammed
and AlRujaib, Abdulrahman
and Eskandarani, Rawan
and Sunbul, Tamara
and AlOtaibi, Anwar
and Obaidan, Mohammed
and Al Harbi, Reman
and Aljabri, Duaa",
title="Application of Artificial Intelligence in Cardio-Oncology Imaging for Cancer Therapy--Related Cardiovascular Toxicity: Systematic Review",
journal="JMIR Cancer",
year="2025",
month="May",
day="9",
volume="11",
pages="e63964",
keywords="artificial intelligence",
keywords="cardiology",
keywords="oncology",
keywords="cancer therapy--induced",
keywords="cardiotoxicity",
keywords="cardiovascular toxicity",
keywords="machine learning",
keywords="imaging",
keywords="radiology",
abstract="Background: Artificial intelligence (AI) is a revolutionary tool yet to be fully integrated into several health care sectors, including medical imaging. AI can transform how medical imaging is conducted and interpreted, especially in cardio-oncology. Objective: This study aims to systematically review the available literature on the use of AI in cardio-oncology imaging to predict cardiotoxicity and describe the possible improvement of different imaging modalities that can be achieved if AI is successfully deployed to routine practice. Methods: We conducted a database search in PubMed, Ovid MEDLINE, Cochrane Library, CINAHL, and Google Scholar from inception to 2023 using the AI research assistant tool (Elicit) to search for original studies reporting AI outcomes in adult patients diagnosed with any cancer and undergoing cardiotoxicity assessment. Outcomes included incidence of cardiotoxicity, left ventricular ejection fraction, risk factors associated with cardiotoxicity, heart failure, myocardial dysfunction, signs of cancer therapy--related cardiovascular toxicity, echocardiography, and cardiac magnetic resonance imaging. Descriptive information about each study was recorded, including imaging technique, AI model, outcomes, and limitations. Results: The systematic search resulted in 7 studies conducted between 2018 and 2023, which are included in this review. Most of these studies were conducted in the United States (71\%), included patients with breast cancer (86\%), and used magnetic resonance imaging as the imaging modality (57\%). The quality assessment of the studies had an average of 86\% compliance in all of the tool's sections. In conclusion, this systematic review demonstrates the potential of AI to enhance cardio-oncology imaging for predicting cardiotoxicity in patients with cancer. Conclusions: Our findings suggest that AI can enhance the accuracy and efficiency of cardiotoxicity assessments. However, further research through larger, multicenter trials is needed to validate these applications and refine AI technologies for routine use, paving the way for improved patient outcomes in cancer survivors at risk of cardiotoxicity. Trial Registration: PROSPERO CRD42023446135; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023446135 ",
doi="10.2196/63964",
url="https://cancer.jmir.org/2025/1/e63964"
}


@Article{info:doi/10.2196/64083,
author="Huebner, Hanna
and Wurmthaler, A. Lena
and Goossens, Chlo{\"e}
and Ernst, Mathias
and Mocker, Alexander
and Kr{\"u}ckel, Annika
and Kallert, Maximilian
and Geck, J{\"u}rgen
and Limpert, Milena
and Seitz, Katharina
and Ruebner, Matthias
and Kreis, Philipp
and Heindl, Felix
and H{\"o}rner, Manuel
and Volz, Bernhard
and Roth, Eduard
and Hack, C. Carolin
and Beckmann, W. Matthias
and Uhrig, Sabrina
and Fasching, A. Peter",
title="A Digital Home-Based Health Care Center for Remote Monitoring of Side Effects During Breast Cancer Therapy: Prospective, Single-Arm, Monocentric Feasibility Study",
journal="JMIR Cancer",
year="2025",
month="May",
day="2",
volume="11",
pages="e64083",
keywords="breast cancer",
keywords="digital medicine",
keywords="telehealth",
keywords="remote monitoring",
keywords="cyclin-dependent kinase 4/6 inhibitor",
keywords="CDK4/6 inhibitor",
keywords="mobile phone",
abstract="Background: The introduction of oral anticancer therapies has, at least partially, shifted treatment from clinician-supervised hospital care to patient-managed home regimens. However, patients with breast cancer receiving oral cyclin-dependent kinase 4/6 inhibitor therapy still require regular hospital visits to monitor side effects. Telemonitoring has the potential to reduce hospital visits while maintaining quality care. Objective: This study aims to develop a digital home-based health care center (DHHC) for acquiring electrocardiograms (ECGs), white blood cell (WBC) counts, side effect photo documentation, and patient-reported quality of life (QoL) data. Methods: The DHHC was set up using an Apple Watch Series 6 (ECG measurements), a HemoCue WBC DIFF Analyzer (WBC counts), an iPhone SE (QoL assessments and photo documentation), a TP-Link M7350-4G Wi-Fi router, and a Raspberry Pi 4 Model B. A custom-built app stored and synchronized remotely collected data with the clinic. The feasibility and acceptance of the DHHC among patients with breast cancer undergoing cyclin-dependent kinase 4/6 inhibitor therapy were evaluated in a prospective, single-arm, monocentric study. Patients (n=76) monitored side effects---ECGs, WBC counts, photo documentation, and QoL---at 3 predefined time points: study inclusion (on-site), day 14 (remote), and day 28 (remote). After the study completion, patients completed a comprehensive questionnaire on user perception and feasibility. Adherence to scheduled visits, the success rate of the data transfer, user perception and feasibility, and the clinical relevance of remote measurements were evaluated. Results: Mean adherence to the planned remote visits was 63\% on day 14 and 37\% on day 28. ECG measurements were performed most frequently (day 14: 57/76, 75\%; day 28: 31/76, 41\%). The primary patient-reported reason for nonadherence was device malfunction. The expected versus the received data transfer per patient was as follows: ECGs: 3 versus 3.04 (SD 1.9); WBC counts: 3 versus 2.14 (SD 1.14); QoL questionnaires: 3 versus 2.5 (SD 1.14); and photo documentation: 6 versus 4.4 (SD 3.36). Among patients, 81\% (55/68) found ECG measurements easy, 82\% (55/67) found photo documentation easy, and 48\% (33/69) found WBC measurements easy. Additionally, 61\% (40/66) of patients felt comfortable with self-monitoring and 79\% (54/68) were willing to integrate remote monitoring into their future cancer care. Therapy-induced decreased neutrophil count was successfully detected (P<.001; mean baseline: 4.3, SD 2.2, {\texttimes}109/L; on-treatment: 1.8, SD 0.8, {\texttimes}109/L). All-grade neutropenia and corrected QT interval prolongations were detected in 80\% (55/68) and 2\% (1/42) of patients, respectively. Conclusions: Adherence to scheduled remote visits was moderate, with nonadherence primarily attributed to device-related complications, which may have also affected the success rate of data transfer. Overall, patients considered remote monitoring useful and feasible. The prevalence of reported adverse events was comparable to existing literature, suggesting clinical potential. This initial feasibility study highlights the potential of the DHHC. ",
doi="10.2196/64083",
url="https://cancer.jmir.org/2025/1/e64083"
}


@Article{info:doi/10.2196/60169,
author="Mu{\~n}oz Olivar, Carolina
and Pineiro, Miguel
and G{\'o}mez Quintero, Sebasti{\'a}n Juan
and Avenda{\~n}o-V{\'a}squez, Javier Carlos
and Orme{\~n}o-Arriagada, Pablo
and Palma Rivadeneira, Silvia
and Taramasco Toro, Carla",
title="Education and Symptom Reporting in an mHealth App for Patients With Cancer: Mixed Methods Development and Validation Study",
journal="JMIR Hum Factors",
year="2025",
month="Apr",
day="28",
volume="12",
pages="e60169",
keywords="cancer",
keywords="patient-reported outcome measures",
keywords="software design",
keywords="unpleasant symptom",
keywords="toxicity",
keywords="mHealth",
keywords="mobile health",
keywords="surveys and questionnaires",
keywords="application",
keywords="design",
keywords="evaluation",
keywords="chemotherapy",
keywords="health care communication",
keywords="mixed methods",
keywords="validation",
keywords="efficiency",
keywords="security",
abstract="Background: The widespread prevalence of cancer across the globe demands cutting-edge solutions for its treatment. Current cancer therapies, notably chemotherapy, pose challenges due to their side effects. The early detection and management of the side effects are vital but complex. This study introduces a mobile health app designed to bridge the communication gaps between patients with cancer and health care providers. Hence, it allows patients to report symptoms immediately and also enables proactive symptom management by health care providers. Objective: This study has 2 objectives: first, to design a cancer-focused mobile health app that integrates educational content and real-time symptom reporting for chemotherapy patients. Second, to validate and evaluate the app quality using the Mobile App Rating Scale (MARS). The app seeks to foster health care communication, reduce hospital readmissions, and optimize symptom management, contributing to a more impactful patient experience. Methods: This mixed-methods study details the development and validation of mobile health applications. The app was designed by a multidisciplinary team, including nurses, medical professionals, pharmaceutical chemists, computer engineers, and software developers, using agile methodologies. For validation, the app was assessed by 13 evaluators, including clinical professionals (nurses and physicians) and engineers. The evaluation included technical performance analysis using Google tools and quality assessment using the MARS, which measures engagement, functionality, aesthetics, and information quality. Results: Performance metrics highlighted areas for improvement, with loading times showing delays in displaying content. Meanwhile, the response time of the app was moderate, and visual stability remained excellent. The app achieved an overall MARS score of 3.75 (SD 0.42), indicating consistent quality, with functionality scoring the highest (4.35; SD 0.52) and engagement the lowest (3.31; SD 0.61). The reliability of the MARS was confirmed (interclass correlation coefficient: 0.84; 95\% CI: 0.72?0.92). Evaluators unanimously praised the app's potential benefits for patients and clinical professionals while identifying areas for improvement such as customization, onboarding guidance, and navigation. Conclusions: The CONTIGO app showed strengths in functionality, usability, and information quality, supported by robust security measures. However, areas such as user interactivity and engagement require improvement. Future refinements will integrate insights from patients with cancer to address user-specific needs and enhance the oncology care experience. ",
doi="10.2196/60169",
url="https://humanfactors.jmir.org/2025/1/e60169"
}


@Article{info:doi/10.2196/67767,
author="Chan, Fan-Ying
and Ku, Yi-En
and Lie, Wen-Nung
and Chen, Hsiang-Yin",
title="Web-Based Explainable Machine Learning-Based Drug Surveillance for Predicting Sunitinib- and Sorafenib-Associated Thyroid Dysfunction: Model Development and Validation Study",
journal="JMIR Form Res",
year="2025",
month="Apr",
day="10",
volume="9",
pages="e67767",
keywords="thyroid dysfunction",
keywords="machine learning",
keywords="cancer",
keywords="sunitinib",
keywords="sorafenib",
keywords="TKI",
keywords="tyrosine kinase inhibitor",
abstract="Background: Unlike one-snap data collection methods that only identify high-risk patients, machine learning models using time-series data can predict adverse events and aid in the timely management of cancer. Objective: This study aimed to develop and validate machine learning models for sunitinib- and sorafenib-associated thyroid dysfunction using a time-series data collection approach. Methods: Time series data of patients first prescribed sunitinib or sorafenib were collected from a deidentified clinical research database. Logistic regression, random forest, adaptive Boosting, Light Gradient-Boosting Machine, and Gradient Boosting Decision Tree were used to develop the models. Prediction performances were compared using the accuracy, precision, recall, F1-score, area under the receiver operating characteristic curve, and area under the precision-recall curve. The optimal threshold for the best-performing model was selected based on the maximum F1-score. SHapley Additive exPlanations analysis was conducted to assess feature importance and contributions at both the cohort and patient levels. Results: The training cohort included 609 patients, while the temporal validation cohort had 198 patients. The Gradient Boosting Decision Tree model without resampling outperformed other models, with area under the precision-recall curve of 0.600, area under the receiver operating characteristic curve of 0.876, and F1-score of 0.583 after adjusting the threshold. The SHapley Additive exPlanations analysis identified higher cholesterol levels, longer summed days of medication use, and clear cell adenocarcinoma histology as the most important features. The final model was further integrated into a web-based application. Conclusions: This model can serve as an explainable adverse drug reaction surveillance system for predicting sunitinib- and sorafenib-associated thyroid dysfunction. ",
doi="10.2196/67767",
url="https://formative.jmir.org/2025/1/e67767"
}


@Article{info:doi/10.2196/69743,
author="?arkovi{\'c}, Ma{\vs}a
and Schindera, Christina
and Sommer, Grit
and Schneider, Christine
and Usemann, Jakob
and Otth, Maria
and L{\"u}er, Sonja
and Ansari, Marc
and Latzin, Philipp
and Kuehni, E. Claudia",
title="Assessing Pulmonary Function in Children and Adolescents After Cancer Treatment: Protocol for a Multicenter Cohort Study (Swiss Childhood Cancer Survivor Study FollowUp--Pulmo)",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="8",
volume="14",
pages="e69743",
keywords="childhood cancer survivors",
keywords="respiratory function tests",
keywords="late effects",
keywords="pulmonary toxicity",
keywords="multiple breath washout test",
keywords="cohort study",
abstract="Background: Childhood cancer survivors (CCS) are at risk of pulmonary dysfunction due to cancer treatments, but evidence on prevalence and risk factors remains limited. Most previous studies had small sample sizes or retrospective study designs, little information about treatments, or a lack of standardization of pulmonary function tests (PFTs) or limited their investigation to certain PFTs. Since spirometry mainly assesses the large airways but cancer therapy also affects peripheral airways, additional functional tests are needed. The nitrogen multiple breath washout test (N2MBW) is sensitive to peripheral airway damage in other patient populations, but its benefit in CCS is unknown. Therefore, comprehensive and standardized evaluation of pulmonary function after cancer treatment in childhood, using different PFTs that include N2MBW, is needed to address these knowledge gaps and provide insights into possible early stages of pulmonary dysfunction. Objective: In the Swiss Childhood Cancer Survivor Study (SCCSS) FollowUp--Pulmo, we will comprehensively assess lung function in children and adolescents after treatment for cancer to identify risk factors for pulmonary dysfunction, assess the ability of N2MBW to detect pulmonary dysfunction compared to other PFTs, and investigate the association of functional outcomes from PFTs with self-reported respiratory symptoms. Methods: SCCSS FollowUp--Pulmo is a prospective multicenter longitudinal cohort study embedded in routine clinical care that enrolls CCS aged 6-20 years for whom at least 1 year has passed since a childhood cancer diagnosis, who have completed treatment, and who attend regular pediatric oncological follow-up care. Inclusion criteria comprise any of the following: systemic anticancer treatment (chemotherapy, immunotherapy, or targeted agents), thoracic surgery, thoracic radiotherapy, or hematopoietic stem cell transplantation (HSCT). CCS undergo a standardized pulmonary assessment, including spirometry, body plethysmography, diffusing capacity of the lung for carbon monoxide (DLCO), and N2MBW, and complete a questionnaire on respiratory symptoms and lifestyle. Data from previous and subsequent routine care PFTs will be included in this study. Results: Recruitment started in June 2022 at the University Children's Hospital Bern, Switzerland. Subsequently, patient recruitment expanded to the University Children's Hospitals in Basel and Geneva, Switzerland. By October 2024, we had invited 220 patients, of which 201 have already participated in this study, resulting in a response rate of 91\%. Their median age at the time of the study was 14 years (IQR 10-17), and the median time since diagnosis was 7 years (IQR 4-10). The study will continuously enroll new CCS. Conclusions: This study will contribute to a comprehensive understanding of pulmonary function in CCS and assess related risk factors, as well as the utility of N2MBW compared to other PFTs. The results will assist in the development of more targeted screening and risk-stratified follow-up care. Trial Registration: ClinicalTrials.gov NCT04732273; https://clinicaltrials.gov/study/NCT04732273 International Registered Report Identifier (IRRID): DERR1-10.2196/69743 ",
doi="10.2196/69743",
url="https://www.researchprotocols.org/2025/1/e69743"
}


@Article{info:doi/10.2196/68179,
author="Rades, Dirk
and K{\"u}ter, Jan-Dirk
and von Staden, Michael
and Al-Salool, Ahmed
and Janssen, Stefan
and Timke, Carmen
and Duma, Nona Marciana
and Bartscht, Tobias
and Vesterg{\aa}rd Madsen, Christine
and Kristiansen, Charlotte
and Cremers, Florian",
title="A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With  Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="8",
volume="14",
pages="e68179",
keywords="prostate cancer",
keywords="external beam radiation therapy",
keywords="radiation toxicity",
keywords="bladder filling",
keywords="mobile app",
abstract="Background: Many patients with nonmetastatic prostate cancer receive radiotherapy, which may be associated with acute cystitis, particularly if the volume of the urinary bladder is small. Three studies showed bladder volumes <200 ml or <180 ml to be associated with increased urinary toxicity. Therefore, it is important to maintain bladder volumes greater than 200 ml during as many radiation fractions as possible. Several studies investigated drinking protocols, where patients were asked to drink a certain amount of water prior to radiotherapy sessions. This may require considerable discipline from the patients, who are predominantly older adults. Adherence to a drinking protocol may be facilitated by a mobile app that reminds patients to drink water prior to each radiation session. This study investigates the effect of such an app on bladder filling status in patients with prostate cancer undergoing external beam radiotherapy (EBRT) alone. Objective: The primary goal of this study is to evaluate the impact of an app that reminds patients irradiated for prostate cancer to drink 300 ml of water prior to each radiotherapy session on the number of fractions with bladder volumes <200 ml during the radiotherapy course. Methods: This ongoing phase 2 aims to recruit 28 patients treated with EBRT alone for nonmetastatic prostate cancer. Radiotherapy will be administered using normo-fractionation, with doses ranging from 70 to 80 Gy in 35 to 40 fractions of 2 Gy, preferably with volumetric-modulated arc therapy (VMAT). Treatment volumes include the prostate with or without the seminal vesicles. Results: Recruitment for this trial will start in March 2025 and is planned to be completed in October 2026. The study is scheduled to conclude in December 2026. Conclusions: This trial is the first to evaluate the impact of a reminder app on the number of radiotherapy fractions with bladder volumes <200 ml in patients undergoing irradiation for localized prostate cancer. Trial Registration: Clinicaltrials.gov NCT06653751; https://clinicaltrials.gov/show/NCT06653751 International Registered Report Identifier (IRRID): PRR1-10.2196/68179 ",
doi="10.2196/68179",
url="https://www.researchprotocols.org/2025/1/e68179"
}


@Article{info:doi/10.2196/67108,
author="Lin, Chen Yu
and Hagen, Ryan
and Powers, D. Benjamin
and Dineen, P. Sean
and Milano, Jeanine
and Hume, Emma
and Sprow, Olivia
and Diaz-Carraway, Sophia
and Permuth, B. Jennifer
and Deneve, Jeremiah
and Alishahi Tabriz, Amir
and Turner, Kea",
title="Digital Health Intervention to Reduce Malnutrition Among Individuals With Gastrointestinal Cancer Receiving Cytoreductive Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy: Feasibility, Acceptability, and Usability Trial",
journal="JMIR Cancer",
year="2025",
month="Apr",
day="7",
volume="11",
pages="e67108",
keywords="gastrointestinal cancer",
keywords="peritoneal disease",
keywords="cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy",
keywords="digital health intervention",
keywords="nutrition",
keywords="feasibility",
abstract="Background: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) can improve survival outcomes for individuals with gastrointestinal (GI) cancer and peritoneal disease (PD). Individuals with GI cancer and PD receiving CRS-HIPEC are at increased risk for malnutrition. Despite the increased risk for malnutrition, there has been limited study of nutritional interventions for individuals receiving CRS-HIPEC. Objective: We aimed to test the feasibility, acceptability, and usability of Support Through Remote Observation and Nutrition Guidance (STRONG), a multilevel digital health intervention to improve nutritional management among individuals with GI cancer and PD receiving CRS-HIPEC. We also assessed patient-reported outcomes, including malnutrition risk, health-related quality of life, and weight-related measures. Methods: STRONG is a 12-week digital intervention in which participants received biweekly nutritional counseling with a dietitian, logged food intake using a Fitbit tracker, and reported nutrition-related outcomes. Dietitians received access to a web-based dashboard and remotely monitored patients' reported food intake and nutrition-impact symptoms. Implementation outcomes were assessed against prespecified benchmarks consistent with benchmarks used in prior studies. Changes in patient-reported outcomes at baseline and follow-up were assessed using linear and ordered logistic regressions. Results: Participants (N=10) had a median age of 57.5 (IQR 54-69) years. Feasibility benchmarks were achieved for recruitment (10/17, 59\% vs benchmark: 50\%), study assessment completion (9/10, 90\% vs benchmark: 60\%), dietitian appointment attendance (7/10, 70\% vs benchmark: 60\%), daily food intake logging adherence (6/10, 60\% vs benchmark: 60\%), and participant retention (10/10, 100\% vs benchmark: 60\%). Most participants rated the intervention as acceptable (8/10, 80\% vs benchmark: 70\%) and reported a high level of usability for dietitian services (10/10, 100\%). The benchmark usability for the Fitbit tracker to log food intake was not met. Compared to baseline, participants saw on average a 6.0 point reduction in malnutrition risk score (P=.01), a 20.5 point improvement in general health-related quality of life score (P=.002), and a 5.6 percentage point increase in 1-month weight change (P=.04) at the end of the study. Conclusions: The STRONG intervention demonstrated to be feasible, acceptable, and usable among individuals with GI cancer and PD receiving CRS-HIPEC. A fully powered randomized controlled trial is needed to test the effectiveness of STRONG for reducing malnutrition and improving patient outcomes. Trial Registration: ClinicalTrials.gov NCT05649969; https://clinicaltrials.gov/study/NCT05649969 ",
doi="10.2196/67108",
url="https://cancer.jmir.org/2025/1/e67108"
}


@Article{info:doi/10.2196/62749,
author="Iivanainen, Sanna
and Arokoski, Reetta
and Mentu, Santeri
and Lang, Laura
and Ekstr{\"o}m, Jussi
and Virtanen, Henri
and Kataja, Vesa
and Koivunen, Pekka Jussi",
title="Development of a Comprehensive Decision Support Tool for Chemotherapy-Cycle Prescribing: Initial Usability Study",
journal="JMIR Form Res",
year="2025",
month="Mar",
day="31",
volume="9",
pages="e62749",
keywords="cancer",
keywords="chemotherapy",
keywords="ePRO",
keywords="electronic patient-reported outcome",
keywords="decision support system",
abstract="Background: Chemotherapy cycle prescription is generally carried out through a multistep manual process that is prone to human error. Clinical decision support tools can provide patient-specific assessments that support clinical decisions, improve prescribing practices, and reduce medication errors. Objective: We hypothesized that a knowledge-based, patient-derived, evidence-directed decision support tool consisting of multiple modules focusing on the core duties preceding chemotherapy-cycle prescription could result in a more cost-effective and error-free approach and streamline the workflow. Methods: A 1-arm, multicenter, prospective clinical trial (``Follow-up of Cancer Patients Receiving Chemotherapy or Targeted Therapy by Electronic Patient Reported Outcomes-tool'' [ECHO] 7/2019-1/2021; NCT04081558) was initiated to investigate the tool. The most important inclusion criteria were the presence of colorectal cancer (CRC) treated with oxaliplatin-based chemotherapy, age ?18 years, Eastern Cooperative Oncology Group [ECOG] performance score of 0 to 2, and internet access. A decision support tool that included digital symptom monitoring, a laboratory value interface, and treatment schedule integration for semiautomated chemotherapy cycle prescribing was integrated into the care pathway. Performance was assessed by the percentage of chemotherapy cycles with sent and completed symptom questionnaires, while perceptions of health care professionals (HCPs) on the feasibility of the approach were collected through a 1-time semistructured interview. Results: The ECHO trial included 43 patients with CRC treated with doublet or triplet chemotherapy in an adjuvant or metastatic setting. Altogether, 843 electronic patient-reported outcome (ePRO) symptom questionnaires were completed. Of the 15 recorded symptoms, fatigue (n=446, 52.9\%) and peripheral neuropathy (n=429, 50.9\%) were reported most often, while 137 grade 3 to 4 symptoms were recorded, of which diarrhea (n=5, 4\%) and peripheral neuropathy (n=4, 3\%) were the most common. During the study, 339 chemotherapy cycles were prescribed, and for the 77\% (n=262) of new chemotherapy cycles, ePRO questionnaire data were available within preset limits (completed within 3 days prior to chemotherapy scheduling) while 65\% of the cycles (n=221) had symptom questionnaire grading at ?1\%, and 67\% of the cycles (n=228) had laboratory values in a preset range. The recommendations by the tool for a new chemotherapy cycle were tier 1 (green; meaning ``go'') in 145 (42.8\%) of the cycles, tier 2 (yellow; ``evaluate'') in 83 (25\%), and tier 3 (red; ``hold'') in 111 (32.7\%). HCPs (n=3) were interviewed with a questionnaire (comprising 8 questions), revealing that they most valued the improved workflow, faster patient evaluation, and direct messaging option. Conclusions: In this study, we investigated the feasibility of a decision support system for chemotherapy-cycle pre-evaluation and prescription that was developed for the prospective ECHO trial. The study showed that the functionalities of the investigated tool were feasible and that an automated approach to chemotherapy-cycle prescription was possible for nearly half of the cycles. Trial Registration: ClinicalTrials.gov NCT04081558; https://clinicaltrials.gov/study/NCT04081558 ",
doi="10.2196/62749",
url="https://formative.jmir.org/2025/1/e62749"
}


@Article{info:doi/10.2196/66275,
author="Minvielle, Etienne
and Perez-Torrents, Joel
and Salma, Israa
and Aegerter, Philippe
and Ferrua, Marie
and Fert{\'e}, Charles
and Leleu, Henri
and Mathivon, Delphine
and Sicotte, Claude
and Di Palma, Mario
and Scott{\'e}, Florian",
title="The Effect of Nurse Navigators in Digital Remote Monitoring in Cancer Care: Case Study Using Structural Equation Modeling",
journal="J Med Internet Res",
year="2025",
month="Mar",
day="28",
volume="27",
pages="e66275",
keywords="digital remote monitoring",
keywords="nurse navigators",
keywords="patient care",
keywords="oncology",
keywords="toxicity",
keywords="patient satisfaction",
keywords="hospitalization",
abstract="Background: The purpose of digital remote monitoring (DRM) is improving cancer care management. However, its effectiveness largely depends on the role of nurse navigators (NNs) within these systems to process data and lead action. Objective: This study aims to fill gaps in our understanding of the role of NNs within a specific system, drawing on the Canc{\'e}rologie parcours r{\'e}gion Ile-de-France (CAPRI) DRM program applied to oncology patients. Methods: The CAPRI DRM, targeting patients taking oral anticancer agents, combines digital interfaces with NN interventions. A phase 3 randomized controlled trial involving 559 patients assessed its safety and efficacy, with the primary end point being the relative dose intensity. This report focuses on patients in the CAPRI arm, evaluating the impact of NN interventions on outcomes such as toxicity, hospitalization, and emergency visits. Data on patient characteristics, NN interventions, and patient satisfaction surveys were analyzed using structural equation modeling. Results: The study included 187 patients. Patient characteristics were significantly correlated with outcomes. Across all the models we used, the quality of NN interventions was consistently associated with higher patient satisfaction, with correlation coefficients ranging from 0.332 (95\% CI 0.154-0.510; P<.001) to 0.366 (95\% CI 0.182-0.550; P<.001). The number of grade ?3 toxicity events correlated positively with NN referrals to oncologists. Hospitalization length was positively related to NN referral (coefficient 0.102, 95\% CI 0.051-0.153; P<.001) and inversely to NN advice (coefficient --0.045, 95\% CI --0.096 to 0.006; P=.08). Emergency visits showed a negative correlation with NN actions (coefficient --0.478, 95\% CI --0.923 to 0.033; P=.04) and a positive correlation with NN calls and referrals (coefficient 0.516, 95\% CI 0.069-0.963; P=.02). Conclusions: This study shows the central role of NNs in making DRM effective. Despite the study's limitations, these results support the design of DRM as a hybrid model of automated digital tools and human support. Future research should explore the applicability of such a DRM model in various clinical settings to clarify the optimal association between automated systems and NN expertise. Trial Registration: ClinicalTrials.gov NCT02828462; https://www.clinicaltrials.gov/study/NCT02828462 ",
doi="10.2196/66275",
url="https://www.jmir.org/2025/1/e66275"
}


@Article{info:doi/10.2196/55475,
author="Ahmed, Saima
and Maheu, Christine
and Gotlieb, Walter
and Batist, Gerald
and Loiselle, G. Carmen",
title="Feasibility, Acceptability, and Potential Effects of a Digital Oral Anticancer Agent Intervention: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="26",
volume="14",
pages="e55475",
keywords="oral anticancer agent",
keywords="supportive intervention",
keywords="medication adherence",
keywords="cancer",
keywords="oncology",
keywords="feasibility",
keywords="acceptability",
keywords="digital health",
keywords="anticancer",
keywords="adherence",
keywords="compliance",
keywords="RCT",
keywords="randomized controlled trial",
keywords="drug",
keywords="pharmacy",
keywords="pharmacology",
keywords="pharmacotherapy",
keywords="pharmaceutic",
keywords="pharmaceutical",
keywords="medication",
keywords="mobile phone",
abstract="Background: Individuals taking oral anticancer agents (OAAs) often face important challenges, requiring more timely informational support, ongoing monitoring, and side effect management. Objective: This study, guided by the Self-Efficacy Theory, aims to assess the feasibility, acceptability, and potential effects of a comprehensive, digital OAA intervention. Methods: A 2-arm, mixed methods, pilot randomized controlled trial took place at a large university-affiliated cancer center in Montreal, Quebec, Canada. Participants (N=52) completed baseline self-report e-questionnaires and subsequently were randomly assigned to the experimental group (intervention plus usual care, n=26) or control group (usual care only, n=26). The study intervention, designed to increase medication adherence via medication adherence self-efficacy and decreased symptom distress, included (1) OAA informational videos, (2) OAA-related e-handouts and other supportive resources, (3) nurse-led follow-up calls, and (4) e-reminders to take OAAs. The e-questionnaires were completed once a week for the first month and every 2 weeks for the subsequent 4 months, or until OAA treatment was completed. A subset from both groups (n=20) participated in semistructured interviews once they completed the study requirements. Study feasibility is assessed using recruitment, retention, and response rates, as well as intervention uptake. Through e-questionnaires and exit interviews, intervention acceptability is to be assessed prospectively at baseline and retrospectively upon study completion. Potential effects are then assessed via medication adherence self-efficacy, medication adherence self-report, and symptom distress. Results: Data collection was completed by December 2023 with a final sample size of 41. Results are expected to be published in 2025. Conclusions: This study relies on a theoretically based, OAA digital intervention with modalities tailored to the needs and preferences of participants. The use of quantitative and qualitative methods enriches our understanding of the potential contributions of the intervention. In addition, following participants over the course of treatment captures potential changes in oral treatment--related processes and outcomes. Trial Registration: ClinicalTrials.gov NCT04984850; https://www.clinicaltrials.gov/study/nct04984850 International Registered Report Identifier (IRRID): DERR1-10.2196/55475 ",
doi="10.2196/55475",
url="https://www.researchprotocols.org/2025/1/e55475"
}


@Article{info:doi/10.2196/60588,
author="Carr, L. Alaina
and Jenkins, M. Angela
and Jonklaas, Jacqueline
and Gabriel, Kate
and Miller, E. Kristen
and Graves, D. Kristi",
title="Patient and Provider Perspectives of a Web-Based Intervention to Support Symptom Management After Radioactive Iodine Treatment for Differentiated Thyroid Cancer: Qualitative Study",
journal="JMIR Form Res",
year="2025",
month="Mar",
day="19",
volume="9",
pages="e60588",
keywords="iodine radioisotopes",
keywords="person-based approach",
keywords="self-management",
keywords="Social Cognitive Theory",
keywords="survivorship",
keywords="symptom burden",
keywords="thyroid neoplasms",
keywords="web-based intervention",
keywords="radioactive iodine treatment",
keywords="radiotherapy",
keywords="thyroid cancer",
keywords="qualitative",
keywords="quality of life",
keywords="survivorship care",
keywords="supportive care",
keywords="patient with cancer",
keywords="QoL",
keywords="cancer",
keywords="carcinoma",
keywords="malignancy",
keywords="tumor",
keywords="malignant",
keywords="oncology",
keywords="neoplasm",
keywords="benign",
keywords="neoplasia",
keywords="thyroid",
abstract="Background: Patients diagnosed with differentiated thyroid cancer (DTC) who receive radioactive iodine (RAI) treatment experience acute, medium, and late treatment effects. The timing and severity of these effects vary by individual; common posttreatment effects include dry mouth, salivary gland swelling, dry eyes, and nose bleeds. The nature of symptoms that patients experience after RAI treatment can significantly and negatively impact health-related quality of life. Adequate information during the postprimary treatment phase remains an unmet need among the population of patients diagnosed with DTC. Objective: This qualitative study aimed to identify and understand self-management strategies for RAI-specific symptom burden from the perspectives of patients and stakeholders (cancer care providers and patient advocates). An additional aim included assessing features and functionalities desirable in the development of a web-based intervention to engage patients in their self-management and thyroid cancer survivorship care. Methods: Following the Social Cognitive Theory framework and person-based principles, we conducted six focus groups with 22 patients diagnosed with DTC who completed RAI treatment and individual interviews with 12 stakeholders in DTC care. The interviews focused on participants' perspectives on current self-management strategies and mockups of a symptom management web-based intervention. Before focus groups and interviews, participants completed a demographics survey. Focus group discussions and interviews were transcribed and coded using content analysis. Interrater reliability was satisfactory (?=.88). Results: A total of 34 individuals (patients and stakeholders) participated in the study; the mean age was 45 (SD 13.4) and 45.3 (SD 13) years, respectively. Three domains emerged from qualitative interviews: (1) difficult-to-manage RAI symptoms: short, medium, and late treatment effects; (2) key intervention structure and content feedback on mockups; and (3) intervention content to promote RAI symptom management and survivorship care. Focus group participants identified the most prevalent RAI symptoms that were difficult to manage as: dry mouth (11/22, 50\%), salivary gland swelling (8/22, 36\%), and changes in taste (12/22, 55\%). Feedback elicited from both groups found education and symptom management mockup videos to be helpful in patient self-management of RAI symptoms, whereas patients and stakeholders provided mixed feedback on the benefits of a draft frequently asked questions page. Across focus groups and stakeholder interviews, nutrition-based symptom management strategies, communication with family members, and practical survivorship follow-up information emerged as helpful content to include in a future web-based supportive care intervention. Conclusions: Results suggest education and symptom management videos can empower patients with DTC to self-manage mild to moderate RAI symptoms on a web-based platform. Findings emphasized the need for additional information for patients related to ongoing care following RAI treatment including social support and thyroid cancer surveillance. The findings provide insights for theoretically informed interventions and recommendations for refinements in thyroid cancer survivorship from patient and provider perspectives. ",
doi="10.2196/60588",
url="https://formative.jmir.org/2025/1/e60588"
}


@Article{info:doi/10.2196/63891,
author="Garc{\'i}a-Molina, Jennifer
and Saiz-V{\'a}zquez, Olalla
and Santamar{\'i}a-V{\'a}zquez, Montserrat
and Ortiz-Huerta, Hilario Juan",
title="Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Patients With Breast Cancer: Protocol for a Randomized Clinical Trial",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="12",
volume="14",
pages="e63891",
keywords="breast cancer",
keywords="exercise",
keywords="quality of life",
keywords="muscle strength",
keywords="pain",
keywords="efficacy",
keywords="protocol",
keywords="physical exercise",
keywords="fatigue",
keywords="loss of muscle",
keywords="physical function",
keywords="randomized clinical trial",
keywords="patients with cancer",
abstract="Background: Breast cancer is the second most common cancer in women worldwide. Treatments for this disease often result in side effects such as pain, fatigue, loss of muscle mass, and reduced quality of life. Physical exercise has been shown to effectively mitigate these side effects and improve the quality of life in patients with breast cancer. Objective: This randomized clinical trial aims to evaluate the efficacy of a 12-week supervised exercise program on pain, physical function, and quality of life in female patients with cancer. Methods: This randomized, double-blind clinical trial will recruit 325 participants, divided into an intervention group receiving the exercise program and a control group receiving standard care recommendations. Outcome measures, including pain (assessed via the Brief Pain Inventory), physical function (Disability of the Arm, Shoulder, and Hand Questionnaire), and quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 and European Organization for Research and Treatment of Cancer QLQ-BR23), will be evaluated at baseline, immediately post intervention, and 12 weeks post intervention. Statistical analysis will involve repeated measures of ANOVA and MANOVA to determine the significance of the intervention's effects across time points. Results: Recruitment and data collection will commence in February of 2025, and data analysis is scheduled for completion at the end of 2025. No results are currently available Conclusions: Physical exercise is anticipated to play a significant role in alleviating pain, enhancing physical function, and improving the quality of life in female patients with cancer. This study will provide robust evidence to support the integration of supervised exercise into standard care protocols for this population. Trial Registration: ClinicalTrials.gov NCT06618690; https://clinicaltrials.gov/ct2/show/NCT06618690 International Registered Report Identifier (IRRID): PRR1-10.2196/63891 ",
doi="10.2196/63891",
url="https://www.researchprotocols.org/2025/1/e63891"
}


@Article{info:doi/10.2196/69663,
author="Yanagisawa, Yuki
and Watabe, Satoshi
and Yokoyama, Sakura
and Sayama, Kyoko
and Kizaki, Hayato
and Tsuchiya, Masami
and Imai, Shungo
and Someya, Mitsuhiro
and Taniguchi, Ryoo
and Yada, Shuntaro
and Aramaki, Eiji
and Hori, Satoko",
title="Identifying Adverse Events in Outpatients With Prostate Cancer Using Pharmaceutical Care Records in Community Pharmacies: Application of Named Entity Recognition",
journal="JMIR Cancer",
year="2025",
month="Mar",
day="11",
volume="11",
pages="e69663",
keywords="natural language processing",
keywords="pharmaceutical care records",
keywords="androgen receptor axis-targeting agents",
keywords="adverse events",
keywords="outpatient care",
abstract="Background: Androgen receptor axis-targeting reagents (ARATs) have become key drugs for patients with castration-resistant prostate cancer (CRPC). ARATs are taken long term in outpatient settings, and effective adverse event (AE) monitoring can help prolong treatment duration for patients with CRPC. Despite the importance of monitoring, few studies have identified which AEs can be captured and assessed in community pharmacies, where pharmacists in Japan dispense medications, provide counseling, and monitor potential AEs for outpatients prescribed ARATs. Therefore, we anticipated that a named entity recognition (NER) system might be used to extract AEs recorded in pharmaceutical care records generated by community pharmacists. Objective: This study aimed to evaluate whether an NER system can effectively and systematically identify AEs in outpatients undergoing ARAT therapy by reviewing pharmaceutical care records generated by community pharmacists, focusing on assessment notes, which often contain detailed records of AEs. Additionally, the study sought to determine whether outpatient pharmacotherapy monitoring can be enhanced by using NER to systematically collect AEs from pharmaceutical care records. Methods: We used an NER system based on the widely used Japanese medical term extraction system MedNER-CR-JA, which uses Bidirectional Encoder Representations from Transformers (BERT). To evaluate its performance for pharmaceutical care records by community pharmacists, the NER system was first applied to 1008 assessment notes in records related to anticancer drug prescriptions. Three pharmaceutically proficient researchers compared the results with the annotated notes assigned symptom tags according to annotation guidelines and evaluated the performance of the NER system on the assessment notes in the pharmaceutical care records. The system was then applied to 2193 assessment notes for patients prescribed ARATs. Results: The F1-score for exact matches of all symptom tags between the NER system and annotators was 0.72, confirming the NER system has sufficient performance for application to pharmaceutical care records. The NER system automatically assigned 1900 symptom tags for the 2193 assessment notes from patients prescribed ARATs; 623 tags (32.8\%) were positive symptom tags (symptoms present), while 1067 tags (56.2\%) were negative symptom tags (symptoms absent). Positive symptom tags included ARAT-related AEs such as ``pain,'' ``skin disorders,'' ``fatigue,'' and ``gastrointestinal symptoms.'' Many other symptoms were classified as serious AEs. Furthermore, differences in symptom tag profiles reflecting pharmacists' AE monitoring were observed between androgen synthesis inhibition and androgen receptor signaling inhibition. Conclusions: The NER system successfully extracted AEs from pharmaceutical care records of patients prescribed ARATs, demonstrating its potential to systematically track the presence and absence of AEs in outpatients. Based on the analysis of a large volume of pharmaceutical medical records using the NER system, community pharmacists not only detect potential AEs but also actively monitor the absence of severe AEs, offering valuable insights for the continuous improvement of patient safety management. ",
doi="10.2196/69663",
url="https://cancer.jmir.org/2025/1/e69663"
}


@Article{info:doi/10.2196/64016,
author="Fekete, Tibor J{\'a}nos
and Gy?rffy, Bal{\'a}zs",
title="MetaAnalysisOnline.com: Web-Based Tool for the Rapid Meta-Analysis of Clinical and Epidemiological Studies",
journal="J Med Internet Res",
year="2025",
month="Mar",
day="6",
volume="27",
pages="e64016",
keywords="statistics",
keywords="pharmacology",
keywords="treatment",
keywords="epidemiology",
keywords="fixed effect model",
keywords="random effect model",
keywords="hazard rate",
keywords="response rate",
keywords="clinical trial",
keywords="funnel plot",
keywords="z score plot",
abstract="Background: A meta-analysis is a quantitative, formal study design in epidemiology and clinical medicine that systematically integrates and quantitatively synthesizes findings from multiple independent studies. This approach not only enhances statistical power but also enables the exploration of effects across diverse populations and helps resolve controversies arising from conflicting studies. Objective: This study aims to develop and implement a user-friendly tool for conducting meta-analyses, addressing the need for an accessible platform that simplifies the complex statistical procedures required for evidence synthesis while maintaining methodological rigor. Methods: The platform available at MetaAnalysisOnline.com enables comprehensive meta-analyses through an intuitive web interface, requiring no programming expertise or command-line operations. The system accommodates diverse data types including binary (total and event numbers), continuous (mean and SD), and time-to-event data (hazard rates with CIs), while implementing both fixed-effect and random-effect models using established statistical approaches such as DerSimonian-Laird, Mantel-Haenszel, and inverse variance methods for effect size estimation and heterogeneity assessment. Results: In addition to statistical tests, graphical representations including the forest plot, the funnel plot, and the z score plot can be drawn. A forest plot is highly effective in illustrating heterogeneity and pooled results. The risk of publication bias can be revealed by a funnel plot. A z score plot provides a visual assessment of whether more research is needed to establish a reliable conclusion. All the discussed models and visualization options are integrated into the registration-free web-based portal. Leveraging MetaAnalysisOnline.com's capabilities, we examined treatment-related adverse events in patients with cancer receiving perioperative anti--PD-1 immunotherapy through a systematic review encompassing 10 studies with 8099 total participants. Meta-analysis revealed that anti--PD-1 therapy doubled the risk of adverse events (risk ratio 2.15, 95\% CI 1.39-3.32), with significant between-study heterogeneity (I2=95\%) and publication bias detected through the Egger test (P=.02). While these findings suggest increased toxicity associated with anti--PD-1 treatment, the z score analysis indicated that additional studies are needed for definitive conclusions. Conclusions: In summary, the web-based tool aims to bridge the void for clinical and life science researchers by offering a user-friendly alternative for the swift and reproducible meta-analysis of clinical and epidemiological trials. ",
doi="10.2196/64016",
url="https://www.jmir.org/2025/1/e64016",
url="http://www.ncbi.nlm.nih.gov/pubmed/39928123"
}


@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/10.2196/60948,
author="Wu, Xingyue
and Lam, Sing Chun
and Hui, Ho Ka
and Loong, Ho-fung Herbert
and Zhou, Rui Keary
and Ngan, Chun-Kit
and Cheung, Ting Yin",
title="Perceptions in 3.6 Million Web-Based Posts of Online Communities on the Use of Cancer Immunotherapy: Data Mining Using BERTopic",
journal="J Med Internet Res",
year="2025",
month="Feb",
day="10",
volume="27",
pages="e60948",
keywords="social media",
keywords="cancer",
keywords="immunotherapy",
keywords="perceptions",
keywords="data mining",
keywords="oncology",
keywords="web-based",
keywords="lifestyle",
keywords="therapeutic intervention",
keywords="leukemia",
keywords="lymphoma",
keywords="survival",
keywords="treatment",
keywords="health information",
keywords="decision-making",
keywords="online community",
keywords="machine learning",
abstract="Background: Immunotherapy has become a game changer in cancer treatment. The internet has been used by patients as a platform to share personal experiences and seek medical guidance. Despite the increased utilization of immunotherapy in clinical practice, few studies have investigated the perceptions about its use by analyzing social media data. Objective: This study aims to use BERTopic (a topic modeling technique that is an extension of the Bidirectional Encoder Representation from Transformers machine learning model) to explore the perceptions of online cancer communities regarding immunotherapy. Methods: A total of 4.9 million posts were extracted from Facebook, Twitter, Reddit, and 16 online cancer-related forums. The textual data were preprocessed by natural language processing. BERTopic modeling was performed to identify topics from the posts. The effectiveness of isolating topics from the posts was evaluated using 3 metrics: topic diversity, coherence, and quality. Sentiment analysis was performed to determine the polarity of each topic and categorize them as positive or negative. Based on the topics generated through topic modeling, thematic analysis was conducted to identify themes associated with immunotherapy. Results: After data cleaning, 3.6 million posts remained for modeling. The highest overall topic quality achieved by BERTopic was 70.47\% (topic diversity: 87.86\%; topic coherence: 80.21\%). BERTopic generated 14 topics related to the perceptions of immunotherapy. The sentiment score of around 0.3 across the 14 topics suggested generally positive sentiments toward immunotherapy within the online communities. Six themes were identified, primarily covering (1) hopeful prospects offered by immunotherapy, (2) perceived effectiveness of immunotherapy, (3) complementary therapies or self-treatments, (4) financial and mental impact of undergoing immunotherapy, (5) impact on lifestyle and time schedules, and (6) side effects due to treatment. Conclusions: This study provides an overview of the multifaceted considerations essential for the application of immunotherapy as a therapeutic intervention. The topics and themes identified can serve as supporting information to facilitate physician-patient communication and the decision-making process. Furthermore, this study also demonstrates the effectiveness of BERTopic in analyzing large amounts of data to identify perceptions underlying social media and online communities. ",
doi="10.2196/60948",
url="https://www.jmir.org/2025/1/e60948"
}


@Article{info:doi/10.2196/65615,
author="Chen, Ciao-Sin
and Dorsch, P. Michael
and Alsomairy, Sarah
and Griggs, J. Jennifer
and Jagsi, Reshma
and Sabel, Michael
and Stino, Amro
and Callaghan, Brian
and Hertz, L. Daniel",
title="Remote Monitoring of Chemotherapy-Induced Peripheral Neuropathy by the NeuroDetect iOS App: Observational Cohort Study of Patients With Cancer",
journal="J Med Internet Res",
year="2025",
month="Feb",
day="5",
volume="27",
pages="e65615",
keywords="chemotherapy-induced peripheral neuropathy",
keywords="smartphone",
keywords="mobile health",
keywords="gait",
keywords="balance",
keywords="manual dexterity",
keywords="mobile phone",
keywords="chemotherapy",
keywords="peripheral neuropathy",
keywords="CIPN",
keywords="neurotoxic chemotherapy",
keywords="monitoring",
keywords="detection",
keywords="patient-reported outcomes",
keywords="mHealth",
keywords="application",
abstract="Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating adverse effect of neurotoxic chemotherapy characterized by symptoms such as numbness, tingling, and weakness. Effective monitoring and detection of CIPN are crucial for avoiding progression to irreversible symptoms. Due to the inconvenience of clinic-based objective assessment, CIPN detection relies primarily on patients' reporting of subjective symptoms, and patient-reported outcomes are used to facilitate CIPN detection. Our previous study found evidence that objective functional assessments completed within a smartphone app may differentiate patients with and those without CIPN after treatment. Objective: This prospective, longitudinal observational cohort study aimed to determine the feasibility and accuracy of app-based remote monitoring of CIPN in patients with cancer undergoing neurotoxic chemotherapeutic treatment and to conduct exploratory comparisons of app-based functional CIPN monitoring versus patient-reported outcome--only monitoring. Methods: The NeuroDetect app (Medable Inc) includes subjective EORTC (European Organization for Research and Treatment of Cancer) Quality of Life Questionnaire (QLQ)--20-item scale (CIPN20) and 6 objective functional assessments that use smartphone sensors to mimic neurological examinations, such as walking, standing, and manual dexterity tests. The functional assessment data were collected from patients with cancer undergoing neurotoxic chemotherapy, and a neurological examination was conducted at the end of treatment to diagnose CIPN in the feet (CIPN-f) or CIPN in the hands (CIPN-h). Various classification models including NeuroDetect features only (NeuroDetect Model) CIPN20-only (CIPN20 Model) or a combination of both (Combined Model) were trained and evaluated for accuracy in predicting CIPN probability. Results: Of the 45 patients who completed functional assessments and neurological examinations, 24 had CIPN-f, and 29 had CIPN-h. The NeuroDetect Model could discriminate between patients with and those without CIPN-f (area under the curve=83.8\%, comparison with no information rate P=.02) but not CIPN-h (area under the curve=67.9\%, P=.18). The rolling rotation features from the eyes-closed phase of the Romberg Stance assessment showed the greatest contribution to CIPN-f (40\% of total variable importance) and the Finger Tapping assessment showed the greatest contribution to CIPN-h (85\% of total variable importance). The NeuroDetect Model had numerically, and at some time points statistically, superior performance to the CIPN20 Model in both CIPN-f and CIPN-h, particularly before and early in treatment. The Combined Model numerically, though not statistically, outperformed either assessment strategy individually, indicating that the combination of functional and patient-reported assessment within a smartphone may be optimal to CIPN detection. Conclusions: Our findings demonstrate the feasibility of integrating subjective and objective CIPN assessment into a smartphone app for remote, longitudinal CIPN monitoring. Studies of larger patient cohorts are needed to refine the app-based CIPN detection models and determine whether their use in practice improves CIPN detection. ",
doi="10.2196/65615",
url="https://www.jmir.org/2025/1/e65615"
}


@Article{info:doi/10.2196/58938,
author="Fraterman, Itske
and Sacchi, Lucia
and Mallo, Henk
and Tibollo, Valentina
and Glaser, Catherina Savannah Lucia
and Medlock, Stephanie
and Cornet, Ronald
and Gabetta, Matteo
and Hisko, Vitali
and Khadakou, Vadzim
and Barkan, Ella
and Del Campo, Laura
and Glasspool, David
and Kogan, Alexandra
and Lanzola, Giordano
and Leizer, Roy
and Ottaviano, Manuel
and Peleg, Mor
and ?niata?a, Konrad
and Lisowska, Aneta
and Wilk, Szymon
and Parimbelli, Enea
and Quaglini, Silvana
and Rizzo, Mimma
and Locati, Deborah Laura
and Boekhout, Annelies
and van de Poll-Franse, V. Lonneke
and Wilgenhof, Sofie",
title="Exploring the Impact of the Multimodal CAPABLE eHealth Intervention on Health-Related Quality of Life in Patients With Melanoma Undergoing Immune-Checkpoint Inhibition: Prospective Pilot Study",
journal="JMIR Cancer",
year="2025",
month="Jan",
day="30",
volume="11",
pages="e58938",
keywords="eHealth",
keywords="melanoma",
keywords="cancer",
keywords="fatigue",
keywords="quality of life",
keywords="intervention",
keywords="pilot study",
keywords="exploratory",
keywords="health-related",
keywords="interventions",
keywords="symptom",
keywords="monitoring",
keywords="well-being",
keywords="immunotherapy",
keywords="immune-related",
keywords="immune-checkpoint inhibitor",
keywords="patient",
keywords="feasibility",
keywords="smartphone",
keywords="app",
keywords="smartwatch",
keywords="linear regression model",
keywords="mobile phone",
abstract="Background: Patients with melanoma receiving immunotherapy with immune-checkpoint inhibitors often experience immune-related adverse events, cancer-related fatigue, and emotional distress, affecting health-related quality of life (HRQoL) and clinical outcome to immunotherapy. eHealth tools can aid patients with cancer in addressing issues, such as adverse events and psychosocial well-being, from various perspectives. Objective: This study aimed to explore the effect of the Cancer Patients Better Life Experience (CAPABLE) system, accessed through a mobile app, on HRQoL compared with a matched historical control group receiving standard care. CAPABLE is an extensively tested eHealth app, including educational material, remote symptom monitoring, and well-being interventions. Methods: This prospective pilot study compared an exploratory cohort that received the CAPABLE smartphone app and a multisensory smartwatch for 6 months (intervention) to a 2:1 individually matched historical prospective control group. HRQoL data were measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 at baseline (T0), 3 months (T1), and 6 months (T2) after start of treatment. Mixed effects linear regression models were used to compare HRQoL between the 2 groups over time. Results: From the 59 eligible patients for the CAPABLE intervention, 31 (53\%) signed informed consent to participate. Baseline HRQoL was on average 10 points higher in the intervention group compared with controls, although equally matched on baseline and clinical characteristics. When correcting for sex, age, disease stage, and baseline scores, an adjusted difference in fatigue of ?5.09 (95\% CI ?15.20 to 5.02, P=.32) at month 3 was found. No significant nor clinically relevant adjusted differences on other HRQoL domains over time were found. However, information satisfaction was significantly higher in the CAPABLE group ($\beta$=8.71, 95\% CI 1.54?15.88, P=.02). Conclusions: The intervention showed a limited effect on HRQoL, although there was a small improvement in fatigue at 3 months, as well as information satisfaction. When aiming at personalized patient and survivorship care, further optimization and prospective investigation of eHealth tools is warranted. Trial Registration: ClinicalTrials NCT05827289; https://clinicaltrials.gov/study/NCT05827289 International Registered Report Identifier (IRRID): RR2-10.2196/49252 ",
doi="10.2196/58938",
url="https://cancer.jmir.org/2025/1/e58938"
}


@Article{info:doi/10.2196/57659,
author="Glaser, Caterina Savannah Lucia
and Fraterman, Itske
and van Brummelen, Noah
and Tibollo, Valentina
and Del Campo, Maria Laura
and Mallo, Henk
and Wilgenhof, Sofie
and Wilk, Szymon
and Gisko, Vitali
and Khadakou, Vadzim
and Cornet, Ronald
and Ottaviano, Manuel
and Medlock, Stephanie",
title="Usability and Usefulness of a Symptom Management Coaching System for Patients With Cancer Treated With Immune Checkpoint Inhibitors: Comparative Mixed Methods Study",
journal="JMIR Form Res",
year="2025",
month="Jan",
day="23",
volume="9",
pages="e57659",
keywords="oncology",
keywords="usability",
keywords="usefulness",
keywords="symptom management",
keywords="coaching system",
keywords="patients with cancer",
keywords="immune checkpoint inhibitors",
keywords="comparative qualitative study",
keywords="medication",
keywords="eHealth applications",
keywords="caregivers",
keywords="cancer treatment",
keywords="patient education",
keywords="well-being interventions",
keywords="acceptability",
keywords="melanoma",
keywords="renal cell carcinoma",
keywords="immunotherapy",
abstract="Background: The prognosis for patients with several types of cancer has substantially improved following the introduction of immune checkpoint inhibitors, a novel type of immunotherapy. However, patients may experience symptoms both from the cancer itself and from the medication. A prototype of the eHealth tool Cancer Patients Better Life Experience (CAPABLE) was developed to facilitate symptom management, aimed at patients with melanoma and renal cell carcinoma treated with immunotherapy. Better usability of such eHealth tools can lead to improved user well-being and reduced risk of harm. It is unknown for usability evaluations whether certain usability problems would only be evident to patients whose condition closely resembles the target population, or if a broader group of patients would lead to the identification of a broader range of potential usability issues. Objective: This study aims to evaluate the CAPABLE prototype by conducting tests to assess usability, user experience, and perceived acceptability among end users, and to assess any agreements or differences in the results of our wide range of participants. Methods: This usability study was executed by interviewing participants with a melanoma or renal cell carcinoma diagnosis who have received immunotherapy and participants without direct experience with the targeted cancer types who have not received immunotherapy. Participants were asked to review the concept of the tool, perform think-aloud tasks, and complete the System Usability Scale and a Perceived Usefulness questionnaire. Usability problems were extracted from the interview data by independent coding and mapped to an eHealth Usability Problem Framework. Results: We included 21 participants in the study, aged 29 to 73 years; 13 participants who had received immunotherapy and 8 participants who had not received immunotherapy. In total, 76 usability problems were identified. A total of 22 usability problems were in the task-technology fit category of the usability framework, mostly regarding the coaching and symptom functionality of the prototype. Critical problems regarding the symptom monitoring functionality were mainly found by participants who had received immunotherapy. For 8 out of 10 statements in the Perceived Usefulness questionnaire, more than 75\% of participants agreed or strongly agreed. The overall mean System Usability Scale score was 80 out of 100 (SD 11.3). Conclusions: Despite identified usability issues, participants responded positively to the Perceived Usefulness questionnaire regarding the evaluated tool. Further analysis of the usability problems indicates that it was essential to include participants who matched the target end users. Participants treated with immunotherapy, specifically with previous experience in immune-related adverse events, encountered critical problems with symptom reporting that would not have been identified if these participants were not included. For other tasks and functionalities, it seems likely that loosening the inclusion criteria would have resulted in sufficient feedback without critical missing usability issues. ",
doi="10.2196/57659",
url="https://formative.jmir.org/2025/1/e57659"
}


@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/10.2196/62711,
author="Bartel, Christianna
and Chen, Leeann
and Huang, Weiyu
and Li, Qichang
and Li, Qingyang
and Fedor, Jennifer
and Durica, C. Krina
and Low, A. Carissa",
title="Design and Use of Patient-Facing Electronic Patient-Reported Outcomes and Sensor Data Visualizations During Outpatient Chemotherapy",
journal="JMIR Cancer",
year="2025",
month="Jan",
day="10",
volume="11",
pages="e62711",
keywords="oncology",
keywords="cancer",
keywords="data visualization",
keywords="remote monitoring",
keywords="mobile technology",
keywords="patients",
keywords="outpatient",
keywords="chemotherapy",
keywords="symptoms",
keywords="side effects",
keywords="cancer treatment",
keywords="electronic patient-reported outcome",
keywords="online",
keywords="monitoring",
keywords="self-management",
doi="10.2196/62711",
url="https://cancer.jmir.org/2025/1/e62711"
}


@Article{info:doi/10.2196/55300,
author="Peerawong, Thanarpan
and Phenwan, Tharin
and Makita, Meiko
and Supanichwatana, Sojirat
and Puttarak, Panupong
and Siammai, Naowanit
and Sunthorn, Prakaidao",
title="Evaluating Online Cannabis Health Information for Thai Breast Cancer Survivors Using the Quality Evaluation Scoring Tool (QUEST): Mixed Method Study",
journal="JMIR Cancer",
year="2024",
month="Dec",
day="24",
volume="10",
pages="e55300",
keywords="cannabis",
keywords="medical cannabis",
keywords="Thailand",
keywords="critical discourse analysis",
keywords="mixed method study",
keywords="breast cancer",
keywords="digital literacy",
keywords="legislation",
keywords="health literacy",
abstract="Background: Following medical cannabis legalization in Thailand in 2019, more people are seeking medical cannabis--related information, including women living with breast cancer. The extent to which they access cannabis-related information from internet sources and social media platforms and the quality of such content are relatively unknown and need further evaluation. Objective: This study aims to analyze the factors determining cannabis-related content quality for breast cancer care from internet sources and on social media platforms and examine the characteristics of such content accessed and consumed by Thai breast cancer survivors. Methods: A mixed methods study was conducted between January 2021 and May 2022, involving a breast cancer survivor support group. The group identified medical cannabis--related content from frequently accessed internet sources and social media platforms. The contents were categorized based on content creators, platforms, content category, and upload dates. Four researchers used the Quality Evaluation Scoring Tool (QUEST) to assess content quality, with scores ranging from 0 to 28. Contents were expert-rated as either high or poor. The QUEST interobserver reliability was analyzed. Receiver-operating characteristic curve analysis with the Youden index was used to determine the QUEST score cut-off point. Statistical significance was set at P<.05. Fairclough Critical Discourse Analysis was undertaken to examine the underlying discourses around poor-quality content. Results: Sixty-two Thai-language cannabis-related items were evaluated. The content sources were categorized as follows: news channels (21/62, 34\%), government sources (16/62, 26\%), health care providers (12/62, 19\%), and alternative medicine providers (12/62, 19\%). Most of the contents (30/62, 48\%) were uploaded to YouTube, whereas 31\% (19/62) appeared on websites and Facebook. Forty of 62 content items (64\%) were news-related and generic cannabis advertisements while 8 of 62 (13\%) content items had no identifiable date. The interobserver QUEST score correlation was 0.86 (P<.001). The mean QUEST score was 12.1 (SD 7.6). Contents were considered ``high'' when the expert rating was >3. With a QUEST score of 15 as the threshold, the sensitivity and specificity for differentiating between high and poor content quality were 81\% and 98\%, respectively. Content creation was the only significant factor between high- and poor-quality content. Poor-quality contents were primarily created by alternative medicine providers and news channels. Two discourses were identified: advocacy for cannabis use normalization and cannabis romanticization as a panacea. These discourses overly normalize and romanticize the use of cannabis, focusing on indications and instructions for cannabis use, and medical cannabis promotion, while neglecting discussions on cannabis contraindications and potential side effects. Conclusions: The varying quality of medical cannabis--related information on internet sources and social media platforms accessed and shared by Thai breast cancer survivors is an issue of concern. Given that content creators are the sole predictive factors of high content quality, future studies should examine a wider range of cannabis-related sources accessible to both the public and patients to gain a more comprehensive understanding of the issue. ",
doi="10.2196/55300",
url="https://cancer.jmir.org/2024/1/e55300"
}


@Article{info:doi/10.2196/53834,
author="McCann, Lisa
and Lewis, Liane
and Oduntan, Olubukola
and Harris, Jenny
and Darley, Andrew
and Berg, V. Geir
and Lubowitzki, Simone
and Cheevers, Katy
and Miller, Morven
and Armes, Jo
and Ream, Emma
and Fox, Patricia
and Furlong, Patricia Eileen
and Gaiger, Alexander
and Kotronoulas, Grigorios
and Patiraki, Elisabeth
and Katsaragakis, Stylianos
and McCrone, Paul
and Miaskowski, Christine
and Cardone, Antonella
and Orr, Dawn
and Flowerday, Adrian
and Skene, Simon
and Moore, Margaret
and De Souza, Nicosha
and Donnan, Peter
and Maguire, Roma",
title="Patients' and Clinicians' Experiences Using a Real-Time Remote Monitoring System for Chemotherapy Symptom Management (ASyMS): Qualitative Study",
journal="J Med Internet Res",
year="2024",
month="Dec",
day="3",
volume="26",
pages="e53834",
keywords="cancer",
keywords="clinician experiences",
keywords="digital interventions",
keywords="patient experiences",
keywords="remote monitoring",
keywords="qualitative methods",
abstract="Background: Patients receiving chemotherapy require ongoing symptom monitoring and management to optimize their outcomes. In recent years, digital remote monitoring interventions have emerged to provide enhanced cancer care delivery experiences to patients and clinicians. However, patient and clinician experiential evaluations of these technologies are rare. Therefore, we explored user experiences and perceptions of one such intervention---Advanced Symptom Management System (ASyMS)---after its scaled deployment in the context of the Electronic Symptom Management System Remote Technology (eSMART) trial. The eSMART trial was a large, multicenter randomized controlled trial to evaluate the efficacy of ASyMS in 12 clinical sites in 5 European countries. Objective: In this qualitative study, both patients' and clinicians' experiences of using ASyMS for up to 6 cycles of chemotherapy were explored to understand the impact of ASyMS on patients' experiences, clinical practice, and supportive care delivery. Methods: For this analysis, individual, semistructured, one-to-one interviews with 29 patients with breast, colorectal, and hematological cancers and 18 clinicians from Austria, Greece, Ireland, Norway, and the United Kingdom were conducted. Interviews focused on patients' and clinicians' experiences of using ASyMS, care organization and changes in practice following the introduction of ASyMS, perceived changes in care associated with the use of ASyMS, and its potential for future integration into routine chemotherapy care pathways. Results: Thematic analysis identified several themes that describe patients' and clinicians' experiences using ASyMS. One central orienting theme---ASyMS as a facilitator of change---was supported by 5 key themes associated with human and technology monitoring: reassurance, enhanced communications and relationships, knowing what is ``normal'' and what is to be expected, enhancing cancer care experiences, and informing future cancer care. Conclusions: This study is the first to evaluate both patients' and clinicians' experiences of using a digital health intervention to remotely monitor chemotherapy symptoms across 5 countries. Experiences with ASyMS were positive from both patients' and clinicians' perspectives, although some improvements to support the wider-scale rollout and sustained implementation were identified. Overall, this study demonstrates that real-time remote monitoring systems can help patients feel more reassured during their chemotherapy treatments and can help clinicians provide the right care, at the right time, and in the right place. Trial Registration: ClinicalTrials.gov NCT02356081; https://clinicaltrials.gov/study/NCT02356081 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2016-015016 ",
doi="10.2196/53834",
url="https://www.jmir.org/2024/1/e53834"
}


@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/10.2196/64406,
author="Chow, L. James C.
and Li, Kay",
title="Ethical Considerations in Human-Centered AI: Advancing Oncology Chatbots Through Large Language Models",
journal="JMIR Bioinform Biotech",
year="2024",
month="Nov",
day="6",
volume="5",
pages="e64406",
keywords="artificial intelligence",
keywords="humanistic AI",
keywords="ethical AI",
keywords="human-centered AI",
keywords="machine learning",
keywords="large language models",
keywords="natural language processing",
keywords="oncology chatbot",
keywords="transformer-based model",
keywords="ChatGPT",
keywords="health care",
doi="10.2196/64406",
url="https://bioinform.jmir.org/2024/1/e64406",
url="http://www.ncbi.nlm.nih.gov/pubmed/39321336"
}


@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/10.2196/64673,
author="Loerzel, Victoria
and Alamian, Arsham
and Clochesy, John
and Geddie, I. Patricia",
title="Serious Gaming for Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer: Protocol for a Randomized Clinical Trial",
journal="JMIR Res Protoc",
year="2024",
month="Oct",
day="2",
volume="13",
pages="e64673",
keywords="chemotherapy-induced nausea and vomiting",
keywords="aged",
keywords="serious game",
keywords="symptom self-management",
keywords="mobile phone",
keywords="neoplasms",
keywords="self-care",
abstract="Background: Older adults are at high risk for toxicity due to cancer treatment and increased risk for adverse events related to chemotherapy-induced nausea and vomiting (CINV). Unfortunately, older adults report multiple treatment-related symptoms but use few strategies to self-manage these symptoms due to erroneous beliefs related to the effectiveness of commonly taught self-management strategies. We developed a novel serious game, Managing at Home (MAH), to help older adults learn how to effectively self-manage CINV at home. Objective: This study has 2 aims. Aim 1 is to examine changes in CINV severity, self-management behaviors, functioning, quality of life, cognitive representation, and health care use within the intervention group from baseline (T1) to completion of the study (T6). Aim 2 is to determine the efficacy of the MAH intervention by comparing differences in primary outcomes (CINV severity and health care use) and secondary outcomes (self-management behaviors, functioning, and quality of life) between the intervention and control groups at each follow-up visit (T2-T6) and completion of the study (T6). Methods: This is a longitudinal randomized clinical trial. We will collect data from 500 older adults receiving cancer-related chemotherapy at baseline (T1) and at each treatment cycle until cycle 6 (T6). Participants will be enrolled if they are 60 years or older of age, are newly diagnosed with cancer, being treated with any chemotherapy agent with moderate or high emetic potential, are on a 2-, 3-, or 4-week treatment cycle, are proficient in English, and have a telephone. Previous diagnosis or treatment for cancer, end-stage disease with less than 6 months to live, and uncorrected visual or hearing impairment are exclusion criteria. Results: This study was funded in September 2022 and received institutional review board approval in October 2022. As of July 2023, the enrollment of participants is ongoing and currently has 130 enrolled participants. Data collection and analysis will be complete in 2027. Conclusions: This study addresses self-management of CINV in older adults using an innovative serious game. The MAH intervention uses simulation and gaming technology to engage older adults in active learning in order to reframe erroneous perceptions about symptom self-management. If shown to be effective, it can easily be adapted to include other cancer-related symptoms or other chronic illnesses. Trial Registration: ClinicalTrials.gov NCT05838638; https://clinicaltrials.gov/study/NCT05838638 International Registered Report Identifier (IRRID): DERR1-10.2196/64673 ",
doi="10.2196/64673",
url="https://www.researchprotocols.org/2024/1/e64673"
}


@Article{info:doi/10.2196/56935,
author="McLoughlin, E. Daniel
and Moreno Echevarria, M. Fabiola
and Badawy, M. Sherif",
title="Lessons Learned From Shared Decision-Making With Oral Anticoagulants: Viewpoint on Suggestions for the Development of Oral Chemotherapy Decision Aids",
journal="JMIR Cancer",
year="2024",
month="Sep",
day="11",
volume="10",
pages="e56935",
keywords="shared decision-making",
keywords="SDM",
keywords="decision aids",
keywords="decision aids design",
keywords="oral chemotherapy",
keywords="oral anticoagulants",
keywords="drug delivery",
keywords="chemotherapy",
keywords="chemo",
keywords="anticoagulants",
keywords="drug deliveries",
keywords="cancer",
keywords="oncology",
keywords="oncologist",
keywords="metastases",
keywords="literature review",
keywords="literature reviews",
doi="10.2196/56935",
url="https://cancer.jmir.org/2024/1/e56935",
url="http://www.ncbi.nlm.nih.gov/pubmed/39187430"
}


@Article{info:doi/10.2196/54740,
author="Islam, Nazmul
and Reuben, S. Jamie
and Dale, Justin
and Coates, W. James
and Sapiah, Karan
and Markson, R. Frank
and Jordan, T. Craig
and Smith, Clay",
title="Predictive Models for Long Term Survival of AML Patients Treated with Venetoclax and Azacitidine or 7+3 Based on Post Treatment Events and Responses: Retrospective Cohort Study",
journal="JMIR Cancer",
year="2024",
month="Aug",
day="21",
volume="10",
pages="e54740",
keywords="Leukemia, Myeloid, Acute",
keywords="Venetoclax",
keywords="Azacitidine",
keywords="Anthracycline",
keywords="Arabinoside, Cytosine",
keywords="Clinical Decision Support",
keywords="Clinical Informatics",
keywords="Machine Learning",
keywords="Predictive Model",
keywords="Overall Survival",
abstract="Background: The treatment of acute myeloid leukemia (AML) in older or unfit patients typically involves a regimen of venetoclax plus azacitidine (ven/aza). Toxicity and treatment responses are highly variable following treatment initiation and clinical decision-making continually evolves in response to these as treatment progresses. To improve clinical decision support (CDS) following treatment initiation, predictive models based on evolving and dynamic toxicities, disease responses, and other features should be developed. Objective: This study aims to generate machine learning (ML)--based predictive models that incorporate individual predictors of overall survival (OS) for patients with AML, based on clinical events occurring after the initiation of ven/aza or 7+3 regimen. Methods: Data from 221 patients with AML, who received either the ven/aza (n=101 patients) or 7+3 regimen (n=120 patients) as their initial induction therapy, were retrospectively analyzed. We performed stratified univariate and multivariate analyses to quantify the association between toxicities, hospital events, and short-term disease responses and OS for the 7+3 and ven/aza subgroups separately. We compared the estimates of confounders to assess potential effect modifications by treatment. 17 ML-based predictive models were developed. The optimal predictive models were selected based on their predictability and discriminability using cross-validation. Uncertainty in the estimation was assessed through bootstrapping. Results: The cumulative incidence of posttreatment toxicities varies between the ven/aza and 7+3 regimen. A variety of laboratory features and clinical events during the first 30 days were differentially associated with OS for the two treatments. An initial transfer to intensive care unit (ICU) worsened OS for 7+3 patients (aHR 1.18, 95\% CI 1.10-1.28), while ICU readmission adversely affected OS for those on ven/aza (aHR 1.24, 95\% CI 1.12-1.37). At the initial follow-up, achieving a morphologic leukemia free state (MLFS) did not affect OS for ven/aza (aHR 0.99, 95\% CI 0.94-1.05), but worsened OS following 7+3 (aHR 1.16, 95\% CI 1.01-1.31) compared to that of complete remission (CR). Having blasts over 5\% at the initial follow-up negatively impacted OS for both 7+3 (P<.001) and ven/aza (P<.001) treated patients. A best response of CR and CR with incomplete recovery (CRi) was superior to MLFS and refractory disease after ven/aza (P<.001), whereas for 7+3, CR was superior to CRi, MLFS, and refractory disease (P<.001), indicating unequal outcomes. Treatment-specific predictive models, trained on 120 7+3 and 101 ven/aza patients using over 114 features, achieved survival AUCs over 0.70. Conclusions: Our findings indicate that toxicities, clinical events, and responses evolve differently in patients receiving ven/aza compared with that of 7+3 regimen. ML-based predictive models were shown to be a feasible strategy for CDS in both forms of AML treatment. If validated with larger and more diverse data sets, these findings could offer valuable insights for developing AML-CDS tools that leverage posttreatment clinical data. ",
doi="10.2196/54740",
url="https://cancer.jmir.org/2024/1/e54740"
}


@Article{info:doi/10.2196/60828,
author="Selles, Lima William de
and Miyamoto, Cristiane Gisela
and Santos, Concei{\c{c}}{\~a}o Elinaldo da
and Carmo, Lima Cibelle Regina
and Moura, Marini Giovanni
and Santos, Frascoli Giovanna Marques
and Lopes, Santos Giovanna dos
and Silva, Wisnieski Diego
and Pereira, Ferreira Leticia Jeremias
and Lunardi, Claudia Adriana",
title="Effectiveness of Aerobic Training for Adverse Symptoms Related to Chemotherapy During Treatment: Protocol for a Randomized Controlled Trial With Cost-Effectiveness Assessment",
journal="JMIR Res Protoc",
year="2024",
month="Aug",
day="20",
volume="13",
pages="e60828",
keywords="cancer",
keywords="exercise",
keywords="chemotherapy",
keywords="physical therapy",
keywords="cost benefit analyses",
keywords="economic evaluation",
abstract="Background: One strategy to prevent adverse effects resulting from chemotherapy treatment is to perform physical exercises during treatment. However, there is still no consensus on the best type and intensity of exercise, nor when it should be started. Most studies have been carried out in patients with breast cancer, usually a few weeks after starting chemotherapy, on an outpatient basis 2 to 3 times a week. The main differences in our study are that we carried out physical training in hospitalized patients undergoing a cycle of chemotherapy for cancer treatment and that this training was carried out 5 times a week and was not restricted to a specific type of cancer. Objective: We aimed to evaluate the effects of aerobic training on symptoms related to chemotherapy (nausea, vomiting, asthenia, and sensation of weakness), fatigue, mobility, clinical complications, and length of hospital stay of patients during the drug treatment cycle. We also evaluated patient satisfaction with the proposed intervention, the adverse effects of aerobics training, and the cost-effectiveness of this intervention. Methods: This is a controlled and randomized trial with blinded evaluation that will include 94 hospitalized patients with cancer for 1 or more cycles of chemotherapy. The intervention group will perform aerobic training during a cycle of chemotherapy. The control group will receive a booklet with guidelines for staying active during the hospitalization period. The groups will be compared using a linear mixed model for fatigue, mobility, and chemotherapy-related symptoms before and after the intervention. The length of hospital stay will also be compared between groups using Kaplan-Meier survival analysis. The incidence of complications will be compared using the $\chi$2 test. Cost-effectiveness and cost-utility analyses will be performed for the impact of exercise and quality-adjusted life years with the EQ-5D-3L-21 quality of life trials. The implementation variables (acceptability, suitability, and feasibility) will be evaluated by frequencies. Results: The clinical trial registration was approved in March 2023. Recruitment and data collection for the trial are ongoing, and the results of this study are likely to be published in late 2025. Conclusions: Chemotherapy has side effects that negatively impact the quality of life of patients with cancer. Aerobic exercise can reduce these side effects in a simple and inexpensive way. The field of work of physical therapists could be expanded to oncology if the intervention works. Trial Registration: Registro Brasileiro de Ensaios Cl{\'i}nicos RBR-6b4zwx3; https://tinyurl.com/39c4c7wz International Registered Report Identifier (IRRID): DERR1-10.2196/60828 ",
doi="10.2196/60828",
url="https://www.researchprotocols.org/2024/1/e60828",
url="http://www.ncbi.nlm.nih.gov/pubmed/39163116"
}


@Article{info:doi/10.2196/51381,
author="Aye, Sin Phyu
and Barnes, Joanne
and Laking, George
and Cameron, Laird
and Anderson, Malcolm
and Luey, Brendan
and Delany, Stephen
and Harris, Dean
and McLaren, Blair
and Brenman, Elliott
and Wong, Jayden
and Lawrenson, Ross
and Arendse, Michael
and Tin Tin, Sandar
and Elwood, Mark
and Hope, Philip
and McKeage, James Mark",
title="Erlotinib or Gefitinib for Treating Advanced Epidermal Growth Factor Receptor Mutation--Positive Lung Cancer in Aotearoa New Zealand: Protocol for a National Whole-of-Patient-Population Retrospective Cohort Study and Results of a Validation Substudy",
journal="JMIR Res Protoc",
year="2024",
month="Jul",
day="2",
volume="13",
pages="e51381",
keywords="epidermal growth factor receptor",
keywords="erlotinib",
keywords="gefitinib",
keywords="lung cancer",
keywords="retrospective cohort",
keywords="study protocol",
keywords="validation",
abstract="Background: Starting in 2010, the epidermal growth factor receptor (EGFR) kinase inhibitors erlotinib and gefitinib were introduced into routine use in Aotearoa New Zealand (NZ) for treating advanced lung cancer, but their impact in this setting is unknown. Objective: The study described in this protocol aims to understand the effectiveness and safety of these new personalized lung cancer treatments and the contributions made by concomitant medicines and other factors to adverse outcomes in the general NZ patient population. A substudy aimed to validate national electronic health databases as the data source and the methods for determining patient eligibility and identifying outcomes and variables. Methods: This study will include all NZ patients with advanced EGFR mutation--positive lung cancer who were first dispensed erlotinib or gefitinib before October 1, 2020, and followed until death or for at least 1 year. Routinely collected health administrative and clinical data will be collated from national electronic cancer registration, hospital discharge, mortality registration, and pharmaceutical dispensing databases by deterministic data linkage using National Health Index numbers. The primary effectiveness and safety outcomes will be time to treatment discontinuation and serious adverse events, respectively. The primary variable will be high-risk concomitant medicines use with erlotinib or gefitinib. For the validation substudy (n=100), data from clinical records were compared to those from national electronic health databases and analyzed by agreement analysis for categorical data and by paired 2-tailed t tests for numerical data. Results: In the validation substudy, national electronic health databases and clinical records agreed in determining patient eligibility and for identifying serious adverse events, high-risk concomitant medicines use, and other categorical data with overall agreement and $\kappa$ statistic of >90\% and >0.8000, respectively; for example, for the determination of patient eligibility, the comparison of proxy and standard eligibility criteria applied to national electronic health databases and clinical records, respectively, showed overall agreement and $\kappa$ statistic of 96\% and 0.8936, respectively. Dates for estimating time to treatment discontinuation and other numerical variables and outcomes showed small differences, mostly with nonsignificant P values and 95\% CIs overlapping with zero difference; for example, for the dates of the first dispensing of erlotinib or gefitinib, national electronic health databases and clinical records differed on average by approximately 4 days with a nonsignificant P value of .33 and 95\% CIs overlapping with zero difference. As of May 2024, the main study is ongoing. Conclusions: A protocol is presented for a national whole-of-patient-population retrospective cohort study designed to describe the safety and effectiveness of erlotinib and gefitinib during their first decade of routine use in NZ for treating EGFR mutation--positive lung cancer. The validation substudy demonstrated the feasibility and validity of using national electronic health databases and the methods for determining patient eligibility and identifying the study outcomes and variables proposed in the study protocol. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615000998549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368928 International Registered Report Identifier (IRRID): DERR1-10.2196/51381 ",
doi="10.2196/51381",
url="https://www.researchprotocols.org/2024/1/e51381"
}


@Article{info:doi/10.2196/51059,
author="Manz, R. Christopher
and Schriver, Emily
and Ferrell, J. William
and Williamson, Joelle
and Wakim, Jonathan
and Khan, Neda
and Kopinsky, Michael
and Balachandran, Mohan
and Chen, Jinbo
and Patel, S. Mitesh
and Takvorian, U. Samuel
and Shulman, N. Lawrence
and Bekelman, E. Justin
and Barnett, J. Ian
and Parikh, B. Ravi",
title="Association of Remote Patient-Reported Outcomes and Step Counts With Hospitalization or Death Among Patients With Advanced Cancer Undergoing Chemotherapy: Secondary Analysis of the PROStep Randomized Trial",
journal="J Med Internet Res",
year="2024",
month="May",
day="17",
volume="26",
pages="e51059",
keywords="wearables",
keywords="accelerometers",
keywords="patient-reported outcomes",
keywords="step counts",
keywords="oncology",
keywords="accelerometer",
keywords="patient-generated health data",
keywords="cancer",
keywords="death",
keywords="chemotherapy",
keywords="symptoms",
keywords="gastrointestinal cancer",
keywords="lung cancer",
keywords="monitoring",
keywords="symptom burden",
keywords="risk",
keywords="hospitalization",
keywords="mobile phone",
abstract="Background: Patients with advanced cancer undergoing chemotherapy experience significant symptoms and declines in functional status, which are associated with poor outcomes. Remote monitoring of patient-reported outcomes (PROs; symptoms) and step counts (functional status) may proactively identify patients at risk of hospitalization or death. Objective: The aim of this study is to evaluate the association of (1) longitudinal PROs with step counts and (2) PROs and step counts with hospitalization or death. Methods: The PROStep randomized trial enrolled 108 patients with advanced gastrointestinal or lung cancers undergoing cytotoxic chemotherapy at a large academic cancer center. Patients were randomized to weekly text-based monitoring of 8 PROs plus continuous step count monitoring via Fitbit (Google) versus usual care.?This preplanned secondary analysis included 57 of 75 patients randomized to the intervention who had PRO and step count data. We analyzed the associations between PROs and mean daily step counts and the associations of PROs and step counts with the composite outcome of hospitalization or death using bootstrapped generalized linear models to account for longitudinal data. Results: Among 57 patients, the mean age was 57 (SD 10.9) years, 24 (42\%) were female, 43 (75\%) had advanced gastrointestinal cancer, 14 (25\%) had advanced lung cancer, and 25 (44\%) were hospitalized or died during follow-up. A 1-point weekly increase (on a 32-point scale) in aggregate PRO score was associated with 247 fewer mean daily steps (95\% CI --277 to --213; P<.001). PROs most strongly associated with step count decline were patient-reported activity (daily step change --892), nausea score (--677), and constipation score (524). A 1-point weekly increase in aggregate PRO score was associated with 20\% greater odds of hospitalization or death (adjusted odds ratio [aOR] 1.2, 95\% CI 1.1-1.4; P=.01). PROs most strongly associated with hospitalization or death were pain (aOR 3.2, 95\% CI 1.6-6.5; P<.001), decreased activity (aOR 3.2, 95\% CI 1.4-7.1; P=.01), dyspnea (aOR 2.6, 95\% CI 1.2-5.5; P=.02), and sadness (aOR 2.1, 95\% CI 1.1-4.3; P=.03). A decrease in 1000 steps was associated with 16\% greater odds of hospitalization or death (aOR 1.2, 95\% CI 1.0-1.3; P=.03). Compared with baseline, mean daily step count decreased 7\% (n=274 steps), 9\% (n=351 steps), and 16\% (n=667 steps) in the 3, 2, and 1 weeks before hospitalization or death, respectively. Conclusions: In this secondary analysis of a randomized trial among patients with advanced cancer, higher symptom burden and decreased step count were independently associated with and predictably worsened close to hospitalization or death. Future interventions should leverage longitudinal PRO and step count data to target interventions toward patients at risk for poor outcomes. Trial Registration: ClinicalTrials.gov NCT04616768; https://clinicaltrials.gov/study/NCT04616768 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-054675 ",
doi="10.2196/51059",
url="https://www.jmir.org/2024/1/e51059",
url="http://www.ncbi.nlm.nih.gov/pubmed/38758583"
}


@Article{info:doi/10.2196/55917,
author="Trojan, Andreas
and K{\"u}hne, Christian
and Kiessling, Michael
and Schumacher, Johannes
and Dr{\"o}se, Stefan
and Singer, Christian
and Jackisch, Christian
and Thomssen, Christoph
and Kullak-Ublick, A. Gerd",
title="Impact of Electronic Patient-Reported Outcomes on Unplanned Consultations and Hospitalizations in Patients With Cancer Undergoing Systemic Therapy: Results of a Patient-Reported Outcome Study Compared With Matched Retrospective Data",
journal="JMIR Form Res",
year="2024",
month="May",
day="6",
volume="8",
pages="e55917",
keywords="systemic cancer therapy",
keywords="electronic patient-reported outcome",
keywords="ePRO",
keywords="ePROs",
keywords="Consilium Care",
keywords="medidux",
keywords="unplanned consultation",
keywords="hospitalization",
keywords="hospitalizations",
keywords="hospitalized",
keywords="cancer",
keywords="oncology",
keywords="side effect",
keywords="side effects",
keywords="adverse",
keywords="chemotherapy",
keywords="patient reported outcome",
keywords="PRO",
keywords="PROs",
keywords="mobile health",
keywords="mHealth",
keywords="app",
keywords="apps",
keywords="application",
keywords="applications",
keywords="mobile phone",
abstract="Background: The evaluation of electronic patient-reported outcomes (ePROs) is increasingly being used in clinical studies of patients with cancer and enables structured and standardized data collection in patients' everyday lives. So far, few studies or analyses have focused on the medical benefit of ePROs for patients. Objective: The current exploratory analysis aimed to obtain an initial indication of whether the use of the Consilium Care app (recently renamed medidux; mobile Health AG) for structured and regular self-assessment of side effects by ePROs had a recognizable effect on incidences of unplanned consultations and hospitalizations of patients with cancer compared to a control group in a real-world care setting without app use. To analyze this, the incidences of unplanned consultations and hospitalizations of patients with cancer using the Consilium Care app that were recorded by the treating physicians as part of the patient reported outcome (PRO) study were compared retrospectively to corresponding data from a comparable population of patients with cancer collected at 2 Swiss oncology centers during standard-of-care treatment. Methods: Patients with cancer in the PRO study (178 included in this analysis) receiving systemic therapy in a neoadjuvant or noncurative setting performed a self-assessment of side effects via the Consilium Care app over an observational period of 90 days. In this period, unplanned (emergency) consultations and hospitalizations were documented by the participating physicians. The incidence of these events was compared with retrospective data obtained from 2 Swiss tumor centers for a matched cohort of patients with cancer. Results: Both patient groups were comparable in terms of age and gender ratio, as well as the distribution of cancer entities and Joint Committee on Cancer stages. In total, 139 patients from each group were treated with chemotherapy and 39 with other therapies. Looking at all patients, no significant difference in events per patient was found between the Consilium group and the control group (odds ratio 0.742, 90\% CI 0.455-1.206). However, a multivariate regression model revealed that the interaction term between the Consilium group and the factor ``chemotherapy'' was significant at the 5\% level (P=.048). This motivated a corresponding subgroup analysis that indicated a relevant reduction of the risk for the intervention group in the subgroup of patients who underwent chemotherapy. The corresponding odds ratio of 0.53, 90\% CI 0.288-0.957 is equivalent to a halving of the risk for patients in the Consilium group and suggests a clinically relevant effect that is significant at a 2-sided 10\% level (P=.08, Fisher exact test). Conclusions: A comparison of unplanned consultations and hospitalizations from the PRO study with retrospective data from a comparable cohort of patients with cancer suggests a positive effect of regular app-based ePROs for patients receiving chemotherapy. These data are to be verified in the ongoing randomized PRO2 study (registered on ClinicalTrials.gov; NCT05425550). Trial Registration: ClinicalTrials.gov NCT03578731; https://www.clinicaltrials.gov/ct2/show/NCT03578731 International Registered Report Identifier (IRRID): RR2-10.2196/29271 ",
doi="10.2196/55917",
url="https://formative.jmir.org/2024/1/e55917",
url="http://www.ncbi.nlm.nih.gov/pubmed/38710048"
}


@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/10.2196/55662,
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/10.2196/47359,
author="Shinn, H. Eileen
and Garden, S. Adam
and Peterson, K. Susan
and Leupi, J. Dylan
and Chen, Minxing
and Blau, Rachel
and Becerra, Laura
and Rafeedi, Tarek
and Ramirez, Julian
and Rodriquez, Daniel
and VanFossen, Finley
and Zehner, Sydney
and Mercier, P. Patrick
and Wang, Joseph
and Hutcheson, Kate
and Hanna, Ehab
and Lipomi, J. Darren",
title="Iterative Patient Testing of a Stimuli-Responsive Swallowing Activity Sensor to Promote Extended User Engagement During the First Year After Radiation: Multiphase Remote and In-Person Observational Cohort Study",
journal="JMIR Cancer",
year="2024",
month="Feb",
day="28",
volume="10",
pages="e47359",
keywords="user-centered design",
keywords="patients with head and neck cancer",
keywords="dysphagia throat sensor",
abstract="Background: Frequent sensor-assisted monitoring of changes in swallowing function may help improve detection of radiation-associated dysphagia before it becomes permanent. While our group has prototyped an epidermal strain/surface electromyography sensor that can detect minute changes in swallowing muscle movement, it is unknown whether patients with head and neck cancer would be willing to wear such a device at home after radiation for several months. Objective: We iteratively assessed patients' design preferences and perceived barriers to long-term use of the prototype sensor. Methods: In study 1 (questionnaire only), survivors of pharyngeal cancer who were 3-5 years post treatment and part of a larger prospective study were asked their design preferences for a hypothetical throat sensor and rated their willingness to use the sensor at home during the first year after radiation. In studies 2 and 3 (iterative user testing), patients with and survivors of head and neck cancer attending visits at MD Anderson's Head and Neck Cancer Center were recruited for two rounds of on-throat testing with prototype sensors while completing a series of swallowing tasks. Afterward, participants were asked about their willingness to use the sensor during the first year post radiation. In study 2, patients also rated the sensor's ease of use and comfort, whereas in study 3, preferences were elicited regarding haptic feedback. Results: The majority of respondents in study 1 (116/138, 84\%) were willing to wear the sensor 9 months after radiation, and participant willingness rates were similar in studies 2 (10/14, 71.4\%) and 3 (12/14, 85.7\%). The most prevalent reasons for participants' unwillingness to wear the sensor were 9 months being excessive, unwanted increase in responsibility, and feeling self-conscious. Across all three studies, the sensor's ability to detect developing dysphagia increased willingness the most compared to its appearance and ability to increase adherence to preventive speech pathology exercises. Direct haptic signaling was also rated highly, especially to indicate correct sensor placement and swallowing exercise performance. Conclusions: Patients and survivors were receptive to the idea of wearing a personalized risk sensor for an extended period during the first year after radiation, although this may have been limited to well-educated non-Hispanic participants. A significant minority of patients expressed concern with various aspects of the sensor's burden and its appearance. Trial Registration: ClinicalTrials.gov NCT03010150; https://clinicaltrials.gov/study/NCT03010150 ",
doi="10.2196/47359",
url="https://cancer.jmir.org/2024/1/e47359",
url="http://www.ncbi.nlm.nih.gov/pubmed/38416544"
}


@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/10.2196/46001,
author="Chen, Leeann
and Bartel, Christianna
and Cai, Xinlu
and Cheng, Yanghuidi
and Perer, Adam
and McClaine, Sean
and Kairis, Elizabeth
and Durica, Krina
and Huang, Weiyu
and Low, A. Carissa",
title="Patient and Provider Perspectives on Symptom Monitoring During Outpatient Chemotherapy: Interview Study",
journal="JMIR Form Res",
year="2023",
month="Apr",
day="17",
volume="7",
pages="e46001",
keywords="symptom management",
keywords="remote patient monitoring",
keywords="doctor-patient communication",
keywords="mobile technology",
keywords="cancer",
keywords="ambulatory",
keywords="chemotherapy",
keywords="oncology",
keywords="remote monitoring",
keywords="outpatient",
keywords="mobile phone",
abstract="Background: Fluctuating symptoms and side effects are common during outpatient cancer treatment, and approaches to monitoring symptoms vary widely across providers, patients, and clinical settings. To design a remote symptom monitoring system that patients and providers find to be useful, it may be helpful to understand current clinical approaches to monitoring and managing chemotherapy-related symptoms among patients and providers and assess how more frequent and systematic assessment and sharing of data could improve patient and provider experiences. Objective: The goals of this study were to learn about patient and provider perspectives on monitoring symptoms during chemotherapy, understand barriers and challenges to effective symptom monitoring at one institution, and explore the potential value of remote symptom monitoring between provider visits. Methods: A total of 15 patients who were currently undergoing or had recently completed chemotherapy and 7 oncology providers participated in semistructured interviews. Interviews were transcribed and coded using an iterative thematic analysis approach. The study was conducted at a National Cancer Institute--Designated Comprehensive Cancer Center. Results: Four main themes were discussed by patients and providers: (1) asynchronous nature of current methods for tracking and managing symptoms, (2) variability in reported symptoms due to patient factors, (3) limitations of existing communication channels, and (4) potential value of real-time remote symptom monitoring during chemotherapy. Current asynchronous methods and existing communication channels resulted in a disconnect between when symptoms are most severe and when conversations about symptoms happen, a situation further complicated by memory impairments during chemotherapy. Patients and providers both highlighted improvements in patient-provider communication as a potential benefit of remote real-time symptom monitoring. Providers also emphasized the value of temporal data regarding when symptoms first emerge and how they progress over time, as well as the potential value of concurrent activity or other data about daily activities and functioning. Patients noted that symptom monitoring could result in better preparation for subsequent treatment cycles. Conclusions: Both patients and providers highlighted significant challenges of asynchronous, patient-initiated, phone-dependent symptom monitoring and management. Oncology patients and providers reported that more routine remote monitoring of symptoms between visits could improve patient-provider communication, prepare patients for subsequent chemotherapy cycles, and facilitate provider insight and clinical decision-making with regard to symptom management. ",
doi="10.2196/46001",
url="https://formative.jmir.org/2023/1/e46001",
url="http://www.ncbi.nlm.nih.gov/pubmed/37067857"
}


@Article{info:doi/10.2196/45244,
author="Nilsen, Skogstad Tormod
and S{\ae}ter, Mali
and Sarvari, Imre Sebastian
and Reinertsen, Valborg Kristin
and Johansen, Hassing Sara
and Edvardsen, Rustad Elisabeth
and Hall{\'e}n, Jostein
and Edvardsen, Elisabeth
and Grydeland, May
and Kiserud, Essholt Cecilie
and Lie, Cathrine Hanne
and Solberg, Andr{\'e} Paul
and Wisl{\o}ff, Torbj{\o}rn
and Sharples, Philip Adam
and Raastad, Truls
and Haugaa, Hermann Kristina
and Thorsen, Lene",
title="Effects of Aerobic Exercise on Cardiorespiratory Fitness, Cardiovascular Risk Factors, and Patient-Reported Outcomes in Long-Term Breast Cancer Survivors: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Mar",
day="15",
volume="12",
pages="e45244",
keywords="breast cancer",
keywords="cardiooncology",
keywords="cardiorespiratory fitness",
keywords="exercise medicine",
abstract="Background: Anthracycline-based chemotherapy has been mainstay of adjuvant breast cancer therapy for decades. Although effective, anthracyclines place long-term breast cancer survivors at risk of late effects, such as reduced cardiorespiratory fitness and increased risk of cardiovascular disease. Previous research has shown beneficial effects of exercise training on cardiorespiratory fitness, but the effects of exercise on limiting factors for cardiorespiratory fitness, cardiovascular risk factors, and patient-reported outcomes in long-term survivors are less clear. Whether previous exposure to breast cancer therapy modulates the effects of exercise is also unknown. Objective: The primary aim of the CAUSE (Cardiovascular Survivors Exercise) trial is to examine the effect of aerobic exercise on cardiorespiratory fitness in anthracycline-treated long-term breast cancer survivors. Secondary aims are to examine effects of exercise training on limiting factors for cardiorespiratory fitness, cardiovascular risk factors, and patient-reported outcomes, and to compare baseline values and effects of exercise training between similar-aged women with and those without prior breast cancer. A third aim is to examine the 24-month postintervention effects of aerobic exercise on primary and secondary outcomes. Methods: The CAUSE trial is a 2-armed randomized controlled trial, where 140 long-term breast cancer survivors, 8-12 years post diagnosis, are assigned to a 5-month nonlinear aerobic exercise program with 3 weekly sessions or to standard care. Seventy similar-aged women with no history of cancer will undergo the same exercise program. Cardiorespiratory fitness measured as peak oxygen consumption (VO2peak), limiting factors for VO2peak (eg, cardiac function, pulmonary function, hemoglobin mass, blood volume, and skeletal muscle characteristics), cardiovascular risk factors (eg, hypertension, diabetes, dyslipidemia, obesity, physical activity level, and smoking status), and patient-reported outcomes (eg, body image, fatigue, mental health, and health-related quality of life) will be assessed at baseline, post intervention, and 24 months post intervention. Results: A total of 209 patients were included from October 2020 to August 2022, and postintervention assessments were completed in January 2023. The 24-month follow-up will be completed in February 2025. Conclusions: The findings from the CAUSE trial will provide novel scientific understanding of the potential benefits of exercise training in long-term breast cancer survivors. Trial Registration: ClinicalTrials.gov NCT04307407; https://clinicaltrials.gov/ct2/show/NCT04307407 International Registered Report Identifier (IRRID): DERR1-10.2196/45244 ",
doi="10.2196/45244",
url="https://www.researchprotocols.org/2023/1/e45244",
url="http://www.ncbi.nlm.nih.gov/pubmed/36920460"
}


@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/10.2196/40811,
author="Vikmoen, Olav
and Wiestad, Helge Tor
and Thormodsen, Inger
and Nordin, Karin
and Berntsen, Sveinung
and Demmelmaier, Ingrid
and Strandberg, Emelie
and Raastad, Truls",
title="Effects of High and Low-To-Moderate Intensity Exercise During (Neo-) Adjuvant Chemotherapy on Muscle Cells, Cardiorespiratory Fitness, and Muscle Function in Women With Breast Cancer: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2022",
month="Nov",
day="11",
volume="11",
number="11",
pages="e40811",
keywords="resistance training",
keywords="endurance training",
keywords="muscle strength",
keywords="muscle endurance",
keywords="anthracyclines",
keywords="taxanes",
abstract="Background: (Neo-)adjuvant chemotherapy for breast cancer is effective but has deleterious side effects on muscle tissue, resulting in reduced skeletal muscle mass, muscle function, and cardiorespiratory fitness. Various exercise regimens during cancer treatment have been shown to counteract some of these side effects. However, no study has compared the effect of high-intensity training versus low-to-moderate intensity training on muscle tissue cellular outcomes and physical function in patients with breast cancer during chemotherapy. Objective: The aim of this substudy within the Physical Training in Cancer (Phys-Can) consortium is to evaluate and compare the effects of high and low-to-moderate intensity exercise on muscle cellular outcomes, muscle function, and cardiorespiratory fitness in women with breast cancer undergoing (neo-)adjuvant chemotherapy. We further aim to investigate if the effects of chemotherapy including taxanes on muscles will be different from those of taxane-free chemotherapy. Methods: Eighty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to a combination of strength and endurance training, either at high intensity or at low-to-moderate intensity. Testing of muscle function and cardiorespiratory fitness and collection of muscle biopsies from the vastus lateralis muscle will be performed before the first cycle of chemotherapy (or after 1 week, when not possible) (T0), halfway through chemotherapy (T1), and after completion of chemotherapy (T2). It is estimated that approximately 50\% of the participants will be willing to undergo muscle biopsies. To separate the effect of the treatment itself, a usual care group with no supervised training will also be included, and in this group, testing and collection of muscle biopsies will be performed at T0 and T2 only. Results: This study is funded by Active Against Cancer (Aktiv mot kreft) (May 2013) and the Norwegian Cancer Society (December 2018). Inclusion started in December 2016 and the last participant is expected to be recruited in December 2022. As of June 2022, we enrolled 38 (19 with biopsies) participants to the high-intensity training group, 36 (19 with biopsies) participants to the low-to-moderate intensity training group, and 17 (16 with biopsies) participants to the usual care group. Data analyses will start in fall 2022. The first results are expected to be published in spring 2024. Conclusions: This study will generate new knowledge about the effects of different training intensities for women with breast cancer during chemotherapy treatment. It will give further insight into how chemotherapy affects the muscle tissue and how physical training at different intensities may counteract the treatment side effects in muscles. The results of this study will inform the development and refinement of exercise programs that are effective and compatible with the multidisciplinary management of breast cancer. Trial Registration: ClinicalTrials.gov NCT05218876; https://tinyurl.com/ysaj9dhm International Registered Report Identifier (IRRID): DERR1-10.2196/40811 ",
doi="10.2196/40811",
url="https://www.researchprotocols.org/2022/11/e40811",
url="http://www.ncbi.nlm.nih.gov/pubmed/36367769"
}


@Article{info:doi/10.2196/36654,
author="Mangsbacka, Maria
and Gustavell, Tina",
title="Nurses' Experiences Using an Interactive System to Assess and Manage Treatment-Related Symptoms of Patients With Pancreatic Cancer: Interview Study",
journal="JMIR Nursing",
year="2022",
month="May",
day="16",
volume="5",
number="1",
pages="e36654",
keywords="app",
keywords="health care professionals",
keywords="mobile health",
keywords="mHealth",
keywords="nurses",
keywords="pancreatic cancer",
keywords="person-centered care",
keywords="symptom-management",
keywords="qualitative interview",
keywords="nursing",
keywords="interview",
abstract="Background: Treatment for pancreatic cancer entails symptom distress and a high burden of self-care. Patient-reported outcomes, collected with the support of mobile health (mHealth), have shown positive effects on symptom management, patient satisfaction, and quality of life for patients with cancer. For mHealth tools to become an integral part of clinical routine, experiences from health care professionals are needed. Objective: The aim of this paper is to describe nurses' experiences of integrating an interactive system (Interaktor) for symptom assessment and management into daily practice, when caring for patients following pancreaticoduodenectomy and during chemotherapy treatment due to pancreatic cancer. Methods: Patients reported symptoms via the Interaktor app daily for 6 months. In the event of alarming symptoms, an alert was triggered to the patient's nurse who then called the patient to offer advice and support. All nurses (n=8) who assessed patients were interviewed either individually or in a group. Transcribed interviews were analyzed using qualitative thematic analysis. Results: mHealth can facilitate person-centered care by offering nurses a way to gain knowledge about patients and to build relationships. Further, obstacles to implementation could be seen due to a lack of structural prerequisites and uncertainty about multiple ways to interact with patients. Conclusions: The Interaktor system can provide person-centered care. However, to implement mHealth tools as a clinical routine, focus needs to be placed on creating the necessary organizational conditions. ",
doi="10.2196/36654",
url="https://nursing.jmir.org/2022/1/e36654",
url="http://www.ncbi.nlm.nih.gov/pubmed/35576577"
}


@Article{info:doi/10.2196/37709,
author="Keats, R. Melanie
and Grandy, A. Scott
and Blanchard, Christopher
and Fowles, R. Jonathon
and Neyedli, F. Heather
and Weeks, C. Adrienne
and MacNeil, V. Mary",
title="The Impact of Resistance Exercise on Muscle Mass in Glioblastoma in Survivors (RESIST): Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2022",
month="May",
day="4",
volume="11",
number="5",
pages="e37709",
keywords="glioblastoma",
keywords="myopathy",
keywords="resistance exercise",
keywords="functional fitness",
keywords="quality of life",
keywords="intervention",
keywords="randomized controlled trial",
abstract="Background: Glioblastoma is the most common primary brain malignancy in adults, accounting for approximately 48\% of all brain tumors. Standard treatment includes radiation and temozolomide chemotherapy. Glioblastomas are highly vascular and can cause vasogenic brain edema and mass effect, which can worsen the neurologic symptoms associated with the disease. The steroid dexamethasone (DEX) is the treatment of choice to reduce vasogenic edema and intracranial pressure associated with glioblastoma. However high-dose DEX or long-term use can result in muscle myopathy in 10\%-60\% of glioblastoma patients, significantly reducing functional fitness and quality of life (QOL). There is a wealth of evidence to support the use of exercise as an adjuvant therapy to improve functional ability as well as help manage treatment-related symptoms. Specifically, resistance training has been shown to increase muscle mass, strength, and functional fitness in aging adults and several cancer populations. Although studies are limited, research has shown that exercise is safe and feasible in glioblastoma populations. However, it is not clear whether resistance training can be successfully used in glioblastoma to prevent or mitigate steroid-induced muscle myopathy and associated loss of function. Objective: The primary purpose of this study is to establish whether an individualized circuit-based program will reduce steroid-induced muscle myopathy, as indicated by maintained or improved functional fitness for patients on active treatment and receiving steroids. Methods: This is a 2-armed, randomized controlled trial with repeated measures. We will recruit 38 adult (?18 years) patients diagnosed with either primary or secondary glioblastoma who are scheduled to receive standard radiation and concurrent and adjuvant temozolomide chemotherapy postsurgical debulking and received any dose of DEX through the neurooncology clinic and the Nova Scotia Health Cancer Center. Patients will be randomly allocated to a standard of care waitlist control group or standard of care + circuit-based resistance training exercise group. The exercise group will receive a 12-week individualized, group and home-based exercise program. The control group will be advised to maintain an active lifestyle. The primary outcome, muscle myopathy (functional fitness), will be assessed using the Short Physical Performance Battery and hand grip strength. Secondary outcome measures will include body composition, cardiorespiratory fitness, physical activity, QOL, fatigue, and cognitive function. All measures will be assessed pre- and postintervention. Participant accrual, exercise adherence, and safety will be assessed throughout the study. Results: This study has been funded by the Canadian Cancer Society Atlantic Cancer Research Grant and the J.D. Irving Limited--Excellence in Cancer Research Fund (grant number 707182). The protocol was approved by the Nova Scotia Health and Acadia University's Research Ethics Boards. Enrollment is anticipated to begin in March 2022. Conclusions: This study will inform how individualized circuit-based resistance training may improve functional independence and overall QOL of glioblastoma patients. Trial Registration: ClinicalTrails.gov NCT05116137; https://www.clinicaltrials.gov/ct2/show/NCT05116137 International Registered Report Identifier (IRRID): DERR1-10.2196/37709 ",
doi="10.2196/37709",
url="https://www.researchprotocols.org/2022/5/e37709",
url="http://www.ncbi.nlm.nih.gov/pubmed/35507403"
}


@Article{info:doi/10.2196/29292,
author="Kudel, Ian
and Perry, Toni",
title="Communicating Treatment-Related Symptoms Using Passively Collected Data and Satisfaction/Loyalty Ratings: Exploratory Study",
journal="JMIR Cancer",
year="2022",
month="Apr",
day="29",
volume="8",
number="2",
pages="e29292",
keywords="electronic patient-reported outcomes",
keywords="ePRO",
keywords="cancer",
keywords="symptoms",
keywords="health-related quality of life",
abstract="Background: Electronic patient-reported outcomes' real time communication of treatment-related symptoms is increasingly associated with better outcomes including longer survival and less health care resource use, but the primary method of collecting this information, static questionnaires, has not evolved. Objective: The aim of this paper is to describe the use of Noona's three methods of communicating treatment-related symptoms, which are as follows: (1) Noona symptom questionnaires (NSQ), which incorporate branching logic; (2) a diary; and (3) secure messaging, the last two of which have NSQ reporting functionality. It also aims to explore, using multivariable analyses, whether patients find value using these features. Methods: Noona users (N=1081) who have an active account for more than 30 days, who responded to the satisfaction/loyalty item, and who were undergoing active cancer treatment (systemic or radiotherapy) in the United States were included in this study. All study data were collected via software embedded within Noona code. This includes metadata, patient activities (measured in clicks), and responses to a satisfaction/loyalty question (``How likely are you to recommend Noona to another patient'') displayed on the Noona home page. Results: Noona users expressed a high degree of satisfaction/loyalty when asked to rate how likely they would recommend Noona to another patient. Multivariable analyses indicate small but significant effects for some of the analyses. Use of NSQs were significantly related to satisfaction/loyalty, users of NSQs had significantly higher satisfaction/loyalty than those who did not use any, and secure communication use was significantly higher for those who rated the app highly compared to those who did not. These relationships will likely be further explicated with the use of satisfaction/loyalty questions that focus specifically on feature use. Conclusions: Noona is well liked by respondents, and exploratory multivariable analyses demonstrate the potential for using passively and minimally invasive data to demonstrate value. ",
doi="10.2196/29292",
url="https://cancer.jmir.org/2022/2/e29292",
url="http://www.ncbi.nlm.nih.gov/pubmed/35175206"
}


@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/10.2196/29579,
author="Janssen, Anna
and Fletcher, Jennifer
and Keep, Melanie
and Ahmadpour, Naseem
and Rouf, Anika
and Marthick, Michael
and Booth, Rebecca",
title="Experiences of Patients Undergoing Chemotherapy With Virtual Reality: Mixed Methods Feasibility Study",
journal="JMIR Serious Games",
year="2022",
month="Feb",
day="21",
volume="10",
number="1",
pages="e29579",
keywords="eHealth",
keywords="digital health",
keywords="virtual reality",
keywords="cancer",
keywords="chemotherapy",
keywords="mixed methods research",
keywords="virtual health",
keywords="serious games",
keywords="treatment",
abstract="Background: Current research into virtual reality (VR) use during chemotherapy shows that it can be an effective distraction intervention. However, there is limited research in adult patients and to investigate how VR can be sustainably implemented in health care organizations. Objective: The aim of this study was to explore the feasibility and acceptability of using VR for adult patients undergoing chemotherapy, and to identify the factors that would enable the sustained use of VR during chemotherapy in health care organizations. Methods: Patients undergoing chemotherapy were recruited to participate in a VR intervention during chemotherapy infusion. Participants were observed during the session and completed a postintervention survey. Each participant was invited to participate in a semistructured interview about their experience. Results: A total of 18 patients participated in the study, 5 of whom participated in semistructured interviews. Findings indicated that the use of VR was acceptable for patients undergoing chemotherapy and the intervention was also feasible. Some participants felt that the VR was an effective distraction during chemotherapy infusion, although most still seemed to be aware of how long their treatment was taking. Although VR was acceptable and feasible to patients, interviews identified several barriers to sustained implementation, including access to a reliable app library and impact on staff workloads. Conclusions: VR was acceptable to patients with a diagnosis of cancer undergoing chemotherapy treatment. Patients found VR beneficial for breaking up the monotony of treatment, to provide an additional choice of activity in addition to other recreation, and in some instances as a distraction from the treatment itself. However, there are challenges to address if VR is to be implemented in practice for this patient group. ",
doi="10.2196/29579",
url="https://games.jmir.org/2022/1/e29579",
url="http://www.ncbi.nlm.nih.gov/pubmed/35188474"
}


@Article{info:doi/10.2196/33651,
author="Fyhr, AnnSofie
and Persson, Johanna
and Ek, {\AA}sa",
title="Usage and Usability of a National e-Library for Chemotherapy Regimens: Mixed Methods Study",
journal="JMIR Hum Factors",
year="2022",
month="Feb",
day="17",
volume="9",
number="1",
pages="e33651",
keywords="chemotherapy regimens",
keywords="user evaluation",
keywords="standardization",
keywords="patient safety",
keywords="chemotherapy",
keywords="safety",
keywords="usability",
keywords="e-library",
keywords="medication errors",
abstract="Background: Accurate information about chemotherapy drugs and regimens is needed to reduce chemotherapy errors. A national e-library, as a common knowledge source with standardized chemotherapy nomenclature and content, was developed. Since the information in the library is both complex and extensive, it is central that the users can use the resource as intended. Objective: The aim of this study was to evaluate the usage and usability of an extensive e-library for chemotherapy regimens developed to reduce medication errors, support the health care staff in their work, and increase patient safety. Methods: To obtain a comprehensive evaluation, a mixed methods study was performed for a broad view of the usage, including a compilation of subjective views of the users (web survey, spontaneous user feedback, and qualitative interviews), analysis of statistics from the website, and an expert evaluation of the usability of the webpage. Results: Statistics from the website show an average of just over 2500 visits and 870 unique visitors per month. Most visits took place Mondays to Fridays, but there were 5-10 visits per day on weekends. The web survey, with 292 answers, shows that the visitors were mainly physicians and nurses. Almost 80\% (224/292) of respondents searched for regimens and 90\% (264/292) found what they were looking for and were satisfied with their visit. The expert evaluation shows that the e-library follows many existing design principles, thus providing some useful improvement suggestions. A total of 86 emails were received in 2020 with user feedback, most of which were from nurses. The main part (78\%, 67/86) contained a question, and the rest had discovered errors mainly in some regimen. The interviews reveal that most hospitals use a computerized physician order entry system, and they use the e-library in various ways, import XML files, transfer information, or use it as a reference. One hospital without a system uses the administration schedules from the library. Conclusions: The user evaluation indicates that the e-library is used in the intended manner and that the users can interact without problems. Users have different needs depending on their profession and their workplace, and these can be supported. The combination of methods applied ensures that the design and content comply with the users' needs and serves as feedback for continuous design and learning. With a broad national usage, the e-library can become a source for organizational and national learning and a source for continuous improvement of cancer care in Sweden. ",
doi="10.2196/33651",
url="https://humanfactors.jmir.org/2022/1/e33651",
url="http://www.ncbi.nlm.nih.gov/pubmed/35175199"
}


@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/10.2196/27024,
author="Mosa, Mohammad Abu Saleh
and Rana, Zaman Md Kamruz
and Islam, Humayera
and Hossain, Mosharraf A. K. M.
and Yoo, Illhoi",
title="A Smartphone-Based Decision Support Tool for Predicting Patients at Risk of Chemotherapy-Induced Nausea and Vomiting: Retrospective Study on App Development Using Decision Tree Induction",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Dec",
day="2",
volume="9",
number="12",
pages="e27024",
keywords="chemotherapy",
keywords="CINV risk factors",
keywords="data mining",
keywords="prediction",
keywords="decision trees",
keywords="clinical decision support",
keywords="smartphone app",
abstract="Background: Chemotherapy-induced nausea and vomiting (CINV) are the two most frightful and unpleasant side effects of chemotherapy. CINV is accountable for poor treatment outcomes, treatment failure, or even death. It can affect patients' overall quality of life, leading to many social, economic, and clinical consequences. Objective: This study compared the performances of different data mining models for predicting the risk of CINV among the patients and developed a smartphone app for clinical decision support to recommend the risk of CINV at the point of care. Methods: Data were collected by retrospective record review from the electronic medical records used at the University of Missouri Ellis Fischel Cancer Center. Patients who received chemotherapy and standard antiemetics at the oncology outpatient service from June 1, 2010, to July 31, 2012, were included in the study. There were six independent data sets of patients based on emetogenicity (low, moderate, and high) and two phases of CINV (acute and delayed). A total of 14 risk factors of CINV were chosen for data mining. For our study, we used five popular data mining algorithms: (1) naive Bayes algorithm, (2) logistic regression classifier, (3) neural network, (4) support vector machine (using sequential minimal optimization), and (5) decision tree. Performance measures, such as accuracy, sensitivity, and specificity with 10-fold cross-validation, were used for model comparisons. A smartphone app called CINV Risk Prediction Application was developed using the ResearchKit in iOS utilizing the decision tree algorithm, which conforms to the criteria of explainable, usable, and actionable artificial intelligence. The app was created using both the bulk questionnaire approach and the adaptive approach. Results: The decision tree performed well in both phases of high emetogenic chemotherapies, with a significant margin compared to the other algorithms. The accuracy measure for the six patient groups ranged from 79.3\% to 94.8\%. The app was developed using the results from the decision tree because of its consistent performance and simple, explainable nature. The bulk questionnaire approach asks 14 questions in the smartphone app, while the adaptive approach can determine questions based on the previous questions' answers. The adaptive approach saves time and can be beneficial when used at the point of care. Conclusions: This study solved a real clinical problem, and the solution can be used for personalized and precise evidence-based CINV management, leading to a better life quality for patients and reduced health care costs. ",
doi="10.2196/27024",
url="https://mhealth.jmir.org/2021/12/e27024",
url="http://www.ncbi.nlm.nih.gov/pubmed/34860677"
}


@Article{info:doi/10.2196/22931,
author="Ghods, Alireza
and Shahrokni, Armin
and Ghasemzadeh, Hassan
and Cook, Diane",
title="Remote Monitoring of the Performance Status and Burden of Symptoms of Patients With Gastrointestinal Cancer Via a Consumer-Based Activity Tracker: Quantitative Cohort Study",
journal="JMIR Cancer",
year="2021",
month="Nov",
day="26",
volume="7",
number="4",
pages="e22931",
keywords="step count",
keywords="performance status",
keywords="symptom",
keywords="wearable",
keywords="activity tracker",
keywords="gastrointestinal cancer",
keywords="monitoring",
keywords="cancer",
keywords="gastrointestinal",
keywords="burden",
abstract="Background: The number of older patients with gastrointestinal cancer is increasing due to an aging global population. Minimizing reliance on an in-clinic patient performance status test to determine a patient's prognosis and course of treatment can improve resource utilization. Further, current performance status measurements cannot capture patients' constant changes. These measurements also rely on self-reports, which are subjective and subject to bias. Real-time monitoring of patients' activities may allow for a more accurate assessment of patients' performance status while minimizing resource utilization. Objective: This study investigates the validity of consumer-based activity trackers for monitoring the performance status of patients with gastrointestinal cancer. Methods: A total of 27 consenting patients (63\% male, median age 58 years) wore a consumer-based activity tracker 7 days before chemotherapy and 14 days after receiving their first treatment. The provider assessed patients using the Eastern Cooperative Oncology Group Performance Status (ECOG-PS) scale and Memorial Symptom Assessment Scale-Short Form (MSAS-SF) before and after chemotherapy visits. The statistical correlations between ECOG-PS and MSAS-SF scores and patients' daily step counts were assessed. Results: The daily step counts yielded the highest correlation with the patients' ECOG-PS scores after chemotherapy (P<.001). The patients with higher ECOG-PS scores experienced a higher fluctuation in their step counts. The patients who walked more prechemotherapy (mean 6071 steps per day) and postchemotherapy (mean 5930 steps per day) had a lower MSAS-SF score (lower burden of symptoms) compared to patients who walked less prechemotherapy (mean 5205 steps per day) and postchemotherapy (mean 4437 steps per day). Conclusions: This study demonstrates the feasibility of using inexpensive, consumer-based activity trackers for the remote monitoring of performance status in the gastrointestinal cancer population. The findings need to be validated in a larger population for generalizability. ",
doi="10.2196/22931",
url="https://cancer.jmir.org/2021/4/e22931",
url="http://www.ncbi.nlm.nih.gov/pubmed/34842527"
}


@Article{info:doi/10.2196/25648,
author="Murat-Ringot, Audrey
and Souquet, Jean Pierre
and Subtil, Fabien
and Boutitie, Florent
and Preau, Marie
and Piriou, Vincent",
title="The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial",
journal="JMIR Cancer",
year="2021",
month="Nov",
day="5",
volume="7",
number="4",
pages="e25648",
keywords="cancer",
keywords="randomized controlled trial",
keywords="foot reflexology",
keywords="nausea and vomiting",
keywords="chemotherapy",
keywords="complementary and alternative medicine",
abstract="Background: Cancer is a chronic disease with an incidence of 24.5 million and 9.6 million deaths worldwide in 2017. Lung and colorectal cancer are the most common cancers for both sexes and, according to national and international recommendations, platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) may persist. Moreover, cancer patients are increasingly interested in alternative and complementary medicines and have expressed the desire that nonpharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology significantly decreases the severity of CINV in patients with breast cancer. Objective: The primary aim of this study was to assess the benefits of foot reflexology as a complement therapy to conventional treatments regarding the severity of acute CINV in patients with digestive or lung cancer. The secondary objectives assessed were the frequency and severity of delayed CINV, quality of life, anxiety, and self-esteem. Methods: This study was conducted between April 2018 and April 2020 in the Hospices Civils de Lyon, France. This was an open-label randomized controlled trial. Participants were randomized into two groups: the intervention group (ie, conventional care with foot reflexology; n=40) and the control group (ie, conventional care without foot reflexology; n=40). Foot reflexology sessions (30 minutes each) were performed on outpatients or inpatients. Eligible participants were patients with lung or digestive cancer with an indication for platinum-based chemotherapy. Results: The severity of acute nausea and vomiting was assessed with a visual analog scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for the control group (7/34, 21\%; P=.001). Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39). Regarding quality of life and anxiety, there was no significant difference between the intervention group and the control group (P=.32 and P=.53, respectively). Conclusions: This study's results indicate that foot reflexology provides significantly better management of acute nausea severity and decreased consumption of antiemetic drugs in patients with lung or digestive cancer. In order to fulfill patients' desires to use nonpharmacological treatments and complementary and alternative medicines in hospitals, foot reflexology could be provided as a complementary intervention to conventional antiemetic drugs. Foot reflexology did not result in adverse effects. To assess the benefits of foot reflexology in routine practice, a larger study with several health care centers would be needed with a cluster randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT03508180; https://clinicaltrials.gov/ct2/show/NCT03508180 International Registered Report Identifier (IRRID): RR2-10.2196/17232 ",
doi="10.2196/25648",
url="https://cancer.jmir.org/2021/4/e25648",
url="http://www.ncbi.nlm.nih.gov/pubmed/34738909"
}


@Article{info:doi/10.2196/32789,
author="Psihogios, M. Alexandra
and Rabbi, Mashfiqui
and Ahmed, Annisa
and McKelvey, R. Elise
and Li, Yimei
and Laurenceau, Jean-Philippe
and Hunger, P. Stephen
and Fleisher, Linda
and Pai, LH Ahna
and Schwartz, A. Lisa
and Murphy, A. Susan
and Barakat, P. Lamia",
title="Understanding Adolescent and Young Adult 6-Mercaptopurine Adherence and mHealth Engagement During Cancer Treatment: Protocol for Ecological Momentary Assessment",
journal="JMIR Res Protoc",
year="2021",
month="Oct",
day="22",
volume="10",
number="10",
pages="e32789",
keywords="mHealth",
keywords="ecological momentary assessment",
keywords="adolescents",
keywords="young adults",
keywords="oncology",
keywords="cancer",
keywords="self-management",
keywords="mobile phone",
abstract="Background: Adolescents and young adults (AYAs) with cancer demonstrate suboptimal oral chemotherapy adherence, increasing their risk of cancer relapse. It is unclear how everyday time-varying contextual factors (eg, mood) affect their adherence, stalling the development of personalized mobile health (mHealth) interventions. Poor engagement is also a challenge across mHealth trials; an effective adherence intervention must be engaging to promote uptake. Objective: This protocol aims to determine the temporal associations between daily contextual factors and 6-mercaptopurine (6-MP) adherence and explore the proximal impact of various engagement strategies on ecological momentary assessment survey completion. Methods: At the Children's Hospital of Philadelphia, AYAs with acute lymphoblastic leukemia or lymphoma who are prescribed prolonged maintenance chemotherapy that includes daily oral 6-MP are eligible, along with their matched caregivers. Participants will use an ecological momentary assessment app called ADAPTS (Adherence Assessments and Personalized Timely Support)---a version of an open-source app that was modified for AYAs with cancer through a user-centered process---and complete surveys in bursts over 6 months. Theory-informed engagement strategies will be microrandomized to estimate the causal effects on proximal survey completion. Results: With funding from the National Cancer Institute and institutional review board approval, of the proposed 30 AYA-caregiver dyads, 60\% (18/30) have been enrolled; of the 18 enrolled, 15 (83\%) have completed the study so far. Conclusions: This protocol represents an important first step toward prescreening tailoring variables and engagement components for a just-in-time adaptive intervention designed to promote both 6-MP adherence and mHealth engagement. International Registered Report Identifier (IRRID): DERR1-10.2196/32789 ",
doi="10.2196/32789",
url="https://www.researchprotocols.org/2021/10/e32789",
url="http://www.ncbi.nlm.nih.gov/pubmed/34677129"
}


@Article{info:doi/10.2196/28524,
author="Hauth, Franziska
and Gehler, Barbara
and Nie{\ss}, Michael Andreas
and Fischer, Katharina
and Toepell, Andreas
and Heinrich, Vanessa
and Roesel, Inka
and Peter, Andreas
and Renovanz, Mirjam
and Hartkopf, Andreas
and Stengel, Andreas
and Zips, Daniel
and Gani, Cihan",
title="An Activity Tracker--Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials)",
journal="JMIR Res Protoc",
year="2021",
month="Sep",
day="22",
volume="10",
number="9",
pages="e28524",
keywords="cancer",
keywords="fatigue",
keywords="physical activity",
keywords="quality of life",
keywords="activity tracker",
keywords="exercise program",
keywords="radiotherapy",
keywords="digital health",
abstract="Background: The positive impact that physical activity has on patients with cancer has been shown in several studies over recent years. However, supervised physical activity programs have several limitations, including costs and availability. Therefore, our study proposes a novel approach for the implementation of a patient-executed, activity tracker--guided exercise program to bridge this gap. Objective: Our trial aims to investigate the impact that an activity tracker--guided, patient-executed exercise program for patients undergoing radiotherapy has on cancer-related fatigue, health-related quality of life, and preoperative health status. Methods: Patients receiving postoperative radiotherapy for breast cancer (OnkoFit I trial) or neoadjuvant, definitive, or postoperative treatment for other types of solid tumors (OnkoFit II trial) will be randomized (1:1:1) into 3-arm studies. Target accrual is 201 patients in each trial (50 patients per year). After providing informed consent, patients will be randomized into a standard care arm (arm A) or 1 of 2 interventional arms (arms B and C). Patients in arms B and C will wear an activity tracker and record their daily step count in a diary. Patients in arm C will receive personalized weekly targets for their physical activity. No further instructions will be given to patients in arm B. The target daily step goals for patients in arm C will be adjusted weekly and will be increased by 10\% of the average daily step count of the past week until they reach a maximum of 6000 steps per day. Patients in arm A will not be provided with an activity tracker. The primary end point of the OnkoFit I trial is cancer-related fatigue at 3 months after the completion of radiotherapy. This will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. For the OnkoFit II trial, the primary end point is the overall quality of life, which will be assessed with the Functional Assessment of Cancer Therapy-General sum score at 6 months after treatment to allow for recovery after possible surgery. In parallel, blood samples from before, during, and after treatment will be collected in order to assess inflammatory markers. Results: Recruitment for both trials started on August 1, 2020, and to date, 49 and 12 patients have been included in the OnkoFit I and OnkoFit II trials, respectively. Both trials were approved by the institutional review board prior to their initiation. Conclusions: The OnkoFit trials test an innovative, personalized approach for the implementation of an activity tracker--guided training program for patients with cancer during radiotherapy. The program requires only a limited amount of resources. Trial Registration: ClinicalTrials.gov NCT04506476; https://clinicaltrials.gov/ct2/show/NCT04506476. ClinicalTrials.gov NCT04517019; https://clinicaltrials.gov/ct2/show/NCT04517019. International Registered Report Identifier (IRRID): DERR1-10.2196/28524 ",
doi="10.2196/28524",
url="https://www.researchprotocols.org/2021/9/e28524",
url="http://www.ncbi.nlm.nih.gov/pubmed/34550079"
}


@Article{info:doi/10.2196/26574,
author="Veldhuijzen, Evalien
and Walraven, Iris
and Belderbos, Jos{\'e}",
title="Selecting a Subset Based on the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Patient-Reported Symptom Monitoring in Lung Cancer Treatment: Mixed Methods Study",
journal="JMIR Cancer",
year="2021",
month="Sep",
day="14",
volume="7",
number="3",
pages="e26574",
keywords="PRO-CTCAE",
keywords="lung cancer",
keywords="side effects",
keywords="patient-reported outcomes",
keywords="PROM",
keywords="symptomatic adverse events",
abstract="Background: The Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item library covers a wide range of symptoms relevant to oncology care. There is a need to select a subset of items relevant to specific patient populations to enable the implementation of PRO-CTCAE--based symptom monitoring in clinical practice. Objective: The aim of this study is to develop a PRO-CTCAE--based subset relevant to patients with lung cancer that can be used for monitoring during multidisciplinary clinical practice. Methods: The PRO-CTCAE--based subset for patients with lung cancer was generated using a mixed methods approach based on the European Organization for Research and Treatment of Cancer guidelines for developing questionnaires, comprising a literature review and semistructured interviews with both patients with lung cancer and health care practitioners (HCPs). Both patients and HCPs were queried on the relevance and impact of all PRO-CTCAE items. The results were summarized, and after a final round of expert review, a selection of clinically relevant items for patients with lung cancer was made. Results: A heterogeneous group of patients with lung cancer (n=25) from different treatment modalities and HCPs (n=22) participated in the study. A final list of eight relevant PRO-CTCAE items was created: decreased appetite, cough, shortness of breath, fatigue, constipation, nausea, sadness, and pain (general). Conclusions: On the basis of the literature and both professional and patient input, a subset of PRO-CTCAE items has been identified for use in patients with lung cancer in clinical practice. Future work is needed to confirm the validity and effectiveness of this PRO-CTCAE--based lung cancer subset internationally and in real-world clinical practice settings. ",
doi="10.2196/26574",
url="https://cancer.jmir.org/2021/3/e26574",
url="http://www.ncbi.nlm.nih.gov/pubmed/34519658"
}


@Article{info:doi/10.2196/21088,
author="Keum, Jiyoung
and Chung, Jae Moon
and Kim, Youngin
and Ko, Hyunyoung
and Sung, Je Min
and Jo, Hyun Jung
and Park, Youp Jeong
and Bang, Seungmin
and Park, Woo Seung
and Song, Young Si
and Lee, Seung Hee",
title="Usefulness of Smartphone Apps for Improving Nutritional Status of Pancreatic Cancer Patients: Randomized Controlled Trial",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Aug",
day="31",
volume="9",
number="8",
pages="e21088",
keywords="pancreatic ductal adenocarcinoma",
keywords="mobile app",
keywords="nutritional support",
keywords="quality of life",
keywords="chemotherapy",
abstract="Background: Approximately 80\% of pancreatic ductal adenocarcinoma (PDAC) patients suffer from anorexia, weight loss, and asthenia. Most PDAC patients receive chemotherapy, which often worsens their nutritional status owing to the adverse effects of chemotherapy. Malnutrition of PDAC patients is known to be associated with poor prognosis; therefore, nutritional management during chemotherapy is a key factor influencing the outcome of the treatment. Mobile apps have the potential to provide readily accessible nutritional support for patients with PDAC. Objective: We aimed to evaluate the efficacy of a mobile app--based program, Noom, in patients receiving chemotherapy for PDAC. Methods: We prospectively enrolled 40 patients who were newly diagnosed with unresectable PDAC from a single university-affiliated hospital in South Korea, and randomly assigned them into a Noom user group (n=20) and a non-Noom user group (n=20). The 12-week in-app interventions included meal and physical activity logging as well as nutritional education feedback from dietitians. The non-Noom user group did not receive any nutrition intervention. The primary outcomes were the changes in the nutritional status and quality of life (QoL) from the baseline to 12 weeks. The secondary outcomes included the changes in the skeletal muscle index (SMI) from the baseline to 12 weeks. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Patient-Generated Subjective Global Assessment (PG-SGA) were used as paper questionnaires to assess the QoL and nutritional status of the patients. Intention-to-treat and per-protocol analyses were conducted. Regarding the study data collection time points, we assessed the nutritional status and QoL at the baseline (T0), and at 4 (T1), 8 (T2), and 12 (T3) weeks. Abdominal computed tomography (CT) imaging was conducted at the baseline and after 8 weeks for tumor response and SMI evaluation. The skeletal muscle area (cm2) was calculated using routine CT images. The cross-sectional areas (cm2) of the L3 skeletal muscles were analyzed. Results: Between February 2017 and January 2018, 48 patients were assessed for eligibility. Totally 40 patients with pancreatic cancer were included by random allocation. Only 17 participants in the Noom user group and 16 in the non-Noom user group completed all follow-ups. All the study participants showed a significant improvement in the nutritional status according to the PG-SGA score regardless of Noom app usage. Noom users showed statistically significant improvements on the global health status (GHS) and QoL scales compared to non-Noom users, based on the EORTC QLQ (P=.004). The SMI decreased in both groups during chemotherapy (Noom users, 49.08{\textpm}12.27 cm2/m2 to 46.08{\textpm}10.55 cm2/m2; non-Noom users, 50.60{\textpm}9.05 cm2/m2 to 42.97{\textpm}8.12 cm2/m2). The decrement was higher in the non-Noom user group than in the Noom user group, but it was not statistically significant (-13.96\% vs. -3.27\%; P=.11). Conclusions: This pilot study demonstrates that a mobile app--based approach is beneficial for nutritional and psychological support for PDAC patients receiving chemotherapy. Trial Registration: ClinicalTrials.gov NCT04109495; https://clinicaltrials.gov/ct2/show/NCT04109495. ",
doi="10.2196/21088",
url="https://mhealth.jmir.org/2021/8/e21088",
url="http://www.ncbi.nlm.nih.gov/pubmed/34463630"
}


@Article{info:doi/10.2196/28695,
author="Yang, Kyungmi
and Oh, Dongryul
and Noh, Myoung Jae
and Yoon, Gyul Han
and Sun, Jong-Mu
and Kim, Kwan Hong
and Zo, Ill Jae
and Shim, Mog Young
and Ko, Hyunyoung
and Lee, Jungeun
and Kim, Youngin",
title="Feasibility of an Interactive Health Coaching Mobile App to Prevent Malnutrition and Muscle Loss in Esophageal Cancer Patients Receiving Neoadjuvant Concurrent Chemoradiotherapy: Prospective Pilot Study",
journal="J Med Internet Res",
year="2021",
month="Aug",
day="27",
volume="23",
number="8",
pages="e28695",
keywords="esophageal cancer",
keywords="malnutrition",
keywords="muscle loss",
keywords="sarcopenia",
keywords="mobile app",
keywords="mHealth",
abstract="Background: Excessive muscle loss is an important prognostic factor in esophageal cancer patients undergoing neoadjuvant chemoradiotherapy (NACRT), as reported in our previous research. Objective: In this pilot study, we prospectively tested the feasibility of a health coaching mobile app for preventing malnutrition and muscle loss in this patient population. Methods: Between July 2019 and May 2020, we enrolled 38 male patients with esophageal cancer scheduled for NACRT. For 8 weeks from the start of radiotherapy (RT), the patients used Noom, a health coaching mobile app that interactively provided online advice about food intake, exercise, and weight changes. The skeletal muscle index (SMI) measured based on computed tomography and nutrition-related laboratory markers were assessed before and after RT. We evaluated the changes in the SMI, nutrition, and inflammatory factors between the patient group that used the mobile app (mHealth group) and our previous study cohort (usual care group). Additionally, we analyzed the factors associated with walk steps recorded in the app. Results: Two patients dropped out of the study (no app usage; treatment changed to a definitive aim). The use (or activation) of the app was noted in approximately 70\% (25/36) of the patients until the end of the trial. Compared to the 1:2 matched usual care group by propensity scores balanced with their age, primary tumor location, tumor stage, pre-RT BMI, and pre-RT SMI level, 30 operable patients showed less aggravation of the prognostic nutritional index (PNI) (--6.7 vs --9.8; P=.04). However, there was no significant difference in the SMI change or the number of patients with excessive muscle loss (?SMI/50 days >10\%). In patients with excessive muscle loss, the walk steps significantly decreased in the last 4 weeks compared to those in the first 4 weeks. Age affected the absolute number of walk steps (P=.01), whereas pre-RT sarcopenia was related to the recovery of the reduced walk steps (P=.03). Conclusions: For esophageal cancer patients receiving NACRT, a health care mobile app helped nutritional self-care with less decrease in the PNI, although it did not prevent excessive muscle loss. An individualized care model with proper exercise as well as nutritional support may be required to reduce muscle loss and malnutrition. ",
doi="10.2196/28695",
url="https://www.jmir.org/2021/8/e28695",
url="http://www.ncbi.nlm.nih.gov/pubmed/34448714"
}


@Article{info:doi/10.2196/18502,
author="Sivanandan, Ananth Mayuran
and Sharma, Catherine
and Bullard, Pippa
and Christian, Judith",
title="Digital Patient-Reported Outcome Measures for Monitoring of Patients on Cancer Treatment: Cross-sectional Questionnaire Study",
journal="JMIR Form Res",
year="2021",
month="Aug",
day="13",
volume="5",
number="8",
pages="e18502",
keywords="patient-reported outcome measures",
keywords="patient-reported outcomes",
keywords="remote monitoring",
keywords="toxicity",
keywords="outpatients",
keywords="digital technology",
keywords="digital health",
keywords="mobile health",
keywords="oncology",
keywords="chemotherapy",
keywords="immunotherapy",
keywords="radiotherapy",
abstract="Background: Oncology has been facing increasing outpatient activity associated with higher cancer incidence, better survival rates, and more treatment options. Innovative technological solutions could help deal with this increasing demand. Using digital patient-reported outcome measures (PROMs) to identify patients who need a face-to-face (FTF) appointment is a potential approach. Objective: This study aims to assess the feasibility of digital PROM questionnaires to enable remote symptom monitoring for patients undergoing cancer treatment and their ability to highlight the requirement for an FTF appointment. Methods: This study was performed at a tertiary oncology center between December 2018 and February 2019. The Common Terminology Criteria for Adverse Events were adapted into patient-friendly language to form the basis of treatment-specific digital questionnaires covering specific cancer drugs and radiotherapy treatments. These treatment-specific digital PROM questionnaires were scored by both patients and their clinicians during FTF appointments. Patients and clinicians did not see each other's scored PROMs. Agreement between patients and clinicians was assessed using descriptive statistics. Patient and staff feedback was also obtained. Results: In total, 90 patients participated in the study across 10 different treatment pathways. By comparing paired patient and clinician responses, the sensitivity of the patient-completed questionnaires in correctly highlighting the need for FTF review was 94\% (44/47), and all patients with severe or grade 3+ symptoms were identified (6/6, 100\%). Patient-completed PROMs appropriately revealed that 29\% (26/90) of the participating patients did not need FTF review based on their symptoms alone. Certain oncological treatment pathways, such as immunotherapy, were found to have a larger proportion of patients with minimal symptoms than others, such as conventional chemotherapy. Patient and staff feedback showed high approval of digital PROMs and their potential for use in remote monitoring. Conclusions: Digital PROM questionnaires can feasibly highlight the need for FTF review in oncology clinics for treatment. Their use with specific treatments could safely reduce the requirement for FTF care, and future work should evaluate their application in the remote monitoring of patients. ",
doi="10.2196/18502",
url="https://formative.jmir.org/2021/8/e18502",
url="http://www.ncbi.nlm.nih.gov/pubmed/34398785"
}


@Article{info:doi/10.2196/29271,
author="Trojan, Andreas
and Leuthold, Nicolas
and Thomssen, Christoph
and Rody, Achim
and Winder, Thomas
and Jakob, Andreas
and Egger, Claudine
and Held, Ulrike
and Jackisch, Christian",
title="The Effect of Collaborative Reviews of Electronic Patient-Reported Outcomes on the Congruence of Patient- and Clinician-Reported Toxicity in Cancer Patients Receiving Systemic Therapy: Prospective, Multicenter, Observational Clinical Trial",
journal="J Med Internet Res",
year="2021",
month="Aug",
day="5",
volume="23",
number="8",
pages="e29271",
keywords="cancer",
keywords="consilium",
keywords="app",
keywords="eHealth",
keywords="ePRO",
keywords="CTCAE",
keywords="congruency",
keywords="patient-reported",
keywords="symptoms",
abstract="Background: Electronic patient-reported outcomes (ePRO) are a relatively novel form of data and have the potential to improve clinical practice for cancer patients. In this prospective, multicenter, observational clinical trial, efforts were made to demonstrate the reliability of patient-reported symptoms. Objective: The primary objective of this study was to assess the level of agreement $\kappa$ between symptom ratings by physicians and patients via a shared review process in order to determine the future reliability and utility of self-reported electronic symptom monitoring. Methods: Patients receiving systemic therapy in a (neo-)adjuvant or noncurative intention setting captured ePRO for 52 symptoms over an observational period of 90 days. At 3-week intervals, randomly selected symptoms were reviewed between the patient and physician for congruency on severity of the grading of adverse events according to the Common Terminology Criteria of Adverse Events (CTCAE). The patient-physician agreement for the symptom review was assessed via Cohen kappa ($\kappa$), through which the interrater reliability was calculated. Chi-square tests were used to determine whether the patient-reported outcome was different among symptoms, types of cancer, demographics, and physicians' experience. Results: Among the 181 patients (158 women and 23 men; median age 54.4 years), there was a fair scoring agreement ($\kappa$=0.24; 95\% CI 0.16-0.33) for symptoms that were entered 2 to 4 weeks before the intended review (first rating) and a moderate agreement ($\kappa$=0.41; 95\% CI 0.34-0.48) for symptoms that were entered within 1 week of the intended review (second rating). However, the level of agreement increased from moderate (first rating, $\kappa$=0.43) to substantial (second rating, $\kappa$=0.68) for common symptoms of pain, fever, diarrhea, obstipation, nausea, vomiting, and stomatitis. Similar congruency levels of ratings were found for the most frequently entered symptoms (first rating: $\kappa$=0.42; second rating: $\kappa$=0.65). The symptom with the lowest agreement was hair loss ($\kappa$=--0.05). With regard to the latency of symptom entry into the review, hardly any difference was demonstrated between symptoms that were entered from days 1 to 3 and from days 4 to 7 before the intended review ($\kappa$=0.40 vs $\kappa$=0.39, respectively). In contrast, for symptoms that were entered 15 to 21 days before the intended review, no congruency was demonstrated ($\kappa$=--0.15). Congruency levels seemed to be unrelated to the type of cancer, demographics, and physicians' review experience. Conclusions: The shared monitoring and review of symptoms between patients and clinicians has the potential to improve the understanding of patient self-reporting. Our data indicate that the integration of ePRO into oncological clinical research and continuous clinical practice provides reliable information for self-empowerment and the timely intervention of symptoms. Trial Registration: ClinicalTrials.gov NCT03578731; https://clinicaltrials.gov/ct2/show/NCT03578731 ",
doi="10.2196/29271",
url="https://www.jmir.org/2021/8/e29271",
url="http://www.ncbi.nlm.nih.gov/pubmed/34383675"
}


@Article{info:doi/10.2196/27502,
author="Chen, Ciao-Sin
and Kim, Judith
and Garg, Noemi
and Guntupalli, Harsha
and Jagsi, Reshma
and Griggs, J. Jennifer
and Sabel, Michael
and Dorsch, P. Michael
and Callaghan, C. Brian
and Hertz, L. Daniel",
title="Chemotherapy-Induced Peripheral Neuropathy Detection via a Smartphone App: Cross-sectional Pilot Study",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Jul",
day="5",
volume="9",
number="7",
pages="e27502",
keywords="chemotherapy-induced peripheral neuropathy",
keywords="smartphone",
keywords="mobile health",
keywords="gait",
keywords="balance",
keywords="9-Hole Peg Test",
abstract="Background: Severe chemotherapy-induced peripheral neuropathy (CIPN) can cause long-term dysfunction of the hands and feet, interfere with activities of daily living, and diminish the quality of life. Monitoring to identify CIPN and adjust treatment before it progressing to a life-altering severity relies on patients self-reporting subjective symptoms to their clinical team. Objective assessment is not a standard component of CIPN monitoring due to the requirement for specially trained health care professionals and equipment. Smartphone apps have the potential to conveniently collect both subjective and objective CIPN data directly from patients, which could improve CIPN monitoring. Objective: The objective of this cross-sectional pilot study was to assess the feasibility of functional CIPN assessment via a smartphone app in patients with cancer that have received neurotoxic chemotherapy. Methods: A total of 26 patients who had completed neurotoxic chemotherapy were enrolled and classified as CIPN cases (n=17) or controls (n=9) based on self-report symptoms. All participants completed CIPN assessments within the NeuroDetect app a single time, including patient-reported surveys (CIPN20 [European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Chemotherapy-induced Peripheral Neuropathy 20-item scale] and PRO-CTCAE [Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events]) and functional assessments (Gait and Balance and 9-Hole Peg Test). Functional assessment data were decomposed into features. The primary analysis was done to identify features indicative of the difference between CIPN cases and controls using partial least squares analyses. Exploratory analyses were performed to test if any features were associated with specific symptom subtypes or patient-reported survey scores. Patient interviews were also conducted to understand the challenges they experienced with the app. Results: Comparisons between CIPN cases and controls indicate that CIPN cases had shorter step length (P=.007), unique swaying acceleration patterns during a walking task, and shorter hand moving distance in the dominant hands during a manual dexterity task (variable importance in projection scores ?2). Exploratory analyses showed similar signatures associated with symptoms subtypes, CIPN20, and PRO-CTCAE. The interview results showed that some patients had difficulties due to technical issues, which indicated a need for additional training or oversight during the initial app download. Conclusions: Our results supported the feasibility of remote CIPN assessment via a smartphone app and suggested that functional assessments may indicate CIPN manifestations in the hands and feet. Additional work is needed to determine which functional assessments are most indicative of CIPN and could be used for CIPN monitoring within clinical care. ",
doi="10.2196/27502",
url="https://mhealth.jmir.org/2021/7/e27502",
url="http://www.ncbi.nlm.nih.gov/pubmed/36260403"
}


@Article{info:doi/10.2196/25791,
author="Shih, Chi-Huang
and Chou, Pai-Chien
and Chou, Ting-Ling
and Huang, Tsai-Wei",
title="Measurement of Cancer-Related Fatigue Based on Heart Rate Variability: Observational Study",
journal="J Med Internet Res",
year="2021",
month="Jul",
day="5",
volume="23",
number="7",
pages="e25791",
keywords="cancer-related fatigue",
keywords="heart rate variability",
keywords="LF-HF ratio",
keywords="photoplethysmography",
keywords="wearables",
keywords="chemotherapy",
abstract="Background: Cancer-related fatigue is a serious side effect of cancer, and its treatment can disrupt the quality of life of patients. Clinically, the standard method for assessing cancer-related fatigue relies on subjective experience retrieved from patient self-reports, such as the Brief Fatigue Inventory (BFI). However, most patients do not self-report their fatigue levels. Objective: In this study, we aim to develop an objective cancer-related fatigue assessment method to track and monitor fatigue in patients with cancer. Methods: In total, 12 patients with lung cancer who were undergoing chemotherapy or targeted therapy were enrolled. We developed frequency-domain parameters of heart rate variability (HRV) and BFI based on a wearable-based HRV measurement system. All patients completed the BFI-Taiwan version questionnaire and wore the device for 7 consecutive days to record HRV parameters such as low frequency (LF), high frequency (HF), and LF-HF ratio (LF-HF). Statistical analysis was used to map the correlation between subjective fatigue and objective data. Results: A moderate positive correlation was observed between the average LF-HF ratio and BFI in the sleep phase ($\rho$=0.86). The mapped BFI score derived by the BFI mapping method could approximate the BFI from the patient self-report. The mean absolute error rate between the subjective and objective BFI scores was 3\%. Conclusions: LF-HF is highly correlated with the cancer-related fatigue experienced by patients with lung cancer undergoing chemotherapy or targeted therapy. Beyond revealing fatigue levels objectively, continuous HRV recordings through the photoplethysmography watch device and the defined parameters (LF-HF) can define the active phase and sleep phase in patients with lung cancer who undergo chemotherapy or targeted chemotherapy, allowing a deduction of their sleep patterns. ",
doi="10.2196/25791",
url="https://www.jmir.org/2021/7/e25791",
url="http://www.ncbi.nlm.nih.gov/pubmed/36260384"
}


@Article{info:doi/10.2196/30090,
author="Bandiera, Carole
and Cardoso, Evelina
and Locatelli, Isabella
and Digklia, Antonia
and Zaman, Khalil
and Diciolla, Antonella
and Cristina, Val{\'e}rie
and Stravodimou, Athina
and Veronica, Lopez Aedo
and Dolcan, Ana
and Sarivalasis, Apostolos
and Liapi, Aikaterini
and Bouchaab, Hasna
and Orcurto, Angela
and Dotta-Celio, Jennifer
and Peters, Solange
and Decosterd, Laurent
and Widmer, Nicolas
and Wagner, Dorothea
and Csajka, Chantal
and Schneider, Paule Marie",
title="Optimizing Oral Targeted Anticancer Therapies Study for Patients With Solid Cancer: Protocol for a Randomized Controlled Medication Adherence Program Along With Systematic Collection and Modeling of Pharmacokinetic and Pharmacodynamic Data",
journal="JMIR Res Protoc",
year="2021",
month="Jun",
day="29",
volume="10",
number="6",
pages="e30090",
keywords="neoplasms",
keywords="medication adherence",
keywords="oral anticancer therapies",
keywords="interprofessional program",
keywords="adherence electronic measure",
keywords="pharmacokinetics",
keywords="pharmacodynamics",
keywords="NONMEM",
keywords="motivational interviewing",
abstract="Background: The strengthening or substitution of intravenous cytotoxic chemotherapy cycles by oral targeted anticancer therapies, such as protein kinase inhibitors (PKIs), has provided impressive clinical benefits and autonomy as well as a better quality of life for patients with cancer. Despite these advances, adverse event management at home and medication adherence remain challenging. In addition, PKI plasma concentrations vary significantly among patients with cancer receiving the same dosage, which could explain part of the observed variability in the therapeutic response. Objective: The aim of this optimizing oral targeted anticancer therapies (OpTAT) study is to optimize and individualize targeted anticancer treatments to improve patient care and self-monitoring through an interprofessional medication adherence program (IMAP) combined with measurement PKI plasma concentrations. Methods: The OpTAT study has two parts: (1) a 1:1 randomized medication adherence program, in which the intervention consists of regular motivational interviewing sessions between the patient and the pharmacist, along with the delivery of PKIs in electronic monitors, and (2) a systematic collection of blood samples and clinical and biological data for combined pharmacokinetic and pharmacodynamic analysis. On the basis of the electronic monitor data, medication adherence will be compared between groups following the three operational definitions: implementation of treatment during the persistent period, persistence with treatment and longitudinal adherence. The implementation will be described using generalized estimating equation models. The persistence of PKI use will be represented using a Kaplan-Meier survival curve. Longitudinal adherence is defined as the product of persistence and implementation. PKI pharmacokinetics will be studied using a population approach. The relationship between drug exposure and efficacy outcomes will be explored using Cox regression analysis of progression-free survival. The relationship between drug exposure and toxicity will be analyzed using a pharmacokinetic-pharmacodynamic model and by logistic regression analysis. Receiver operating characteristic analyses will be applied to evaluate the best exposure threshold associated with clinical benefits. Results: The first patient was included in May 2015. As of June 2021, 262 patients had participated in at least one part of the study: 250 patients gave at least one blood sample, and 130 participated in the adherence study. Data collection is in process, and the final data analysis is planned to be performed in 2022. Conclusions: The OpTAT study will inform us about the effectiveness of the IMAP program in patients with solid cancers treated with PKIs. It will also shed light on PKI pharmacokinetic and pharmacodynamic properties, with the aim of learning how to adapt the PKI dosage at the individual patient level to increase PKI clinical suitability. The IMAP program will enable interprofessional teams to learn about patients' needs and to consider their concerns about their PKI self-management, considering the patient as an active partner. Trial Registration: ClinicalTrials.gov NCT04484064; https://clinicaltrials.gov/ct2/show/NCT04484064. International Registered Report Identifier (IRRID): DERR1-10.2196/30090 ",
doi="10.2196/30090",
url="https://www.researchprotocols.org/2021/6/e30090",
url="http://www.ncbi.nlm.nih.gov/pubmed/34185020"
}


@Article{info:doi/10.2196/25035,
author="Jeon, Hokyun
and You, Chan Seng
and Kang, Yun Seok
and Seo, In Seung
and Warner, L. Jeremy
and Belenkaya, Rimma
and Park, Woong Rae",
title="Characterizing the Anticancer Treatment Trajectory and Pattern in Patients Receiving Chemotherapy for Cancer Using Harmonized Observational Databases: Retrospective Study",
journal="JMIR Med Inform",
year="2021",
month="Apr",
day="6",
volume="9",
number="4",
pages="e25035",
keywords="antineoplastic combined chemotherapy protocols",
keywords="electronic health record",
keywords="cancer",
keywords="pattern",
keywords="chemotherapy",
keywords="database",
keywords="retrospective",
keywords="algorithm",
keywords="scalability",
keywords="interoperability",
abstract="Background: Accurate and rapid clinical decisions based on real-world evidence are essential for patients with cancer. However, the complexity of chemotherapy regimens for cancer impedes retrospective research that uses observational health databases. Objective: The aim of this study is to compare the anticancer treatment trajectories and patterns of clinical events according to regimen type using the chemotherapy episodes determined by an algorithm. Methods: We developed an algorithm to extract the regimen-level abstracted chemotherapy episodes from medication records in a conventional Observational Medical Outcomes Partnership (OMOP) common data model (CDM) database. The algorithm was validated on the Ajou University School Of Medicine (AUSOM) database by manual review of clinical notes. Using the algorithm, we extracted episodes of chemotherapy from patients in the EHR database and the claims database. We also developed an application software for visualizing the chemotherapy treatment patterns based on the treatment episodes in the OMOP-CDM database. Using this software, we generated the trends in the types of regimen used in the institutions, the patterns of the iterative chemotherapy use, and the trajectories of cancer treatment in two EHR-based OMOP-CDM databases. As a pilot study, the time of onset of chemotherapy-induced neutropenia according to regimen was measured using the AUSOM database. The anticancer treatment trajectories for patients with COVID-19 were also visualized based on the nationwide claims database. Results: We generated 178,360 treatment episodes for patients with colorectal, breast, and lung cancer for 85 different regimens. The algorithm precisely identified the type of chemotherapy regimen in 400 patients (average positive predictive value >98\%). The trends in the use of routine clinical chemotherapy regimens from 2008-2018 were identified for 8236 patients. For a total of 12 regimens (those administered to the largest proportion of patients), the number of repeated treatments was concordant with the protocols for standard chemotherapy regimens for certain cases. In addition, the anticancer treatment trajectories for 8315 patients were shown, including 62 patients with COVID-19. A comparative analysis of neutropenia showed that its onset in colorectal cancer regimens tended to cluster between days 9-15, whereas it tended to cluster between days 2-8 for certain regimens for breast cancer or lung cancer. Conclusions: We propose a method for generating chemotherapy episodes for introduction into the oncology extension module of the OMOP-CDM databases. These proof-of-concept studies demonstrated the usability, scalability, and interoperability of the proposed framework through a distributed research network. ",
doi="10.2196/25035",
url="https://medinform.jmir.org/2021/4/e25035",
url="http://www.ncbi.nlm.nih.gov/pubmed/33720842"
}


@Article{info:doi/10.2196/24893,
author="Heneghan, B. Mallorie
and Hussain, Tasmeen
and Barrera, Leonardo
and Cai, W. Stephanie
and Haugen, Maureen
and Morgan, Elaine
and Rossoff, Jenna
and Weinstein, Joanna
and Hijiya, Nobuko
and Cella, David
and Badawy, M. Sherif",
title="Access to Technology and Preferences for an mHealth Intervention to Promote Medication Adherence in Pediatric Acute Lymphoblastic Leukemia: Approach Leveraging Behavior Change Techniques",
journal="J Med Internet Res",
year="2021",
month="Feb",
day="18",
volume="23",
number="2",
pages="e24893",
keywords="acute lymphoblastic leukemia",
keywords="medication adherence",
keywords="behavior change technique",
keywords="oral chemotherapy",
keywords="mHealth",
keywords="patient-centered",
abstract="Background: Suboptimal adherence to 6-mercaptopurine (6-MP) is prevalent in pediatric acute lymphoblastic leukemia (ALL) and associated with increased risk of relapse. Rapid uptake of personal technology makes mobile health (mHealth) an attractive platform to promote adherence. Objective: Study objectives were to examine access to mobile technology and preferences for an mHealth intervention to improve medication adherence in pediatric ALL. Methods: A cross-sectional survey was administered in oncology clinic to parents of children with ALL as well as adolescents and young adults (AYAs) with ALL receiving maintenance chemotherapy. Results: A total of 49 parents (median age [IQR] 39 [33-42] years; female 76\% [37/49]) and 15 patients (median age [IQR] 17 [16-19]; male 80\% [12/15]) participated. All parents and AYAs owned electronic tablets, smartphones, or both. Parents' most endorsed mHealth app features included a list of medications (71\%, 35/49), information about 6-MP (71\%, 35/49), refill reminders (71\%, 35/49), and reminders to take 6-MP (71\%, 35/49). AYAs' most endorsed features included refill reminders (73\%, 11/15), reminders to take 6-MP (73\%, 11/15), and tracking 6-MP (73\%, 11/15). Conclusions: Parents and AYAs reported ubiquitous access to mobile technology and strong interest in multiple adherence-specific mHealth app features. Parents and AYAs provided valuable insight into preferred features for a multifunctional behavioral intervention (mHealth app) to promote medication adherence in pediatric ALL. ",
doi="10.2196/24893",
url="http://www.jmir.org/2021/2/e24893/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33599621"
}


@Article{info:doi/10.2196/19727,
author="Vogel, E. Marco M.
and Eitz, A. Kerstin
and Combs, E. Stephanie",
title="Web-Based Patient Self-Reported Outcome After Radiotherapy in Adolescents and Young Adults With Cancer: Survey on Acceptance of Digital Tools",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Jan",
day="11",
volume="9",
number="1",
pages="e19727",
keywords="mHealth",
keywords="eHealth",
keywords="young adults",
abstract="Background: eHealth and mobile health (mHealth) are an evolving trend in the medical field. The acceptance of digital tools is high, and the need is growing. Objective: Young adults (18-40 years) confronted with a cancer diagnosis present unique needs and require special care. They often have a strong affinity and are familiar with modern technology. On that account, we implemented a web-based symptom and quality of life (QoL) assessment to address patients' attitudes and willingness to use mHealth tools. The study also aims to evaluate sociodemographic parameters that could influence patients' opinions. Methods: A total of 380 young patients aged 18-40 treated with radiotherapy between 2002 and 2017 were included in the trial. We assessed QoL via the European Organization for Research and Treatment of Cancer-Core 30 (EORTC C30) questionnaire and added general questions about mHealth technology. The added questions inquired patients' opinions regarding general aspects, including technical advances in medicine, mobile and app assistance during cancer treatment, data transfer, and app-specific features. The survey was conducted for 12 months. Participation was voluntary and pseudonymized; prior written consent was obtained. Results: We achieved a participation rate of 57.6\% (219/380) and a completion rate of 50.2\% (110/219). The median age was 33 years (range 18-40). Of all participants, 89.1\% (98/110) considered new technologies in medicine as positive; 10.9\% (12/110) answered with neutral. Nearly all patients (96.4\%, 106/110) stated that they would send further data via a web-based platform. Of all, 96.4\% (106/110) considered the provided pseudonymization of their data as safe. We further asked the patients if they would use a mobile app for symptom and QoL assessment similar to the present web-based system: 74.5\% (82/110) answered with yes and 25.5\% (28/110) said they would not use a mobile app in the future. We tested the willingness to use an app on several sociodemographic parameters, such as age, gender, education, health insurance status, and cancer-related parameters: tumor stage, time since radiation treatment, and treatment intention. None of these parameters correlated with app use in this group of young adults. Patients who were generally positive regarding using an app rated several possible functions of a future app. The 3 most requested features were appointment reminders (89.0\%, 73/82), contact overview of all involved clinics and physicians (87\%, 71/82), and making an appointment via app (78\%, 64/82). Conclusions: eHealth and mHealth tools should be available as an integrated part of a comprehensive cancer care approach. It provides automated, thorough documentation of health parameters during therapy and follow-up for doctors, medical staff, and tumor patients to optimize treatment. With this study, we could show that young adults are the ideal patient population to use eHealth/mHealth tools. Such tools offer further digital support and improve the patients' need for constant QoL during cancer care. ",
doi="10.2196/19727",
url="http://mhealth.jmir.org/2021/1/e19727/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33427669"
}


@Article{info:doi/10.2196/20636,
author="Kongshaug, Nina
and Skolbekken, John-Arne
and Faxvaag, Arild
and Hofsli, Eva",
title="Cancer Patients' Perceived Value of a Smartphone App to Enhance the Safety of Home-Based Chemotherapy:  Feasibility Study",
journal="JMIR Form Res",
year="2021",
month="Jan",
day="6",
volume="5",
number="1",
pages="e20636",
keywords="mhealth",
keywords="mobile app",
keywords="smartphone app",
keywords="oral chemotherapy",
keywords="patient safety",
keywords="home-based cancer treatment",
abstract="Background: Oral anticancer therapies can be self-administered by patients outside the hospital setting, which poses challenges of adherence to a drug plan and monitoring of side effects. Modern information technology may be developed and implemented to address these pertinent issues. Objective: The aim of this study was to explore how a smartphone app developed through a stepwise, iterative process can help patients using oral chemotherapy to take their drug, and to report adherence and side effects in a reliable and verifiable manner. Methods: Fourteen patients starting capecitabine treatment were included in this study and used the smartphone app in addition to regular follow up of capecitabine treatment. Nine of these patients fulfilled the treatment plan and were interviewed based on a semistructured interview guide and the System Usability Scale (SUS). In addition, two focus groups were completed with 7 oncologists and 7 oncology nurses, respectively. Interview data were analyzed in accordance with the principles of systematic text condensation. Features of the app were also assessed. Results: The smartphone app provided the patients with a feeling of reassurance regarding correct adherence of their oral chemotherapy treatment. They used the app as a memory tool about their treatment and possible serious side effects, as well as for treatment education. Patients expressed concerns about using the app to report side effects that were not considered to be obviously serious, fearing overreporting. The health personnel expressed an overall positive attitude to integrate this new tool in their everyday work. Conclusions: Patients on oral chemotherapy treatment at home felt safe and found the app to be helpful. The app promoted learning about their treatment and made the patients more independent of the cancer clinic, reducing the need for the clinic's limited resources for follow up of patients on oral anticancer medications. ",
doi="10.2196/20636",
url="https://formative.jmir.org/2021/1/e20636",
url="http://www.ncbi.nlm.nih.gov/pubmed/33404505"
}


@Article{info:doi/10.2196/21693,
author="Sprave, Tanja
and Z{\"o}ller, Daniela
and Stoian, Raluca
and R{\"u}hle, Alexander
and Kalckreuth, Tobias
and Haehl, Erik
and Fahrner, Harald
and Binder, Harald
and Grosu, Anca-Ligia
and Heinemann, Felix
and Nicolay, Henrik Nils",
title="App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients (APCOT): Protocol for a Prospective Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2020",
month="Dec",
day="9",
volume="9",
number="12",
pages="e21693",
keywords="mHealth",
keywords="head and neck cancer",
keywords="HNSCC",
keywords="radiotherapy",
keywords="mobile app",
keywords="quality of life",
keywords="patient-reported outcome measures",
abstract="Background: Head and neck cancers (HNCs) are among the most common malignancies, which often require multimodal treatment that includes radiation therapy and chemotherapy. Patients with HNC have a high burden of symptoms due to both the damaging effects of the tumor and the aggressive multimodal treatment. Close symptom monitoring over the course of the disease may help to identify patients in need of medical interventions. Objective: This APCOT (App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients) trial is designed to assess the feasibility of monitoring HNC patients during the course of (chemo)radiation therapy daily using a mobile app. Additionally, symptom patterns, patient satisfaction, and quality of life will be measured in app-monitored patients in comparison to a patient cohort receiving standard-of-care physician appointments, and health economy aspects of app monitoring will be analyzed. Methods: This prospective randomized single-center trial will evaluate the feasibility of integrating electronic patient-reported outcome measures (ePROMs) into the treatment workflow of HNC patients. Patients undergoing definitive or adjuvant (chemo)radiation therapy as part of their HNC treatment at the Department of Radiation Oncology, University Medical Center Freiburg (Freiburg, Germany) will receive weekly physician appointments and additional appointments as requested to monitor and potentially treat symptoms during the course of treatment. Patients in the experimental arm will additionally be monitored daily using a dedicated app regarding their disease- and treatment-related symptoms, quality of life, and need for personal physician appointments. The feasibility of ePROM monitoring will be tested as the primary endpoint and will be defined if ?80\% of enrolled patients have answered ?80\% of their daily app-based questions. Quality of life will be assessed using the validated European Organisation for Research and Treatment of Cancer questionnaires, and patient satisfaction will be measured by the validated Patient Satisfaction Questionnaire Short Form at the initiation, in the middle, and at completion of radiation therapy, as well as at follow-up examinations. Additionally, the number and duration of physician appointments during the course of radiation therapy will be quantified for both ePROM-monitored and standard-of-care patients. Results: This trial will enroll 100 patients who will be randomized (1:1) between the experimental arm with ePROM monitoring and the control arm with standard patient care. Recruitment will take 18 months, and trial completion is planned at 24 months after enrollment of the last patient. Conclusions: This trial will establish the feasibility of close ePROM monitoring of HNC patients undergoing (chemo)radiation therapy. The results can form the basis for further trials investigating potential clinical benefits of detailed symptom monitoring and patient-centered care in HNC patients regarding oncologic outcomes and quality of life. Trial Registration: German Clinical Trials Register DRKS00020491; https://www.drks.de/drks\_web/navigate.do?navigationId=trial.HTML\&TRIAL\_ID=DRKS00020491 International Registered Report Identifier (IRRID): PRR1-10.2196/21693 ",
doi="10.2196/21693",
url="https://www.researchprotocols.org/2020/12/e21693",
url="http://www.ncbi.nlm.nih.gov/pubmed/33295291"
}


@Article{info:doi/10.2196/22825,
author="Whitehead, Lisa
and Emery, Laura
and Kirk, Deborah
and Twigg, Diane
and Brown, Deborah
and Dewar, Joanna",
title="Evaluation of a Remote Symptom Assessment and Management (SAM) System for People Receiving Adjuvant Chemotherapy for Breast or Colorectal Cancer: Mixed Methods Study",
journal="JMIR Cancer",
year="2020",
month="Dec",
day="7",
volume="6",
number="2",
pages="e22825",
keywords="self-management",
keywords="intervention",
keywords="symptom management",
keywords="breast cancer",
keywords="colorectal cancer",
keywords="cancer",
keywords="symptom",
keywords="monitoring",
keywords="online intervention",
keywords="development",
keywords="implementation",
keywords="evaluation",
abstract="Background: The Symptom Assessment and Management (SAM) program is a structured, online, nurse-supported intervention to support symptom self-management in people receiving adjuvant chemotherapy post surgery for breast or colorectal cancer. Objective: The objective of this study was to describe the development, implementation strategy, and evaluation of the SAM system. Methods: The development of the SAM program involved 3 phases. In phase 1, the web app was developed through consultation with consumers and clinicians and of the literature to ensure that the system was evidence-based and reflected the realities of receiving treatment and supporting patients through treatment. In phase 2, 7 participants recorded the severity of 6 symptoms daily over the course of 1 cycle of chemotherapy. In phase 3, 17 participants recorded their symptoms daily over the course of 3 cycles of chemotherapy. Once symptoms were recorded, participants received immediate feedback on the severity of their symptoms and self-management recommendations, which could include seeking immediate medical attention. Data on quality of life, symptom burden, anxiety and depression, distress, and self-efficacy were collected during treatment; participants' perceptions of the SAM program were evaluated following participation via interview. Results: The outcomes of the SAM project include the development of a system that is reliable and easy to use and navigate. Participants reported benefits related to using the SAM program that included feeling more in control of managing their symptoms and feeling reassured. Engagement with the system on a daily basis was variable, with some participants completing the symptom tracker daily and others engaging some of the time. The feedback from all participants was that the system was easy to navigate and the information was relevant and supportive. Conclusions: The SAM program has the potential to enhance the management of symptoms for people receiving chemotherapy treatment. The system creates an accurate repository of symptoms that can be accessed easily and highlight patterns in symptom experience. These can be shared with clinicians, with patient permission, to inform and support treatment plans. The potential to predict the risk of developing severe symptoms can be developed to anticipate the need for care and support. Further considerations on how to increase engagement with the system, the value of the system for people diagnosed with other tumor types and treatment regimes, and the incorporation of the system into everyday clinical practice are needed. ",
doi="10.2196/22825",
url="http://cancer.jmir.org/2020/2/e22825/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33284122"
}


@Article{info:doi/10.2196/19225,
author="Jones, V. Helen
and Smith, Harry
and Cooksley, Tim
and Jones, Philippa
and Woolley, Toby
and Gwyn Murdoch, Derick
and Thomas, Dafydd
and Foster, Betty
and Wakefield, Valerie
and Innominato, Pasquale
and Mullard, Anna
and Ghosal, Niladri
and Subbe, Christian",
title="Checklists for Complications During Systemic Cancer Treatment Shared by Patients, Friends, and Health Care Professionals: Prospective Interventional Cohort Study",
journal="JMIR Mhealth Uhealth",
year="2020",
month="Sep",
day="25",
volume="8",
number="9",
pages="e19225",
keywords="cancer",
keywords="patient safety",
keywords="checklist",
keywords="quality of life",
keywords="anxiety",
keywords="depression",
keywords="health economics",
keywords="mHealth",
keywords="smartphone",
keywords="redundancy",
abstract="Background: Advances in cancer management have been associated with an increased incidence of emergency presentations with disease- or treatment-related complications. Objective: This study aimed to measure the ability of patients and members of their social network to complete checklists for complications of systemic treatment for cancer and examine the impact on patient-centered and health-economic outcomes. Methods: A prospective interventional cohort study was performed to assess the impact of a smartphone app used by patients undergoing systemic cancer therapy and members of their network to monitor for common complications. The app was used by patients, a nominated ``safety buddy,'' and acute oncology services. The control group was made up of patients from the same institution. Measures were based on process (completion of checklists over 60 days), patient experience outcomes (Hospital Anxiety and Depression Scale and the General version of the Functional Assessment of Cancer Therapy at baseline, 1 month, and 2 months) and health-economic outcomes (usage of appointments in primary care and elective and unscheduled hospital admissions). Results: At the conclusion of the study, 50 patients had completed 2882 checklists, and their 50 ``safety buddies'' had completed 318 checklists. Near daily usage was maintained over the 60-day study period. When compared to a cohort of 50 patients with matching disease profiles from the same institution, patients in the intervention group had comparable changes in Hospital Anxiety and Depression Scale and General version of the Functional Assessment of Cancer Therapy. Patients in the Intervention Group required a third (32 vs 97 nights) of the hospital days with overnight stay compared to patients in the Control Group, though the difference was not significant. The question, ``I feel safer with the checklist,'' received a mean score of 4.27 (SD 0.87) on a Likert scale (1-5) for patients and 4.55 (SD 0.65) for family and friends. Conclusions: Patients undergoing treatment for cancer and their close contacts can complete checklists for common complications of systemic treatments and take an active role in systems supporting their own safety. A larger sample size will be needed to assess the impact on clinical outcomes and health economics. ",
doi="10.2196/19225",
url="http://mhealth.jmir.org/2020/9/e19225/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32975526"
}


@Article{info:doi/10.2196/18896,
author="Zhu, Haihua
and Chen, Xiuwan
and Yang, Jinqiu
and Wu, Qiaoling
and Zhu, Jiemin
and Chan, Wai-Chi Sally",
title="Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 3): Secondary Data Analysis",
journal="JMIR Mhealth Uhealth",
year="2020",
month="Sep",
day="16",
volume="8",
number="9",
pages="e18896",
keywords="breast cancer",
keywords="chemotherapy",
keywords="mobile app",
keywords="mHealth",
abstract="Background: Many app-based interventions targeting women with breast cancer have been developed and tested for effectiveness. However, information regarding the evaluation of the usage of these interventions is scarce. A better understanding of usage data is important to determine how women use apps and how these interventions affect health outcomes. Objective: This study aimed to examine the usage duration and login frequency of an app-based intervention, the Breast Cancer e-Support (BCS) program, and to investigate the association between usage data and participants' demographic and medical characteristics. Methods: This study is a secondary data analysis of a randomized controlled trial assessing the effectiveness of the BCS program. The BCS program contains four modules: Learning Forum, Discussion Forum, Ask-the-Expert Forum, and Your Story Forum. A total of 57 women in the intervention group accessed the BCS program during their 12-week chemotherapy. The app's background system tracked the usage duration and login frequency for each forum and the entire BCS program. Results: The total usage duration per participant ranged from 0 to 9371 minutes, and the login frequency per participant ranged from 0 to 774 times. The Discussion Forum and the Learning Forum were the most frequently used modules. The general linear model showed that age, education, family monthly income, and employment were associated with BCS usage duration and/or login frequency. Age (F1,45=10.09, P=.003, B=115.34, 95\% CI 42.22-188.47) and education level (F1,45=7.22, P=.01, B=1949.63, 95\% CI 487.76-3411.50) were positively associated with the usage duration of the entire BCS program. Family monthly income was positively associated with the usage duration of the Learning Forum (F1,45=11.85, P=.001, B=1488.55, 95\% CI 617.58-2359.51) and the login frequency of the entire BCS program (F1,45=4.47, P=.04, B=113.68, 95\% CI 5.33-222.03). Employment was negatively associated with the usage duration of the Ask-the-expert Forum (F1,45=4.50, P=.04, B=--971.87, 95\% CI --1894.66 to --49.07) and the Your Story Forum (F1,45=5.36, P=.03, B=--640.71, 95\% CI --1198.30 to --83.11) and positively associated with the login frequency of the entire BCS program (F1,45=10.86, P=.002, B=192.88, 95\% CI 75.01-310.74). No statistical differences were found between BCS usage data and cancer stage, BMI, comorbidity, types of surgery, or cycles of chemotherapy. Conclusions: Overall, this study found considerable variability in the usage of app-based interventions. When health care professionals incorporate app-based interventions into their routine care for women with breast cancer, the learning and discussion functions of apps should be strengthened to promote engagement. Additionally, characteristics of women with breast cancer, such as age, level of education, income, and employment status, should be taken in consideration to develop tailored apps that address their particular needs and therefore improve their engagement with the app. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000639426; http://www.ANZCTR.org.au/ACTRN12616000639426.aspx ",
doi="10.2196/18896",
url="http://mhealth.jmir.org/2020/9/e18896/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32936087"
}


@Article{info:doi/10.2196/17058,
author="Crafoord, Marie-Ther{\'e}se
and Fjell, Maria
and Sundberg, Kay
and Nilsson, Marie
and Langius-Ekl{\"o}f, Ann",
title="Engagement in an Interactive App for Symptom Self-Management during Treatment in Patients With Breast or Prostate Cancer: Mixed Methods Study",
journal="J Med Internet Res",
year="2020",
month="Aug",
day="10",
volume="22",
number="8",
pages="e17058",
keywords="engagement",
keywords="adherence",
keywords="mHealth",
keywords="mobile app",
keywords="cancer supportive care",
keywords="symptom management",
keywords="usage metrics",
keywords="breast cancer",
keywords="prostate cancer",
abstract="Background: Using mobile technology for symptom management and self-care can improve patient-clinician communication and clinical outcomes in patients with cancer. The interactive app Interaktor has been shown to reduce symptom burden during cancer treatment. It includes symptom assessment, an alert system for contact with health care professionals, access to self-care advice, and visualization of symptom history. It is essential to understand how digital interventions operate; one approach is to examine engagement by assessing usage and exploring user experiences. Actual usage in relation to the intended use---adherence---is an essential factor of engagement. Objective: This study aimed to describe engagement with the Interaktor app among patients with breast or prostate cancer during treatment. Methods: Patients from the intervention groups of two separate randomized controlled trials were included: patients with breast cancer receiving neoadjuvant chemotherapy (n=74) and patients with locally advanced prostate cancer receiving treatment with radiotherapy (n=75). The patients reported their symptoms daily. Sociodemographic and clinical data were obtained from baseline questionnaires and medical records. Logged data usage was retrieved from the server and analyzed descriptively and with multiple regression analysis. Telephone interviews were conducted with patients about their perceptions of using the app and analyzed using content analysis. Results: The median adherence percentage to daily symptom reporting was 83\%. Most patients used the self-care advice and free text message component. Among the patients treated for breast cancer, higher age predicted a lower total number of free text messages sent (P=.04). Among the patients treated for prostate cancer, higher age (P=.01) and higher education level (P=.04), predicted an increase in total views on self-care advice, while higher comorbidity (P=.004) predicted a decrease in total views on self-care advice. Being married or living with a partner predicted a higher adherence to daily symptom reporting (P=.02). Daily symptom reporting created feelings of having continuous contact with health care professionals, being acknowledged, and safe. Being contacted by a nurse after a symptom alert was considered convenient and highly valued. Treatment and time-related aspects influenced engagement. Daily symptom reporting was perceived as particularly meaningful at the beginning of treatment. Requests were made for advice on diet and psychological symptoms, as well as for more comprehensive and detailed information as the patient progressed through treatment. Conclusions: Patient engagement in the interactive app Interaktor was high. The app promoted patient participation in their care through continuous and convenient contact with health care professionals. The predictive ability of demographic variables differed between patient groups, but higher age and a higher educational level predicted usage of specific app functions for both patient groups. Patients' experience of relevance and interactivity influenced their engagement positively. ",
doi="10.2196/17058",
url="https://www.jmir.org/2020/8/e17058",
url="http://www.ncbi.nlm.nih.gov/pubmed/32663140"
}


@Article{info:doi/10.2196/13979,
author="Alghamdi, Abdulrahman
and Abumelha, Khalid
and Allarakia, Jawad
and Al-Shehri, Ahmed",
title="Conversations and Misconceptions About Chemotherapy in Arabic Tweets: Content Analysis",
journal="J Med Internet Res",
year="2020",
month="Jul",
day="29",
volume="22",
number="7",
pages="e13979",
keywords="internet",
keywords="chemotherapy",
keywords="cancer",
keywords="Twitter",
keywords="social media",
keywords="Arab world",
keywords="misconceptions",
keywords="infodemiology",
keywords="infoveillance",
abstract="Background: Although chemotherapy was first introduced for the treatment of cancer more than 60 years ago, the public understanding and acceptance of chemotherapy is still debatable. To the best of our knowledge, no study has assessed the conversations and misconceptions about chemotherapy as a treatment for cancer on social media platforms among the Arabic-speaking populations. Objective: The aim of this study was to assess the types of conversations and misconceptions that were shared on Twitter regarding chemotherapy as a treatment for cancer among the Arabic-speaking populations. Methods: All Arabic tweets containing any of the representative set of keywords related to chemotherapy and written between May 1, 2017 and October 31, 2017 were retrieved. A manual content analysis was performed to identify the categories of the users, general themes of the tweets, and the common misconceptions about chemotherapy. A chi-square test for independence with adjusted residuals was used to assess the significant associations between the categories of the users and the themes of the tweets. Results: A total of 402,157 tweets were retrieved, of which, we excluded 309,602 retweets and 62,651 irrelevant tweets. Therefore, 29,904 tweets were included in the final analysis. The majority of the tweets were posted by general users (25,774/29,904, 86.2\%), followed by the relatives and friends of patients with cancer (1913/29,904, 6.4\%). The tweets were classified into 9 themes; prayers and wishes for the well-being of patients undergoing chemotherapy was the most common theme (20,288/29,904, 67.8\%), followed by misconceptions about chemotherapy (2084/29,904, 7.0\%). There was a highly significant association between the category of the users and the themes of the tweets ($\chi$240= 16904.4, P<.001). Conclusions: Our findings support those of the previous infodemiology studies that Twitter is a valuable social media platform for assessing public conversations, discussions, and misconceptions about various health-related topics. The most prevalent theme of the tweets in our sample population was supportive messages for the patients undergoing chemotherapy, thereby suggesting that Twitter could play a role as a support mechanism for such patients. The second most prevalent theme of the tweets in our study was the various misconceptions about chemotherapy. The findings of our exploratory analysis can help physicians and health care organizations tailor educational efforts in the future to address different misconceptions about chemotherapy, thereby leading to increased public acceptance of chemotherapy as a suitable mode of treatment for cancer. ",
doi="10.2196/13979",
url="http://www.jmir.org/2020/7/e13979/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32723724"
}


@Article{info:doi/10.2196/18564,
author="Eliasen, Astrid
and Abildtoft, Kramme Mikkel
and Krogh, Steen Niels
and Rechnitzer, Catherine
and Brok, Sune Jesper
and Mathiasen, Ren{\'e}
and Schmiegelow, Kjeld
and Dalhoff, Peder Kim",
title="Smartphone App to Self-Monitor Nausea During Pediatric Chemotherapy Treatment: User-Centered Design Process",
journal="JMIR Mhealth Uhealth",
year="2020",
month="Jul",
day="20",
volume="8",
number="7",
pages="e18564",
keywords="mobile applications",
keywords="patient-reported outcome measures",
keywords="patient compliance",
keywords="neoplasms",
keywords="antiemetics",
keywords="nausea",
keywords="vomiting",
keywords="cancer",
keywords="children",
keywords="app",
abstract="Background: Nausea and vomiting are common and distressing side effects for children receiving chemotherapy. Limited evidence is available to guide antiemetic recommendations; therefore, prospective and reliable evaluation of antiemetic efficacy is needed. Smartphone apps can be used to effortlessly and precisely collect patient-reported outcomes in real time. Objective: Our objective was to develop a smartphone app to monitor nausea and vomiting episodes in pediatric cancer patients aged 0 to 18 years and to test its usability and adherence to its use. Methods: We used a user-centered design process and the evolutionary prototype model to develop and evaluate the app. Multidisciplinary group discussions and several rounds of patient feedback and modification were conducted. We translated the validated Pediatric Nausea Assessment Tool to assess nausea severity in children aged 4 to 18 years. The child's own term for nausea was interactively incorporated in the nausea severity question, with response options expressed as 4 illustrative faces. Parent-reported outcomes were used for children aged 0 to 3 years. Reminders were sent using push notifications in order to ensure high response rates. Children aged 0 to 18 years who were undergoing chemotherapy were recruited from the Department of Pediatric Oncology at Copenhagen University Hospital Rigshospitalet to evaluate the app. Results: The app's most important function was to record nausea severity in children. After assistance from a researcher, children aged 4 to 18 years were able to report their symptoms in the app, and parents were able to report symptoms for their children aged 0 to 3 years. Children (n=20, aged 2.0-17.5 years) and their parents evaluated the app prospectively during a collective total of 60 chemotherapy cycles. They expressed that the app was user-friendly, intuitive, and that the time spent on data entry was fair. The response rates were on average 92\%, 93\%, and 80\% for the day before, the first day of, and the next 3 days after chemotherapy, respectively. Researchers and clinicians were able to obtain an overview of the patient's chemotherapy dates and responses through a secure and encrypted web-based administrative portal. Data could be downloaded for further analysis. Conclusions: The user-friendly app could be used to facilitate future pediatric antiemetic trials and to refine antiemetic treatment during chemotherapy. ",
doi="10.2196/18564",
url="https://mhealth.jmir.org/2020/7/e18564",
url="http://www.ncbi.nlm.nih.gov/pubmed/32706744"
}


@Article{info:doi/10.2196/17232,
author="Murat-Ringot, Audrey
and Souquet, Jean Pierre
and Chauvenet, Marion
and Rentler, Charlotte
and Subtil, Fabien
and Schott, Anne-Marie
and Preau, Marie
and Piriou, Vincent",
title="The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2020",
month="Jul",
day="14",
volume="9",
number="7",
pages="e17232",
keywords="cancer",
keywords="randomized controlled trial",
keywords="foot reflexology",
keywords="nausea",
keywords="vomiting",
keywords="chemotherapy",
abstract="Background: The side effects of chemotherapy, specifically chemotherapy-induced nausea and vomiting, are a concern for patients. To relieve these side effects, antiemetic drugs are recommended. However, some patients report that these drugs are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in complementary and alternative medicines, and express the desire for nonpharmacological treatments to be used in hospitals. Foot reflexology is a holistic approach that is reported to significantly reduce the severity of chemotherapy-induced nausea and vomiting in patients with breast cancer. Some of the chemotherapy treatments for patients with lung and digestive system cancer are moderately or highly emetic. Objective: The primary objective of this study is to assess the benefits of foot reflexology, together with conventional treatments, on the severity and frequency of chemotherapy-induced nausea and vomiting in patients with lung or digestive system cancer. The secondary objectives to be assessed are quality of life, anxiety, and self-esteem. Methods: This study is an open-label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive system cancer with an indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient basis. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogue scale, and the frequency of these side effects between the two groups. The secondary objectives will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Hospital and Anxiety Depression Scale; and Body Image Questionnaire. Results: This study was approved by the regional ethics committee ({\^I}le de France X CPP) on April 3, 2018 (No. ID RCB 2018-A00571-54). Enrollment started in June 2018. Data analysis will be performed during the second quarter of 2020 and results will be published in the last quarter of 2020. Conclusions: The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend it for this use. This study will provide evidence of the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs. Trial Registration: Clinicaltrials.gov NCT03508180; https://www.clinicaltrials.gov/ct2/show/NCT03508180. International Registered Report Identifier (IRRID): DERR1-10.2196/17232 ",
doi="10.2196/17232",
url="https://www.researchprotocols.org/2020/7/e17232",
url="http://www.ncbi.nlm.nih.gov/pubmed/32449505"
}


@Article{info:doi/10.2196/17724,
author="Schindera, Christina
and Kuehni, Elisabeth Claudia
and Pavlovic, Mladen
and Haegler-Laube, Simona Eva
and Rhyner, Daniel
and Waespe, Nicolas
and Roessler, Jochen
and Suter, Thomas
and von der Weid, Xavier Nicolas",
title="Diagnosing Preclinical Cardiac Dysfunction in Swiss Childhood Cancer Survivors: Protocol for a Single-Center Cohort Study",
journal="JMIR Res Protoc",
year="2020",
month="Jun",
day="10",
volume="9",
number="6",
pages="e17724",
keywords="cardiotoxicity",
keywords="Switzerland",
keywords="echocardiography",
keywords="speckle tracking",
keywords="strain",
keywords="anthracyclines",
keywords="alkylating agents",
keywords="steroids",
keywords="cardiac radiation",
abstract="Background: Cardiovascular disease is the leading nonmalignant cause of late deaths in childhood cancer survivors. Cardiovascular disease and cardiac dysfunction can remain asymptomatic for many years, but eventually lead to progressive disease with high morbidity and mortality. Early detection and intervention are therefore crucial to improve outcomes. Objective: In our study, we aim to assess the prevalence of preclinical cardiac dysfunction in adult childhood cancer survivors using conventional and speckle tracking echocardiography; determine the association between cardiac dysfunction and treatment-related risk factors (anthracyclines, alkylating agents, steroids, cardiac radiation) and modifiable cardiovascular risk factors (abdominal obesity, hypertension); investigate the development of cardiac dysfunction longitudinally in a defined cohort; study the association between cardiac dysfunction and other health outcomes like pulmonary disease, endocrine disease, renal disease, quality of life, fatigue, strength and endurance, and physical activity; and gain experience conducting a clinical study of childhood cancer survivors that will be extended to a national, multicenter study of cardiac complications. Methods: For this retrospective cohort study, we will invite ?5-year childhood cancer survivors who were treated at the University Children's Hospital Bern, Switzerland with any chemotherapy or cardiac radiation since 1976 and who are ?18 years of age at the time of the study for a cardiac assessment at the University Hospital Bern. This includes 544 childhood cancer survivors, of whom about half were treated with anthracyclines and/or cardiac radiation and half with any other chemotherapy. The standardized cardiac assessment includes a medical history focusing on signs of cardiovascular disease and its risk factors, a physical examination, anthropometry, vital parameters, the 1-minute sit-to-stand test, and echocardiography including 2-dimensional speckle tracking. Results: We will invite 544 eligible childhood cancer survivors (median age at the time of the study, 32.5 years; median length of time since diagnosis, 25.0 years) for a cardiac assessment. Of these survivors, 300 (55\%) are at high risk, and 244 (45\%) are at standard risk of cardiac dysfunction. Conclusions: This study will determine the prevalence of preclinical cardiac dysfunction in Swiss childhood cancer survivors, inform whether speckle tracking echocardiography is more sensitive to cardiac dysfunction than conventional echocardiography, and give a detailed picture of risk factors for cardiac dysfunction. The results will help improve primary treatment and follow-up care of children with cancer. Trial Registration: ClinicalTrials.gov NCT03790943; https://clinicaltrials.gov/ct2/show/NCT03790943 International Registered Report Identifier (IRRID): DERR1-10.2196/17724 ",
doi="10.2196/17724",
url="http://www.researchprotocols.org/2020/6/e17724/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32269016"
}


@Article{info:doi/10.2196/14896,
author="Tolstrup, K. L{\ae}rke
and Pappot, Helle
and Bastholt, Lars
and Zwisler, Ann-Dorthe
and Dieperink, B. Karin",
title="Patient-Reported Outcomes During Immunotherapy for Metastatic Melanoma: Mixed Methods Study of Patients' and Clinicians' Experiences",
journal="J Med Internet Res",
year="2020",
month="Apr",
day="9",
volume="22",
number="4",
pages="e14896",
keywords="side effects, adverse events, patient-reported outcomes, PRO-CTCAE, melanoma, eHealth, immunotherapy, patient satisfaction",
keywords="CPIs, interviews",
abstract="Background: The benefits of electronic patient reported outcomes (PRO) questionnaires have been demonstrated in many settings, including in hospitals and patient homes. However, it remains to be investigated how melanoma patients and their treating clinicians experience the electronic self-reporting of side effects and the derived communication. Objective: The primary objective of this study was to examine patients' and clinicians' experiences with an eHealth intervention for weekly monitoring of side effects during treatment with immunotherapy. Methods: An eHealth intervention based on questions from the PRO-Common Terminology Criteria for Adverse Events (CTCAE) library was used and tested in a randomized clinical trial with patients receiving immunotherapy for malignant melanoma and clinicians at a university hospital in Denmark. On a weekly basis, patients reported their symptoms from home during the treatment via a provided tablet. The electronic patient reports were available to clinicians in the outpatient clinic. A mixed methods approach was applied to investigate the patients' and clinicians' experiences with the intervention. Data from patient experiences were collected in a short survey, the Patient Feedback Form. Moreover, a subset of the patients participating in the survey was interviewed about their experience. Furthermore, one focus group interview with clinicians was carried out to elucidate their views. Results: A total of 57 patients completed the Patient Feedback Form, and 14 patients were interviewed. The focus group interview included 5 clinicians. Overall, patients and clinicians were satisfied with the tool. They believed it enhanced patients' awareness of side effects and increased their feeling of involvement. The patients reported that it was easy to fill out the questionnaire and that it made sense to do so. However, a minority of the patients expressed in the interviews that they did not believe that the health care professionals had seen their reports when they came to the clinic, and that the reporting did not lead to increased contact with the department. Conclusions: Overall, satisfaction with the eHealth intervention was high among patients and their treating clinicians. The tool was easy to use and contributed to greater symptom awareness and patient involvement. Thus, in terms of patient and clinician satisfaction with the tool, it makes sense to continue using the tool beyond the project period. Trial Registration: ClinicalTrials.gov NCT03073031; https://tinyurl.com/tjx3gtu ",
doi="10.2196/14896",
url="https://www.jmir.org/2020/4/e14896",
url="http://www.ncbi.nlm.nih.gov/pubmed/32271150"
}


@Article{info:doi/10.2196/16013,
author="Alonso Puig, Mario
and Alonso-Prieto, Mercedes
and Mir{\'o}, Jordi
and Torres-Luna, Raquel
and Plaza L{\'o}pez de Sabando, Diego
and Reinoso-Barbero, Francisco",
title="The Association Between Pain Relief Using Video Games and an Increase in Vagal Tone in Children With Cancer: Analytic Observational Study With a Quasi-Experimental Pre/Posttest Methodology",
journal="J Med Internet Res",
year="2020",
month="Mar",
day="30",
volume="22",
number="3",
pages="e16013",
keywords="hematology oncology",
keywords="pediatric patient",
keywords="acute pain",
keywords="patient-controlled analgesia",
keywords="video pupilometer",
keywords="analgesia nociception index",
abstract="Background: Patients with secondary pain due to mucositis after chemotherapy require treatment with morphine. Use of electronic video games (EVGs) has been shown to be an effective method of analgesia in other clinical settings. Objective: The main objective of this study was to assess the association between the use of EVGs and the intensity of pain caused by chemotherapy-induced mucositis in pediatric patients with cancer. The secondary objective was to assess the association between changes in pain intensity and sympathetic-parasympathetic balance in this sample of pediatric patients. Methods: Clinical records were compared between the day prior to the use of EVGs and the day after the use of EVGs. The variables were variations in pupil size measured using the AlgiScan video pupilometer (IDMed, Marseille, France), heart rate variability measured using the Analgesia Nociception Index (ANI) monitor (Mdoloris Medical Systems, Loos, France), intensity of pain measured using the Numerical Rating Scale (score 0-10), and self-administered morphine pump parameters. Results: Twenty patients (11 girls and nine boys; mean age 11.5 years, SD 4.5 years; mean weight 41.5 kg, SD 20.7 kg) who met all the inclusion criteria were recruited. EVGs were played for a mean of 2.3 (SD 1.3) hours per day, resulting in statistically significant changes. After playing EVGs, there was significantly lower daily morphine use (before vs after playing EVGs: 35.9 vs 28.6 {\textmu}g/kg/day, P=.003), lower demand for additional pain relief medication (17 vs 9.6 boluses in 24 hours, P=.001), lower scores of incidental pain intensity (7.7 vs 5.4, P=.001), lower scores of resting pain (4.8 vs 3.2, P=.01), and higher basal parasympathetic tone as measured using the ANI monitor (61.8 vs 71.9, P=.009). No variation in pupil size was observed with the use of EVGs. Conclusions: The use of EVGs in pediatric patients with chemotherapy-induced mucositis has a considerable analgesic effect, which is associated physiologically with an increase in parasympathetic vagal tone despite lower consumption of morphine. ",
doi="10.2196/16013",
url="http://www.jmir.org/2020/3/e16013/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32224482"
}


@Article{info:doi/10.2196/15969,
author="Spahrk{\"a}s, S. Simon
and Looijmans, Anne
and Sanderman, Robbert
and Hagedoorn, Mari{\"e}t",
title="Beating Cancer-Related Fatigue With the Untire Mobile App: Protocol for a Waiting List Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2020",
month="Feb",
day="14",
volume="9",
number="2",
pages="e15969",
keywords="RCT",
keywords="mHealth",
keywords="app",
keywords="intervention",
keywords="fatigue",
keywords="quality of life",
keywords="cancer patients",
keywords="cancer survivors",
keywords="psycho-oncology",
abstract="Background: Many cancer patients and survivors worldwide experience disabling fatigue as the main side effect of their illness and the treatments involved. Face-to-face therapy is effective in treating cancer-related fatigue (CRF), but it is also resource-intensive. Offering a self-management program via a mobile phone app (ie, the Untire app), based on elements of effective face-to-face treatments, might increase the number of patients receiving adequate support for fatigue and decrease care costs. Objective: The aim of this protocol is to describe a randomized controlled trial (RCT) to assess the effectiveness of the Untire app in reducing fatigue in cancer patients and survivors after 12 weeks of app use as compared with a waiting list control group. Substudies nested within this trial include questions concerning the reach and costs of online recruitment and uptake and usage of the Untire app. Methods: The Untire app study is a waiting list RCT targeting cancer patients and survivors who experience moderate to severe fatigue via social media (Facebook and Instagram) across 4 English-speaking countries (Australia, Canada, the United Kingdom, and the United States). The Untire app includes psychoeducation and exercises concerning energy conservation, activity management, optimizing restful sleep, mindfulness-based stress reduction, psychosocial support, cognitive behavioral therapy, and physical activity. After randomization, participants in the intervention group could access the Untire app immediately, whereas control participants had no access to the Untire app until the primary follow-up assessment at 12 weeks. Participants completed questionnaires at baseline before randomization and after 4, 8, 12, and 24 weeks. The study outcomes are fatigue (primary) and quality of life (QoL; secondary). Potential moderators and mediators of the hypothesized treatment effect on levels of fatigue and QoL were also assessed. Link clicks and app activation are used to assess reach and uptake, respectively. Log data are used to explore the characteristics of app use. Sample size calculations for the primary outcome showed that we needed to include 164 participants with complete 12-week measures both in the intervention and the control groups. The intention-to-treat approach is used in the primary analyses, which refers to analyzing all participants regardless of their app use. Results: Participants were recruited from March to October 2018. The last participant completed the 24-week assessment in March 2019. Conclusions: This mobile health (mHealth) RCT recruited participants online in multiple countries to examine the uptake and effectiveness of the Untire self-management app to reduce CRF. Many advantages of mHealth apps are assumed, such as the immediate access to the app, the low thresholds to seek support, and the absence of contact with care professionals that will reduce costs. If found effective, this app can easily be offered worldwide to patients experiencing CRF. Trial Registration: Netherlands Trial Register NL6642; https://www.trialregister.nl/trial/6642. International Registered Report Identifier (IRRID): DERR1-10.2196/15969 ",
doi="10.2196/15969",
url="http://www.researchprotocols.org/2020/2/e15969/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32130185"
}


@Article{info:doi/10.2196/13217,
author="Bao, Ting
and Deng, Gary
and DeMarzo, A. Lauren
and Zhi, Iris W.
and DeRito, L. Janice
and Blinder, Victoria
and Chen, Connie
and Li, S. Qing
and Green, Jamie
and Pendleton, Eva
and Mao, J. Jun",
title="A Technology-Assisted, Brief Mind-Body Intervention to Improve the Waiting Room Experience for Chemotherapy Patients: Randomized Quality Improvement Study",
journal="JMIR Cancer",
year="2019",
month="Nov",
day="7",
volume="5",
number="2",
pages="e13217",
keywords="mobile app",
keywords="acupressure",
keywords="meditation",
keywords="symptom relief",
keywords="chemotherapy",
abstract="Background: Patients waiting for chemotherapy can experience stress, anxiety, nausea, and pain. Acupressure and meditation have been shown to control such symptoms. Objective: This study aimed to evaluate the feasibility and effectiveness of an integrative medicine app to educate patients about these self-care tools in chemotherapy waiting rooms. Methods: We screened and enrolled cancer patients in chemotherapy waiting rooms at two Memorial Sloan Kettering Cancer Center locations. Patients were randomly assigned into an intervention arm in which subjects watched acupressure and meditation instructional videos or a control arm in which they watched a time- and attention-matched integrative oncology lecture video. Before and after watching the videos, we asked the patients to rate four key symptoms: stress, anxiety, nausea, and pain. We performed the analysis of covariance to detect differences between the two arms postintervention while controlling for baseline symptoms. Results: A total of 223 patients were enrolled in the study: 113 patients were enrolled in the intervention arm and 110 patients were enrolled in the control arm. In both groups, patients showed significant reductions in stress and anxiety from baseline (all P<.05), with the treatment arm reporting greater stress and anxiety reduction than the control arm (1.64 vs 1.15 in stress reduction; P=.01 and 1.39 vs 0.78 in anxiety reduction; P=.002). The majority of patients reported that the videos helped them pass time and that they would watch the videos again. Conclusions: An integrative medicine self-care app in the waiting room improved patients' experiences and reduced anxiety and stress. Future research could focus on expanding this platform to other settings to improve patients' overall treatment experiences. ",
doi="10.2196/13217",
url="http://cancer.jmir.org/2019/2/e13217/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31697238"
}


@Article{info:doi/10.2196/14418,
author="Ariza-Garcia, Angelica
and Lozano-Lozano, Mario
and Galiano-Castillo, Noelia
and Postigo-Martin, Paula
and Arroyo-Morales, Manuel
and Cantarero-Villanueva, Irene",
title="A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2019",
month="Jul",
day="24",
volume="21",
number="7",
pages="e14418",
keywords="breast cancer",
keywords="chemotherapy",
keywords="physical fitness",
keywords="randomized control trial",
keywords="telehealth",
keywords="e-health",
keywords="therapeutic exercise",
abstract="Background: Breast cancer patients have to face a high-risk state during chemotherapy, which involves deterioration of their health including extensive physical deterioration. Face-to-face physical exercise programs have presented low adherence rates during medical treatment, and telehealth systems could improve these adherence rates. Objective: This study aimed to evaluate the effectiveness of a Web-based exercise program (e-CuidateChemo) to mitigate the side effects of chemotherapy on the physical being, anthropometric aspects, and body composition. Methods: A total of 68 patients diagnosed with breast cancer, who were undergoing chemotherapy, were enrolled. The patients were categorized into two groups: e-CuidateChemo (n=34) and controls (n=34). The e-CuidateChemo group participated in an adapted 8-week tailored exercise program through a Web-based system. A blinded, trained researcher assessed functional capacity, strength, anthropometric parameters, and body composition. The intervention effects were tested using analysis of covariance and Cohen d tests. Results: Functional capacity improved significantly in the e-CuidateChemo group compared to the control group (6-minute walk test: 62.07 [SD 130.09] m versus --26.34 [SD 82.21] m; 6-minute walk test \% distance predicted: 10.81\% [SD 22.69\%] m versus --4.60\% [SD 14.58\%]; between-group effect: P=.015 for both). The intervention group also showed significantly improved secondary outcomes such as between-group effects for abdominal (24.93 [SD 26.83] s vs --18.59 [SD 38.69] s), back (12.45 [SD 10.20] kg vs 1.39 [10.72] kg), and lower body (--2.82 [SD 3.75] s vs 1.26 [SD 2.84] s) strength; all P<.001 compared to the control group. Conclusions: This paper showed that a Web-based exercise program was effective in reversing the detriment in functional capacity and strength due to chemotherapy. Trial Registration: ClinicalTrials.gov NCT02350582; https://clinicaltrials.gov/ct2/show/NCT02350582 ",
doi="10.2196/14418",
url="http://www.jmir.org/2019/7/e14418/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31342907"
}


@Article{info:doi/10.2196/12453,
author="Labrie, Nanon
and van Dulmen, Sandra
and Kersten, Jos{\'e} Marie
and de Haes, JCM Hanneke
and Pieterse, H. Arwen
and van Weert, CM Julia
and van Spronsen, Johan Dick
and Smets, MA Ellen
and ",
title="Effective Information Provision About the Side Effects of Treatment for Malignant Lymphoma: Protocol of a Randomized Controlled Trial Using Video Vignettes",
journal="JMIR Res Protoc",
year="2019",
month="May",
day="2",
volume="8",
number="5",
pages="e12453",
keywords="physician patient relationship",
keywords="health communication",
keywords="information dissemination",
keywords="immediate recall",
keywords="trust",
keywords="symptoms",
keywords="clinical trial protocol",
keywords="video vignettes",
abstract="Background: Informing patients with cancer about the possible implications of prospective treatment is a crucial yet challenging task. Unfortunately, patients' recall of medical information is generally poor and their information needs are not met. Effective information giving entails that oncologists help patients understand and recall the implications of their treatment, meanwhile fostering a trusting physician-patient relationship. Communication strategies that are often suggested to be effective are structuring and tailoring (cognition-oriented) but also are oncologists' expressions of caring or empathy (affect-oriented). Objective: The aim of this study is to provide evidence concerning the pathways linking physician communication to (improved) consultation outcomes for patients. More specifically, the aim is to determine the effects of information structuring and information tailoring, combined with physician caring, on information recall, satisfaction with information, and trust in the physician (primary objective) and on symptom distress (secondary objective). Methods: A randomized controlled trial, systematically testing the effects of information structuring and information tailoring, each combined with caring, in 2 video-vignette experiments (2{\texttimes}2 and 2{\texttimes}2{\texttimes}2 design). Using an online survey platform, participants will be randomly allocated (blinded) to 1 of 12 conditions in which they are asked to view a video vignette (intervention) in which an oncologist discusses a treatment plan for malignant lymphoma with a patient. The independent variables of interest are systematically varied across conditions. The outcome measures are assessed in a survey, using validated instruments. Study participants are (former) patients with cancer and their relatives recruited via online panels and patient organizations. This protocol discusses the trial design, including the video-vignette design, intervention pretesting, and a pilot study. Results: Data collection has now been completed, and preliminary analyses will be available in Spring 2019. A total of 470 participants completed the first part of the survey and were randomized to receive the intervention. Conclusions: The results of the proposed trial will provide evidence concerning the pathways linking physician information, giving skills to (improved) consultation outcomes for patients. Trial Registration: Netherlands Trial Register NTR6153; https://www.trialregister.nl/trial/6022 (Archived by Webcite at http://www.webcitation.org/76xVV9xC8). International Registered Report Identifier (IRRID): DERR1-10.2196/12453 ",
doi="10.2196/12453",
url="http://www.researchprotocols.org/2019/5/e12453/"
}


@Article{info:doi/10.2196/jmir.9958,
author="Prince, M. Rebecca
and Soung Yee, Anthony
and Parente, Laura
and Enright, A. Katherine
and Grunfeld, Eva
and Powis, Melanie
and Husain, Amna
and Gandhi, Sonal
and Krzyzanowska, K. Monika",
title="User-Centered Design of a Web-Based Tool to Support Management of Chemotherapy-Related Toxicities in Cancer Patients",
journal="J Med Internet Res",
year="2019",
month="Mar",
day="28",
volume="21",
number="3",
pages="e9958",
keywords="prototype",
keywords="Web-based tool",
keywords="toxicity management",
keywords="chemotherapy",
keywords="self-management",
abstract="Background: Cancer patients receiving chemotherapy have high symptom needs that can negatively impact quality of life and result in high rates of unplanned acute care visits. Remote monitoring tools may improve symptom management in this patient population. Objective: This study aimed to design a prototype tool to facilitate remote management of chemotherapy-related toxicities. Methods: User needs were assessed using a participatory, user-centered design methodology that included field observation, interviews, and focus groups, and then analyzed using affinity diagramming. Participants included oncology patients, caregivers, and health care providers (HCPs) including medical oncologists, oncology nurses, primary care physicians, and pharmacists in Ontario, Canada. Overarching themes informed development of a Web-based prototype, which was further refined over 2 rounds of usability testing with end users. Results: Overarching themes were derived from needs assessments, which included 14 patients, 1 caregiver, and 12 HCPs. Themes common to both patients and HCPs included gaps and barriers in current systems, need for decision aids, improved communication and options in care delivery, secure access to credible and timely information, and integration into existing systems. In addition, patients identified missed opportunities, care not meeting their needs, feeling overwhelmed and anxious, and wanting to be more empowered. HCPs identified accountability for patient management as an issue. These themes informed development of a Web-based prototype (bridges), which included toxicity tracking, self-management advice, and HCP communication functionalities. Usability testing with 11 patients and 11 HCPs was generally positive; however, identified challenges included tool integration into existing workflows, need for standardized toxicity self-management advice, issues of privacy and consent, and patient-tailored information. Conclusions: Web-based tools integrating just-in-time self-management advice and HCP support into routine care may address gaps in systems for managing chemotherapy-related toxicities. Attention to the integration of new electronic tools into self-care by patients and practice was a strong theme for both patients and HCP participants and is a key issue that needs to be addressed for wide-scale adoption. ",
doi="10.2196/jmir.9958",
url="http://www.jmir.org/2019/3/e9958/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30920373"
}


@Article{info:doi/10.2196/10883,
author="Pearson, E. Stephanie
and Taylor, John
and Hoare, J. Derek
and Patel, Poulam
and Baguley, M. David",
title="Exploring the Experiences of Cancer Patients With Chemotherapy-Induced Ototoxicity: Qualitative Study Using Online Health Care Forums",
journal="JMIR Cancer",
year="2019",
month="Mar",
day="14",
volume="5",
number="1",
pages="e10883",
keywords="quality of life",
keywords="neoplasms",
keywords="drug-related side effects and adverse reactions",
keywords="hearing loss",
keywords="tinnitus",
keywords="online social networking",
keywords="internet",
keywords="eHealth",
keywords="social support",
abstract="Background: Many cancer patients and survivors experience permanent and life-debilitating effects, such as ototoxicity, from treatment. Ototoxicity manifests as high-frequency hearing loss and tinnitus, which can have a detrimental effect on the quality of life (QoL) of those affected. Currently, there is little information and support offered to these patients who experience ototoxicity, potentially leading to many being undiagnosed and untreated. Objective: The aim of this study was to explore the extent of ototoxic side effects, such as hearing loss and tinnitus, and their impact on cancer patients following chemotherapy treatment. Secondary objectives included detecting the time periods of onset and duration of the ototoxicity and identifying what support was available to this population. Methods: Posts from publicly available online forums were thematically analyzed using the guidelines by Braun and Clarke. A coding manual was iteratively developed to create a framework for the analysis of the ototoxicity experience among the cancer population. Results: A total of 9 relevant online forums were identified, consisting of 86 threads and 570 posts from 377 members. Following the bottom-up thematic analysis, 6 major themes were identified: nature of ototoxicity, time of experienced ototoxicity, information on ototoxicity, quality of life, therapies, and online social support. Conclusions: There was a significant number of reports expressing concerns about the lack of information on the risk of ototoxicity. More support for those suffering is needed; for example, improved interdepartmental communication between oncology and audiology services could optimize patient care. Patients should also be encouraged to communicate with their health care professionals about their ototoxicity and relay how their QoL is impacted by ototoxicity when accessing support. Tinnitus was the most common concern and was associated with distress. Hearing loss was less common; however, it was associated with fear and employment issues. Those who reported preexisting conditions were fearful about worsening their condition as their QoL was already impacted. ",
doi="10.2196/10883",
url="http://cancer.jmir.org/2019/1/e10883/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30869640"
}