@Article{info:doi/10.2196/69398, author="Hubel, J. Niclas and Vorbach, M. Samuel and de Ligt, M. Kelly and Rathgeber, S. Ines and Beyer, Katharina and Wintner, M. Lisa and Faller, Barbara and Nemec, Jasmin and Holzner, Bernhard and Sztankay, Monika and Lehmann, Jens", title="Sustainability and Time Trends in Electronic Patient-Reported Outcome Assessment in Routine Cancer Care: Systematic Scoping Review and Follow-Up Survey", journal="J Med Internet Res", year="2025", month="Apr", day="25", volume="27", pages="e69398", keywords="patient-reported outcome measures", keywords="cancer, clinical routine", keywords="health-related quality of life", keywords="quality of care", keywords="mobile applications", keywords="digital technology", abstract="Background: Routine electronic assessment of patient-reported outcomes (ePROs) can improve cancer care; yet, its implementation in routine practice and long-term sustainability remain unclear. Understanding these aspects is critical to advancing the field. Objective: To review and describe the past and current status, time trends, and long-term sustainability of clinical ePRO applications in routine oncology care. Methods: We conducted a systematic review of publications on ePRO use in oncology care up to December 31, 2023, searching PubMed and Web of Science and extracting data on clinical ePRO applications. We included peer-reviewed studies including patients with cancer using ePRO assessments in clinical practice, excluding research letters and conference abstracts. Data from the review were analyzed using descriptive statistics and univariate regression models to evaluate time trends, with year of publication as the predictor. A follow-up survey was sent to authors of published ePRO applications to assess their current use of the application or reasons for discontinuation. Responses from the follow-up survey were analyzed descriptively. Results: For the review, we screened 2933 references, and 303 met inclusion criteria. Results showed that Europe was the most common region (n=141, 46.5\%), and study populations consisted mostly of adult patients (n=276, 91.1\%) under chemotherapy treatment (n=124, 40.9\%) assessed in an outpatient setting (n=261, 86.1\%). The EORTC (European Organisation for Research and Treatment of Cancer; n=77, 25.4\%) and PRO-CTCAE (Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events) questionnaires (n=65, 21.5\%) were most frequently integrated into ePRO applications. In the univariate analysis, we found that publications increased significantly over time (2003-2023, P<.001). Trends showed a rise in mobile app use (odds ratio [OR] 1.211, P<.001), remote assessments (OR 1.094, P=.002), and feedback provided to patients (OR 1.060, P=.04). Of the 303 studies, 221 unique clinical ePRO applications were identified, merging publications at the application level. The follow-up survey had a 35.3\% response rate (78/221), with 61.1\% of ePRO applications still in use, lasting a median of 5 years. The most common reason for discontinuation was a lack of funding and resources (42.9\%, 12/28). Conclusions: The field of ePRO assessment in oncology is rapidly evolving, with a shift toward remote, app-based tools and a growing emphasis on providing feedback to patients. We present, for the first time, data on the sustainability of ePRO use in routine care. While our findings offer valuable insights, they should be interpreted in light of potential response bias in the follow-up survey. Several ePRO applications remain in active use, highlighting potential for long-term integration into clinical practice. However, financial constraints, limited reimbursement models, and challenges with workflow integration continue to hinder broader and more sustainable adoption. Addressing these barriers will be essential to support the continued use of ePROs in clinical care. ", doi="10.2196/69398", url="https://www.jmir.org/2025/1/e69398" } @Article{info:doi/10.2196/57782, author="Lambert, Aur{\'e}lien and Hombourger, Benoit and Salleron, Julia and Chergui, Fadila and Vallance, Catherine and Nicolas, Nad{\`e}ge and Moussouni, Marie and Cherif, Lounisse and Chenot, Emile and Gavoille, C{\'e}line and Massard, Vincent", title="Impact of Electronic Transition and Prefilled Templates on Drug Prescription Compliance: Retrospective Study", journal="J Med Internet Res", year="2025", month="Apr", day="9", volume="27", pages="e57782", keywords="drug prescription", keywords="electronic prescription", keywords="handwriting", keywords="medical oncology", keywords="ambulatory care", abstract="Background: The transition from traditional handwritten prescriptions to electronic prescribing systems represents a significant advancement, with the potential to enhance treatment efficacy, patient safety, and professional communication. Objective: This study aimed to examine the impact of this transition within a medical oncology service, assessing the compliance of electronic prescriptions with established good practice standards and exploring the associated risks. Methods: In this retrospective analysis, we compared handwritten prescriptions from the pre-electronic era (January to May 2018) with electronic prescriptions (January to May 2021) following the implementation of the electronic prescribing system PandaLab Pro (PandaLab SAS). The inclusion criteria focused on outpatient oncology treatments, with a clear set of exclusion parameters to ensure a focused study scope. We defined good compliance as the written mention of the evaluated terms. The compliance rates were then compared using a chi-square test. Results: Our findings, based on a sample size of 260 prescriptions (randomized among 30,526 archived prescriptions), indicate a substantial improvement in electronic prescriptions' compliance with prescribers and patient details, treatment accuracy, and overall adherence to regulatory standards. Notably, electronic formats achieved a remarkable 80.8\% accuracy rate in compliance with safety criteria compared with 8.5\% for handwritten prescriptions (P<.001). The use of prefilled prescriptions significantly increased compliance from a safety perspective (56\% vs 96.2\%; P<.001) compared with electronic prescriptions from scratch. Conclusions: The analysis further underscores the advantages of prefilled electronic prescription templates, which significantly improved compliance rates compared with manually filled electronic and handwritten prescriptions. Furthermore, the study revealed a marked shift in prescribing behaviors, with electronic prescriptions tending to be more concise yet more numerous, suggesting an impact on medication management and patient adherence, which warrants further investigation. The study supports the transition to electronic prescribing systems in oncology, highlighting enhanced traceability, compliance with health authority standards, and patient safety. The implementation of prefilled templates supported by pharmacists has emerged as a pivotal factor in this improved process. While acknowledging certain limitations, such as the nonquantitative assessment of time savings and acceptability, this research advocates for the widespread adoption of electronic prescriptions and serves as a benchmark for future e-prescription initiatives in France. ", doi="10.2196/57782", url="https://www.jmir.org/2025/1/e57782", url="http://www.ncbi.nlm.nih.gov/pubmed/40202779" } @Article{info:doi/10.2196/59298, author="Spotnitz, Matthew and Giannini, John and Ostchega, Yechiam and Goff, L. Stephanie and Anandan, Priya Lakshmi and Clark, Emily and Litwin, R. Tamara and Berman, Lew", title="Assessing the Data Quality Dimensions of Partial and Complete Mastectomy Cohorts in the All of Us Research Program: Cross-Sectional Study", journal="JMIR Cancer", year="2025", month="Mar", day="11", volume="11", pages="e59298", keywords="data quality", keywords="electronic health record", keywords="breast cancer", keywords="breast-conserving surgery", keywords="total mastectomy", keywords="modified radical mastectomy", keywords="public health informatics", keywords="cohort", keywords="assessment", keywords="women", keywords="United States", keywords="American", keywords="nonmetastatic disease", keywords="treatment", keywords="breast cancer surgery", keywords="real-world evidence", keywords="data", keywords="mastectomy", keywords="female", keywords="data quality framework", keywords="therapy", abstract="Background: Breast cancer is prevalent among females in the United States. Nonmetastatic disease is treated by partial or complete mastectomy procedures. However, the rates of those procedures vary across practices. Generating real-world evidence on breast cancer surgery could lead to improved and consistent practices. We investigated the quality of data from the All of Us Research Program, which is a precision medicine initiative that collected real-world electronic health care data from different sites in the United States both retrospectively and prospectively to participant enrollment. Objective: The paper aims to determine whether All of Us data are fit for use in generating real-world evidence on mastectomy procedures. Methods: Our mastectomy phenotype consisted of adult female participants who had CPT4 (Current Procedural Terminology 4), ICD-9 (International Classification of Diseases, Ninth Revision) procedure, or SNOMED (Systematized Nomenclature of Medicine) codes for a partial or complete mastectomy procedure that mapped to Observational Medical Outcomes Partnership Common Data Model concepts. We evaluated the phenotype with a data quality dimensions (DQD) framework that consisted of 5 elements: conformance, completeness, concordance, plausibility, and temporality. Also, we applied a previously developed DQD checklist to evaluate concept selection, internal verification, and external validation for each dimension. We compared the DQD of our cohort to a control group of adult women who did not have a mastectomy procedure. Our subgroup analysis compared partial to complete mastectomy procedure phenotypes. Results: There were 4175 female participants aged 18 years or older in the partial or complete mastectomy cohort, and 168,226 participants in the control cohort. The geospatial distribution of our cohort varied across states. For example, our cohort consisted of 835 (20\%) participants from Massachusetts, but multiple other states contributed fewer than 20 participants. We compared the sociodemographic characteristics of the partial (n=2607) and complete (n=1568) mastectomy subgroups. Those groups differed in the distribution of age at procedure (P<.001), education (P=.02), and income (P=.03) levels, as per $\chi$2 analysis. A total of 367 (9.9\%) participants in our cohort had overlapping CPT4 and SNOMED codes for a mastectomy, and 63 (1.5\%) had overlapping ICD-9 procedure and SNOMED codes. The prevalence of breast cancer--related concepts was higher in our cohort compared to the control group (P<.001). In both the partial and complete mastectomy subgroups, the correlations among concepts were consistent with the clinical management of breast cancer. The median time between biopsy and mastectomy was 5.5 (IQR 3.5-11.2) weeks. Although we did not have external benchmark comparisons, we were able to evaluate concept selection and internal verification for all domains. Conclusions: Our data quality framework was implemented successfully on a mastectomy phenotype. Our systematic approach identified data missingness. Moreover, the framework allowed us to differentiate breast-conserving therapy and complete mastectomy subgroups in the All of Us data. ", doi="10.2196/59298", url="https://cancer.jmir.org/2025/1/e59298" } @Article{info:doi/10.2196/65118, 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="Treatment Outcomes From Erlotinib and Gefitinib in Advanced Epidermal Growth Factor Receptor--Mutated Nonsquamous Non--Small Cell Lung Cancer in Aotearoa New Zealand From 2010 to 2020: Nationwide Whole-of-Patient-Population Retrospective Cohort Study", journal="JMIR Cancer", year="2025", month="Mar", day="3", volume="11", pages="e65118", keywords="non--small cell lung cancer", keywords="mutations", keywords="epidemiology", keywords="target therapy", keywords="retrospective cohort study", abstract="Background: Health care system--wide outcomes from routine treatment with erlotinib and gefitinib are incompletely understood. Objective: The aim of the study is to describe the effectiveness of erlotinib and gefitinib during the first decade of their routine use for treating advanced epidermal growth factor receptor (EGFR) mutation-positive nonsquamous non--small cell lung cancer in the entire cohort of patients treated in Aotearoa New Zealand. Methods: Patients were identified, and data collated from national pharmaceutical dispensing, cancer registration, and mortality registration electronic databases by deterministic data linkage using National Health Index numbers. Time-to-treatment discontinuation and overall survival were measured from the date of first dispensing of erlotinib or gefitinib and analyzed by Kaplan-Meier curves. Associations of treatment outcomes with baseline factors were evaluated using univariable and multivariable Cox regressions. Results: Overall, 752 patients were included who started treatment with erlotinib (n=418) or gefitinib (n=334) before October 2020. Median time-to-treatment discontinuation was 11.6 (95\% CI 10.8?12.4) months, and median overall survival was 20.1 (95\% CI 18.1?21.6) months. Shorter time-to-treatment discontinuation was independently associated with high socioeconomic deprivation (hazard ratio [HR] 1.3, 95\% CI 1.1?1.5 compared to the New Zealand Index of Deprivation 1?4 group), EGFR L858R mutations (HR 1.3, 95\% CI 1.1?1.6 compared to exon 19 deletion), and distant disease at cancer diagnosis (HR 1.4, 95\% CI 1.2?1.7 compared to localized or regional disease). The same factors were independently associated with shorter overall survival. Outcome estimates and predictors remained unchanged in sensitivity analyses. Conclusions: Outcomes from routine treatment with erlotinib and gefitinib in New Zealand patients with advanced EGFR-mutant nonsquamous non--small cell lung cancer are comparable with those reported in randomized trials and other health care system--wide retrospective cohort studies. Socioeconomic status, EGFR mutation subtype, and disease extent at cancer diagnosis were independent predictors of treatment outcomes in that setting. Trial Registration: Australia New Zealand Clinical Trials Registry ACTRN12615000998549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368928\&isReview=true International Registered Report Identifier (IRRID): RR2-10.2196/51381 ", doi="10.2196/65118", url="https://cancer.jmir.org/2025/1/e65118" } @Article{info:doi/10.2196/65148, author="Scruton, Sarah and Wong, Geoff and Babinski, Stephanie and Squires, R. Lauren and Berlin, Alejandro and Easley, Julie and McGee, Sharon and Noel, Ken and Rodin, Danielle and Sussman, Jonathan and Urquhart, Robin and Bender, L. Jacqueline", title="Optimizing Virtual Follow-Up Care: Realist Evaluation of Experiences and Perspectives of Patients With Breast and Prostate Cancer", journal="J Med Internet Res", year="2025", month="Jan", day="3", volume="27", pages="e65148", keywords="cancer", keywords="follow-up", keywords="virtual", keywords="outcomes", keywords="realist evaluation", keywords="survivorship", abstract="Background: Virtual follow-up (VFU) has the potential to enhance cancer survivorship care. However, a greater understanding is needed of how VFU can be optimized. Objective: This study aims to examine how, for whom, and in what contexts VFU works for cancer survivorship care. Methods: We conducted a realist evaluation of VFU among patients with breast cancer and prostate cancer at an urban cancer center during the COVID-19 pandemic. Realist evaluations examine how underlying causal processes of an intervention (mechanisms) in specific circumstances (contexts) interact to produce results (outcomes). Semistructured interviews were conducted with a purposive sample of patients ?5 years after diagnosis. Interviews were audio-recorded and analyzed using a realist logic of analysis. Results: Participants (N=24; n=12, 50\% with breast cancer and n=12, 50\% with prostate cancer) had an average age of 59.6 (SD 10.7) years. Most participants (20/24, 83\%) were satisfied with VFU and wanted VFU options to continue after the COVID-19 pandemic. However, VFU impacted patient perceptions of the quality of their care, particularly in terms of its effectiveness and patient centeredness. Whether VFU worked well for patients depended on patient factors (eg, needs, psychosocial well-being, and technological competence), care provider factors (eg, socioemotional behaviors and technological competence), and virtual care system factors (eg, modality, functionality, usability, virtual process of care, and communication workflows). Key mechanisms that interacted with contexts to produce positive outcomes (eg, satisfaction) were visual cues, effective and empathetic communication, and a trusting relationship with their provider. Conclusions: Patients value VFU; however, VFU is not working as well as it could for patients. To optimize VFU, it is critical to consider contexts and mechanisms that impact patient perceptions of the patient centeredness and effectiveness of their care. Offering patients the choice of in-person, telephone, or video visits when possible, coupled with streamlined access to in-person care when required, is important. Prioritizing and addressing patient needs; enhancing physician virtual socioemotional behaviors and technology competency; and enhancing VFU functionality, usability, and processes of care and communication workflows will improve patient perceptions of the patient centeredness and effectiveness of virtual care. ", doi="10.2196/65148", url="https://www.jmir.org/2025/1/e65148" } @Article{info:doi/10.2196/55746, author="Kamminga, Willemina Nadia Christina and Lugtenberg, Marjolein and Van den Broek, Annabel Julia and Nijsten, Tamar and Wakkee, Marlies and Tabeau, Kasia", title="Exploring Motives Behind Ideal Melanoma Survivorship Care Plans With Multiple Stakeholders: A Cocreation Study", journal="JMIR Cancer", year="2025", month="Jan", day="2", volume="11", pages="e55746", keywords="cocreation", keywords="survivorship care", keywords="psycho-oncology", keywords="supportive care", keywords="motives", keywords="melanoma", keywords="cancer survivor", keywords="melanoma care", abstract="Background: Survivorship care plans (SCPs), ie, personalized health care plans for cancer survivors, can be used to support the growing group of melanoma survivors throughout their disease trajectory. However, implementation and effectiveness of SCPs are suboptimal and could benefit from the involvement of stakeholders in developing a user-centered design. Objective: The aim of this study was to identify the ideal SCP for patients with melanoma in terms of functions and features to be included according to different stakeholders and to explore their underlying motives. Methods: In total, 3 cocreation sessions were organized with mixed samples of stakeholders, ie, patients with (a history of) melanoma (n=4), health care providers (HCPs) active in melanoma care (n=3), and IT specialists active in hospital IT departments (n=6). They were invited to compose their ideal melanoma SCP based on potential functions and features identified from prior qualitative research. These functions and features belonged to one of the four main categories of survivorship care (SSC): (1) information and education, (2) identification and treatment, (3) oncological follow-up, and (4) coordination. Participants were invited to explain their motives for including functions and features. Ideas were shared between stakeholders, and interaction was promoted. Descriptive statistics were used to determine the ideal SCP per stakeholder group. To analyze underlying motives, all cocreation sessions were audio-taped, transcribed verbatim, and analyzed in a thematic content analysis. Results: With regard to their ideal SCPs, all stakeholders added functions from all 4 SSC categories. Patients assembled a rather compact SCP with category 2 on identification and treatment being most important. Both HCPs and IT professionals constructed a somewhat larger SCP, with category 3 on oncological follow-up being the most important aspect and HCPs also focusing on category 4 on coordination. As for the motives behind their ideal SCP compositions, patients predominantly added functions based on their personal experiences or experiences from fellow patients, whereas both HCPS and IT professionals based their compositions primarily on their respective areas of expertise: HCPs related their additions to their roles as medical practitioners; for example, in providing a complete treatment plan and obtaining informed consent, while IT professionals' contributions were mainly influenced by feasibility and privacy concerns. Conclusions: This cocreation study provides insights into stakeholders' ideal melanoma SCP and the motivations behind them. Considering the diversity in both the preferences and underlying motives regarding SCP composition between patients, HCPs, and IT specialists, it is crucial to develop a broad SCP that extends beyond traditional SCP content, emphasizing personalization. In addition to continued stakeholder involvement, efforts should be focused on addressing potential feasibility and privacy issues to ensure the SCP meets both patients' and HCPs' needs. ", doi="10.2196/55746", url="https://cancer.jmir.org/2025/1/e55746" } @Article{info:doi/10.2196/64243, author="Vives, Nuria and Binefa, Gemma and Travier, Noemie and Farre, Albert and Panera, Aritz Jon and Casas, Berta and Vidal, Carmen and Ib{\'a}{\~n}ez-Sanz, Gemma and Garcia, Montse and ", title="Text Messaging Versus Postal Reminders to Improve Participation in a Colorectal Cancer Screening Program: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2025", month="Jan", day="1", volume="13", pages="e64243", keywords="text message", keywords="mobile health", keywords="colorectal cancer", keywords="screening", keywords="participation", keywords="reminders", keywords="text messaging", keywords="colorectal cancer screening", keywords="fecal immunochemical test", abstract="Background: Mobile phone SMS text message reminders have shown moderate effects in improving participation rates in ongoing colorectal cancer screening programs. Objective: This study aimed to assess the effectiveness of SMS text messages as a replacement for routine postal reminders in a fecal immunochemical test--based colorectal cancer screening program in Catalonia, Spain. Methods: We conducted a randomized controlled trial among individuals aged 50 to 69 years who were invited to screening but had not completed their fecal immunochemical test within 6 weeks. The intervention group (n=12,167) received an SMS text message reminder, while the control group (n=12,221) followed the standard procedure of receiving a reminder letter. The primary outcome was participation within 18 weeks of the invitation. The trial was stopped early, and a recovery strategy was implemented for nonparticipants in the intervention group. We performed a final analysis to evaluate the impact of the recovery strategy on the main outcome of the trial. Participation was assessed using a logistic regression model adjusting for potential confounders (sex, age, and deprivation score index) globally and by screening behavior. Results: The trial was discontinued early in September 2022 due to the results of the interim analysis. The interim analysis included 5570 individuals who had completed 18 weeks of follow-up (intention-to-treat). The SMS text message group had a participation rate of 17.2\% (477/2781), whereas the control group had a participation rate of 21.9\% (610/2789; odds ratio 0.71, 95\% CI 0.62-0.82; P<.001). As a recovery strategy, 7591 (72.7\%) out of 10,442 nonparticipants in the SMS text message group had an open screening episode and received a second reminder by letter, reaching a participation rate of 23\% (1748/7591). The final analysis (N=24,388) showed a participation rate of 29.3\% (3561/12,167) in the intervention group, which received 2 reminders, while the participation rate was 26.5\% (3235/12,221) in the control group (odds ratio 1.16, 95\% CI 1.09-1.23; P<.001). Conclusions: Replacing SMS text messages with reminder letters did not increase the participation rate but also led to a decline in participation among nonparticipants 6 weeks after the invitation. However, sending a second reminder by letter significantly increased participation rates among nonparticipants within 6 weeks in the SMS text message group compared with those who received 1 postal reminder (control group). Additional research is essential to determine the best timing and frequency of reminders to boost participation without being intrusive in their choice of participation. Trial Registration: ClinicalTrials.gov NCT04343950; https://www.clinicaltrials.gov/study/NCT04343950 ", doi="10.2196/64243", url="https://mhealth.jmir.org/2025/1/e64243" } @Article{info:doi/10.2196/63289, author="Carbunaru, Samuel and Neshatvar, Yassamin and Do, Hyungrok and Murray, Katie and Ranganath, Rajesh and Nayan, Madhur", title="Survival After Radical Cystectomy for Bladder Cancer: Development of a Fair Machine Learning Model", journal="JMIR Med Inform", year="2024", month="Dec", day="13", volume="12", pages="e63289", keywords="machine learning", keywords="bladder cancer", keywords="survival", keywords="prediction", keywords="model", keywords="bias", keywords="fairness", keywords="radical cystectomy", keywords="mortality rate", keywords="algorithmic fairness", keywords="health equity", keywords="healthcare disparities", abstract="Background: Prediction models based on machine learning (ML) methods are being increasingly developed and adopted in health care. However, these models may be prone to bias and considered unfair if they demonstrate variable performance in population subgroups. An unfair model is of particular concern in bladder cancer, where disparities have been identified in sex and racial subgroups. Objective: This study aims (1) to develop a ML model to predict survival after radical cystectomy for bladder cancer and evaluate for potential model bias in sex and racial subgroups; and (2) to compare algorithm unfairness mitigation techniques to improve model fairness. Methods: We trained and compared various ML classification algorithms to predict 5-year survival after radical cystectomy using the National Cancer Database. The primary model performance metric was the F1-score. The primary metric for model fairness was the equalized odds ratio (eOR). We compared 3 algorithm unfairness mitigation techniques to improve eOR. Results: We identified 16,481 patients; 23.1\% (n=3800) were female, and 91.5\% (n=15,080) were ``White,'' 5\% (n=832) were ``Black,'' 2.3\% (n=373) were ``Hispanic,'' and 1.2\% (n=196) were ``Asian.'' The 5-year mortality rate was 75\% (n=12,290). The best naive model was extreme gradient boosting (XGBoost), which had an F1-score of 0.860 and eOR of 0.619. All unfairness mitigation techniques increased the eOR, with correlation remover showing the highest increase and resulting in a final eOR of 0.750. This mitigated model had F1-scores of 0.86, 0.904, and 0.824 in the full, Black male, and Asian female test sets, respectively. Conclusions: The ML model predicting survival after radical cystectomy exhibited bias across sex and racial subgroups. By using algorithm unfairness mitigation techniques, we improved algorithmic fairness as measured by the eOR. Our study highlights the role of not only evaluating for model bias but also actively mitigating such disparities to ensure equitable health care delivery. We also deployed the first web-based fair ML model for predicting survival after radical cystectomy. ", doi="10.2196/63289", url="https://medinform.jmir.org/2024/1/e63289" } @Article{info:doi/10.2196/57199, 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/10.2196/59061, author="Zhu, Siying and Dong, Yan and Li, Yumei and Wang, Hong and Jiang, Xue and Guo, Mingen and Fan, Tiantian and Song, Yalan and Zhou, Ying and Han, Yuan", title="Experiences of Patients With Cancer Using Electronic Symptom Management Systems: Qualitative Systematic Review and Meta-Synthesis", journal="J Med Internet Res", year="2024", month="Oct", day="28", volume="26", pages="e59061", keywords="electronic symptom management systems", keywords="oncology care", keywords="access to care", keywords="symptom monitoring", keywords="self-management", keywords="patient-reported outcomes", keywords="health-related outcomes", keywords="quality of life", abstract="Background: There are numerous symptoms related to cancer and its treatments that can affect the psychosomatic health and quality of life of patients with cancer. The use of electronic symptom management systems (ESMSs) can help patients with cancer monitor and manage their symptoms effectively, improving their health-related outcomes. However, patients' adhesion to ESMSs decreases over time, and little is known about their real experiences with them. Therefore, it is necessary to gain a deep understanding of patients' experiences with ESMSs. Objective: The purpose of this systematic review was to synthesize qualitative studies on the experiences of patients with cancer using ESMSs. Methods: A total of 12 electronic databases, including PubMed, Web of Science, Cochrane Library, EBSCOhost, Embase, PsycINFO, ProQuest, Scopus, Wanfang database, CNKI, CBM, and VIP, were searched to collect relevant studies from the earliest available record until January 2, 2024. Qualitative and mixed methods studies published in English or Chinese were included. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement checklist) and the ENTREQ (Enhancing Transparency in Reporting the Synthesis of Qualitative Research) statement were used to improve transparency in reporting the synthesis of the qualitative research. The Critical Appraisal Skills Program (CASP) checklist was used to appraise the methodological quality of the included studies, and a meta-synthesis was conducted to interpret and synthesize the findings. Results: A total of 21 studies were included in the meta-synthesis. The experiences of patients with cancer using ESMSs were summarized into three major categories: (1) perceptions and attitudes toward ESMSs; (2) the value of ESMSs; and (3) barriers, requirements, and suggestions for ESMSs. Subsequently, 10 subcategories emerged from the 3 major categories. The meta-synthesis revealed that patients with cancer had both positive and negative experiences with ESMSs. In general, patients recognized the value of ESMSs in symptom assessment and management and were willing to use them, but they still encountered barriers and wanted them to be improved. Conclusions: This systematic review provides implications for developing future ESMSs that improve health-related outcomes for patients with cancer. Future research should focus on strengthening electronic equipment and technical support for ESMSs, improving their functional contents and participation forms, and developing personalized applications tailored to the specific needs and characteristics of patients with cancer. Trial Registration: PROSPERO CRD42023421730; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=421730 ", doi="10.2196/59061", url="https://www.jmir.org/2024/1/e59061", url="http://www.ncbi.nlm.nih.gov/pubmed/39466301" } @Article{info:doi/10.2196/52639, author="Hesso, Iman and Zacharias, Lithin and Kayyali, Reem and Charalambous, Andreas and Lavdaniti, Maria and Stalika, Evangelia and Ajami, Tarek and Acampa, Wanda and Boban, Jasmina and Nabhani-Gebara, Shereen", title="Artificial Intelligence for Optimizing Cancer Imaging: User Experience Study", journal="JMIR Cancer", year="2024", month="Oct", day="10", volume="10", pages="e52639", keywords="artificial intelligence", keywords="cancer", keywords="cancer imaging", keywords="UX design workshops", keywords="Delphi method", keywords="INCISIVE AI toolbox", keywords="user experience", abstract="Background: The need for increased clinical efficacy and efficiency has been the main force in developing artificial intelligence (AI) tools in medical imaging. The INCISIVE project is a European Union--funded initiative aiming to revolutionize cancer imaging methods using AI technology. It seeks to address limitations in imaging techniques by developing an AI-based toolbox that improves accuracy, specificity, sensitivity, interpretability, and cost-effectiveness. Objective: To ensure the successful implementation of the INCISIVE AI service, a study was conducted to understand the needs, challenges, and expectations of health care professionals (HCPs) regarding the proposed toolbox and any potential implementation barriers. Methods: A mixed methods study consisting of 2 phases was conducted. Phase 1 involved user experience (UX) design workshops with users of the INCISIVE AI toolbox. Phase 2 involved a Delphi study conducted through a series of sequential questionnaires. To recruit, a purposive sampling strategy based on the project's consortium network was used. In total, 16 HCPs from Serbia, Italy, Greece, Cyprus, Spain, and the United Kingdom participated in the UX design workshops and 12 completed the Delphi study. Descriptive statistics were performed using SPSS (IBM Corp), enabling the calculation of mean rank scores of the Delphi study's lists. The qualitative data collected via the UX design workshops was analyzed using NVivo (version 12; Lumivero) software. Results: The workshops facilitated brainstorming and identification of the INCISIVE AI toolbox's desired features and implementation barriers. Subsequently, the Delphi study was instrumental in ranking these features, showing a strong consensus among HCPs (W=0.741, P<.001). Additionally, this study also identified implementation barriers, revealing a strong consensus among HCPs (W=0.705, P<.001). Key findings indicated that the INCISIVE AI toolbox could assist in areas such as misdiagnosis, overdiagnosis, delays in diagnosis, detection of minor lesions, decision-making in disagreement, treatment allocation, disease prognosis, prediction, treatment response prediction, and care integration throughout the patient journey. Limited resources, lack of organizational and managerial support, and data entry variability were some of the identified barriers. HCPs also had an explicit interest in AI explainability, desiring feature relevance explanations or a combination of feature relevance and visual explanations within the toolbox. Conclusions: The results provide a thorough examination of the INCISIVE AI toolbox's design elements as required by the end users and potential barriers to its implementation, thus guiding the design and implementation of the INCISIVE technology. The outcome offers information about the degree of AI explainability required of the INCISIVE AI toolbox across the three services: (1) initial diagnosis; (2) disease staging, differentiation, and characterization; and (3) treatment and follow-up indicated for the toolbox. By considering the perspective of end users, INCISIVE aims to develop a solution that effectively meets their needs and drives adoption. ", doi="10.2196/52639", url="https://cancer.jmir.org/2024/1/e52639" } @Article{info:doi/10.2196/54891, author="Huang, Yanqun and Chen, Siyuan and Wang, Yongfeng and Ou, Xiaohong and Yan, Huanhuan and Gan, Xin and Wei, Zhixiao", title="Analyzing Comorbidity Patterns in Patients With Thyroid Disease Using Large-Scale Electronic Medical Records: Network-Based Retrospective Observational Study", journal="Interact J Med Res", year="2024", month="Oct", day="3", volume="13", pages="e54891", keywords="thyroid disease", keywords="comorbidity patterns", keywords="prevalence", keywords="network analysis", keywords="electronic medical records", abstract="Background: Thyroid disease (TD) is a prominent endocrine disorder that raises global health concerns; however, its comorbidity patterns remain unclear. Objective: This study aims to apply a network-based method to comprehensively analyze the comorbidity patterns of TD using large-scale real-world health data. Methods: In this retrospective observational study, we extracted the comorbidities of adult patients with TD from both private and public data sets. All comorbidities were identified using ICD-10 (International Classification of Diseases, 10th Revision) codes at the 3-digit level, and those with a prevalence greater than 2\% were analyzed. Patients were categorized into several subgroups based on sex, age, and disease type. A phenotypic comorbidity network (PCN) was constructed, where comorbidities served as nodes and their significant correlations were represented as edges, encompassing all patients with TD and various subgroups. The associations and differences in comorbidities within the PCN of each subgroup were analyzed and compared. The PageRank algorithm was used to identify key comorbidities. Results: The final cohorts included 18,311 and 50,242 patients with TD in the private and public data sets, respectively. Patients with TD demonstrated complex comorbidity patterns, with coexistence relationships differing by sex, age, and type of TD. The number of comorbidities increased with age. The most prevalent TDs were nontoxic goiter, hypothyroidism, hyperthyroidism, and thyroid cancer, while hypertension, diabetes, and lipoprotein metabolism disorders had the highest prevalence and PageRank values among comorbidities. Males and patients with benign TD exhibited a greater number of comorbidities, increased disease diversity, and stronger comorbidity associations compared with females and patients with thyroid cancer. Conclusions: Patients with TD exhibited complex comorbidity patterns, particularly with cardiocerebrovascular diseases and diabetes. The associations among comorbidities varied across different TD subgroups. This study aims to enhance the understanding of comorbidity patterns in patients with TD and improve the integrated management of these individuals. ", doi="10.2196/54891", url="https://www.i-jmr.org/2024/1/e54891", url="http://www.ncbi.nlm.nih.gov/pubmed/39361379" } @Article{info:doi/10.2196/56048, author="Hoadley, Ariel and Fleisher, Linda and Kenny, Cassidy and Kelly, JA Patrick and Ma, Xinrui and Wu, Jingwei and Guerra, Carmen and Leader, E. Amy and Alhajji, Mohammed and D'Avanzo, Paul and Landau, Zoe and Bass, Bauerle Sarah", title="Exploring Racial Disparities in Awareness and Perceptions of Oncology Clinical Trials: Cross-Sectional Analysis of Baseline Data From the mychoice Study", journal="JMIR Cancer", year="2024", month="Sep", day="30", volume="10", pages="e56048", keywords="oncology clinical trial", keywords="cancer", keywords="decision-making", keywords="racial disparity", keywords="medical mistrust", abstract="Background: Black/African American adults are underrepresented in oncology clinical trials in the United States, despite efforts at narrowing this disparity. Objective: This study aims to explore differences in how Black/African American oncology patients perceive clinical trials to improve support for the clinical trial participation decision-making process. Methods: As part of a larger randomized controlled trial, a total of 244 adult oncology patients receiving active treatment or follow-up care completed a cross-sectional baseline survey on sociodemographic characteristics, clinical trial knowledge, health literacy, perceptions of cancer clinical trials, patient activation, patient advocacy, health care self-efficacy, decisional conflict, and clinical trial intentions. Self-reported race was dichotomized into Black/African American and non--Black/African American. As appropriate, 2-tailed t tests and chi-square tests of independence were used to examine differences between groups. Results: Black/African American participants had lower clinical trial knowledge (P=.006), lower health literacy (P<.001), and more medical mistrust (all P values <.05) than non--Black/African American participants. While intentions to participate in a clinical trial, if offered, did not vary between Black/African American and non--Black/African American participants, Black/African American participants indicated lower awareness of clinical trials, fewer benefits of clinical trials, and more uncertainty around clinical trial decision-making (all P values <.05). There were no differences for other variables. Conclusions: Despite no significant differences in intent to participate in a clinical trial if offered and high overall trust in individual health care providers among both groups, beliefs persist about barriers to and benefits of clinical trial participation among Black/African American patients. Findings highlight specific ways that education and resources about clinical trials could be tailored to better suit the informational and decision-making needs and preferences of Black/African American oncology patients. ", doi="10.2196/56048", url="https://cancer.jmir.org/2024/1/e56048" } @Article{info:doi/10.2196/52018, author="Snyder, Jeremy and Zenone, Marco and Grewal, Ashmita and Caulfield, Timothy", title="Crowdfunding for Complementary and Alternative Cancer Treatments in Tijuana, Mexico: Content Analysis", journal="JMIR Cancer", year="2024", month="Aug", day="14", volume="10", pages="e52018", keywords="cancer", keywords="crowdfunding", keywords="Tijuana", keywords="CAM", keywords="patient", keywords="patients", keywords="insurance", keywords="crowdfunding platforms", keywords="GoFundMe", keywords="GiveSendGo", keywords="cancer clinic", keywords="Mexico", keywords="campaigns", keywords="cancer treatment", keywords="medical intervention", keywords="CAM cancer treatments", keywords="misinformation", keywords="alternate care", keywords="women's health", keywords="internet research", keywords="international medical tourism", keywords="alternative cancer therapy", keywords="financial toxicity", abstract="Background: Complementary and alternative (CAM) cancer treatment is often expensive and not covered by insurance. As a result, many people turn to crowdfunding to access this treatment. Objective: The aim of this study is to identify the rationales of patients with cancer seeking CAM treatment abroad by looking specifically at crowdfunding campaigns to support CAM cancer treatment in Tijuana, Mexico. Methods: We scraped the GoFundMe.com and GiveSendGo.com crowdfunding platforms for campaigns referencing CAM cancer clinics in Tijuana, initiated between January 1, 2022, and February 28, 2023. The authors created a coding framework to identify rationales for seeking CAM treatment in Tijuana. To supplement campaign metadata, we coded the beneficiary's cancer stage, type, age, specific treatment sought, whether the beneficiary died, gender, and race. Results: Patients sought CAM cancer treatment in Tijuana because the (1) treatment offers the greatest efficacy (29.9\%); (2) treatment offered domestically was not curative (23.2\%); (3) the clinic treats the whole person, and addresses the spiritual dimension of the person (20.1\%); (4) treatments are nontoxic, natural, or less invasive (18.2\%); and (5) clinic offers the newest technology (8.5\%). Campaigns raised US \$5,275,268.37 and most campaign beneficiaries were women (69.7\%) or White individuals (71.1\%). Conclusions: These campaigns spread problematic misinformation about the likely efficacy of CAM treatments, funnel money and endorsements to CAM clinics in Tijuana, and leave many campaigners short of the money needed to pay for CAM treatments while costing beneficiaries and their loved one's time, privacy, and dignity. This study affirms that Tijuana, Mexico, is a very popular destination for CAM cancer treatment. ", doi="10.2196/52018", url="https://cancer.jmir.org/2024/1/e52018" } @Article{info:doi/10.2196/50402, author="Cheng, Vienna and Sayre, C. Eric and Cheng, Vicki and Garg, Ria and Gill, Sharlene and Farooq, Ameer and De Vera, A. Mary", title="Patterns of Prescription Medication Use Before Diagnosis of Early Age-Onset Colorectal Cancer: Population-Based Descriptive Study", journal="JMIR Cancer", year="2024", month="Jul", day="12", volume="10", pages="e50402", keywords="colorectal cancer", keywords="medications", keywords="medication patterns", keywords="cancer diagnosis", keywords="prediagnosis", keywords="prescriptions", keywords="patterns", keywords="early-onset", keywords="population-based", keywords="incidence", keywords="male individuals", keywords="female individuals", keywords="health databases", keywords="pharmacology", keywords="diagnostic", keywords="descriptive study", keywords="gastroenterology", keywords="cancers", abstract="Background: Colorectal cancer (CRC) is estimated to be the fourth most common cancer diagnosis in Canada (except for nonmelanoma skin cancers) and the second and third leading cause of cancer-related death in male and female individuals, respectively. Objective: The rising incidence of early age-onset colorectal cancer (EAO-CRC; diagnosis at less than 50 years) calls for a better understanding of patients' pathway to diagnosis. Therefore, we evaluated patterns of prescription medication use before EAO-CRC diagnosis. Methods: We used linked administrative health databases in British Columbia (BC), Canada, to identify individuals diagnosed with EAO-CRC between January 1, 2010, and December 31, 2016 (hereinafter referred to as ``cases''), along with cancer-free controls (1:10), matched by age and sex. We identified all prescriptions dispensed from community pharmacies during the year prior to diagnosis and used the Anatomical Therapeutic Chemical Classification system Level 3 to group prescriptions according to the drug class. A parallel assessment was conducted for individuals diagnosed with average age-onset CRC (diagnosis at age 50 years and older). Results: We included 1001 EAO-CRC cases (n=450, 45\% female participants; mean 41.0, SD 6.1 years), and 12,989 prescriptions were filled in the year before diagnosis by 797 (79.7\%) individuals. Top-filled drugs were antidepressants (first; n=1698, 13.1\%). Drugs for peptic ulcer disease and gastroesophageal reflux disease (third; n=795, 6.1\%) were more likely filled by EAO-CRC cases than controls (odds ratio [OR] 1.4, 95\% CI 1.2-1.7) and with more frequent fills (OR 1.8, 95\% CI 1.7-1.9). We noted similar patterns for topical agents for hemorrhoids and anal fissures, which were more likely filled by EAO-CRC cases than controls (OR 7.4, 95\% CI 5.8-9.4) and with more frequent fills (OR 15.6, 95\% CI 13.1-18.6). Conclusions: We observed frequent prescription medication use in the year before diagnosis of EAO-CRC, including for drugs to treat commonly reported symptoms of EAO-CRC. ", doi="10.2196/50402", url="https://cancer.jmir.org/2024/1/e50402" } @Article{info:doi/10.2196/55601, author="Lammers, J. Eline M. and Zijlstra, M. Jos{\'e}e and Ret{\`e}l, P. Valesca and Aleman, P. Berthe M. and van Leeuwen, E. Flora and Nijdam, Annelies and ", title="Effectiveness and Cost-Effectiveness of Survivorship Care for Survivors of Hodgkin Lymphoma (INSIGHT Study): Protocol for a Multicenter Retrospective Cohort Study With a Quasi-Experimental Design", journal="JMIR Res Protoc", year="2024", month="Apr", day="18", volume="13", pages="e55601", keywords="research design", keywords="Hodgkin lymphoma", keywords="late effects of cancer treatment", keywords="survivorship care", keywords="screening", keywords="cost-effectiveness analysis", abstract="Background: Hodgkin lymphoma (HL) occurs at young ages, with the highest incidence between 20 and 40 years. While cure rates have improved to 80\%-90\% over the past decades, survivors of HL are at substantial risk of late treatment--related complications, such as cardiovascular diseases, breast cancer, severe infections, and hypothyroidism. To reduce morbidity and mortality from late treatment effects, the Dutch Better care after lymphoma, Evaluation of long-term Treatment Effects and screening Recommendations (BETER) consortium developed a survivorship care program for 5-year survivors of HL that includes risk-based screening for and treatment of (risk factors for) late adverse events. Even though several cancer survivorship care programs have been established worldwide, there is a lack of knowledge about their effectiveness in clinical practice. Objective: The Improving Nationwide Survivorship care Infrastructure and Guidelines after Hodgkin lymphoma Treatment (INSIGHT) study evaluates whether Dutch BETER survivorship care for survivors of HL decreases survivors' burden of disease from late adverse events after HL treatment and associated health care costs and improves their quality of life. Methods: The INSIGHT study is a multicenter retrospective cohort study with a quasi-experimental design and prospective follow-up, embedded in the national BETER survivorship care infrastructure. The first BETER clinics started in 2013-2016 and several other centers started or will start BETER clinics in 2019-2024. This allows us to compare survivors who did and those who did not receive BETER survivorship care in the last decade. Survivors in the intervention group are matched to controls (n=450 per group) based on sex, age at diagnosis ({\textpm}5 years), age in 2013 ({\textpm}5 years), and treatment characteristics. The primary outcome is the burden of disease in disability-adjusted life years from cardiovascular disease, breast cancer, severe infections, and hypothyroidism. In a cost-effectiveness analysis, we will assess the cost of BETER survivorship care per averted or gained disability-adjusted life year and quality-adjusted life year. Secondary outcomes are BETER clinic attendance, adherence to screening guidelines, and knowledge and distress about late effects among survivors of HL. Study data are collected from a survivor survey, a general practitioner survey, medical records, and through linkages with national disease registries. Results: The study was funded in November 2020 and approved by the institutional review board of the Netherlands Cancer Institute in July 2021. We expect to finalize recruitment by October 2024, data collection by early 2025, and data analysis by May 2025. Conclusions: INSIGHT is the first evaluation of a comprehensive survivorship program using real-world data; it will result in new information on the (cost-)effectiveness of survivorship care in survivors of HL in clinical practice. The results of this study will be used to improve the BETER program where necessary and contribute to more effective evidence-based long-term survivorship care for lymphoma survivors. International Registered Report Identifier (IRRID): PRR1-10.2196/55601 ", doi="10.2196/55601", url="https://www.researchprotocols.org/2024/1/e55601", url="http://www.ncbi.nlm.nih.gov/pubmed/38635308" } @Article{info:doi/10.2196/51338, author="Bhyat, Fatima and Makkink, Andrew and Henrico, Karien", title="Holistic Person-Centered Care in Radiotherapy: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2024", month="Apr", day="3", volume="13", pages="e51338", keywords="cancer patient", keywords="cancer", keywords="cancer care", keywords="holistic care", keywords="person-centered care", keywords="person-centered", keywords="radiologist", keywords="radiology", keywords="radiotherapist", keywords="radiotherapy", keywords="scoping review", abstract="Background: Several types of health care professionals are responsible for the care of patients with cancer throughout their engagement with the health care system. One such type is the radiotherapist. The radiotherapist not only administers treatment but is also directly involved with the patient during treatment. Despite this direct contact with the patient, the narrative tends to focus more on technical tasks than the actual patient. This task-focused interaction is often due to the highly sophisticated equipment and complex radiotherapy treatment processes involved. This often results in not meeting the psychosocial needs of the patient, and patients have acknowledged noncompliance and delayed treatment as a result. Objective: The scoping review aims to explore, chart, and map the available literature on holistic person-centered care in radiotherapy and to identify and present key concepts, definitions, methodologies, knowledge gaps, and evidence related to holistic person-centered care in radiotherapy. Methods: This protocol was developed using previously described methodological frameworks for scoping studies. The review will include both peer-reviewed and gray literature regarding holistic, person-centered care in radiotherapy. A comprehensive search strategy has been developed for MEDLINE (Ovid), which will be translated into the other included databases: Scopus, CINAHL (EBSCO), MEDLINE (PubMed), Embase (Elsevier), Cochrane Library, and the Directory of Open Access Journals. Gray literature searching will include Google (Google Books and Google Scholar), ProQuest, the WorldWideScience website, the OpenGrey website, and various university dissertation and thesis repositories. The title and abstract screening, full-text review, and relevant data extraction will be performed independently by all 3 reviewers using the Covidence (Veritas Health Innovation) software, which will also be used to guide the resolution of conflicts. Sources selected will be imported into ATLAS.ti (ATLAS.ti Scientific Software Development GmbH) for analysis, which will consist of content analysis, narrative analysis, and descriptive synthesis. Results will be presented using narrative, diagrammatic, and tabular formats. Results: The review is expected to identify research gaps that will inform current and future holistic, person-centered care in radiotherapy. The review commenced in November 2023, and the formal literature search was completed by the end of February 2024. Final results are expected to be published in a peer-reviewed journal by 2025. Conclusions: The findings of this review are expected to provide a wide variety of strategies aimed at providing holistic, person-centered care in radiotherapy, as well as to identify some gaps in the literature. These findings will be used to inform future studies aimed at designing, developing, evaluating, and implementing strategies toward improved holistic, person-centered care in radiotherapy. International Registered Report Identifier (IRRID): DERR1-10.2196/51338 ", doi="10.2196/51338", url="https://www.researchprotocols.org/2024/1/e51338", url="http://www.ncbi.nlm.nih.gov/pubmed/38569177" } @Article{info:doi/10.2196/52501, author="Brondfield, Sam and Schwede, Matthew and Johnson, P. Tyler and Arora, Shagun", title="Web-Based Scaffolds: The Feasibility of a Constructivist Approach to Oncology Fellow Learning", journal="JMIR Cancer", year="2024", month="Feb", day="23", volume="10", pages="e52501", keywords="constructivist learning", keywords="scaffolded learning", keywords="graduate medical education", keywords="fellowship training", keywords="oncology", keywords="feasibility", keywords="medical education", keywords="pilot study", keywords="study", keywords="online learning", keywords="online tool", keywords="online tools", keywords="remote learning", keywords="e-learning", keywords="training", keywords="cancer", doi="10.2196/52501", url="https://cancer.jmir.org/2024/1/e52501", url="http://www.ncbi.nlm.nih.gov/pubmed/38393780" } @Article{info:doi/10.2196/49731, author="Hinneburg, Jana and Zacher, Sandro and Berger-H{\"o}ger, Birte and Berger-Th{\"u}rmel, Karin and Kratzer, Vanessa and Steckelberg, Anke and L{\"u}hnen, Julia and ", title="Enhancing Transsectoral Interdisciplinary Patient-Centered Care for Patients With Rare Cancers: Protocol for a Mixed Methods Process Evaluation", journal="JMIR Res Protoc", year="2023", month="Oct", day="12", volume="12", pages="e49731", keywords="process evaluation", keywords="study protocol", keywords="logic model", keywords="complex intervention", keywords="coordination of care", keywords="rare cancer", keywords="mobile phone", abstract="Background: Rare cancers account for approximately 24\% of all new cancers. The category of rare tumor diseases includes almost 200 different entities. In particular, the treatment of patients with extensive care needs requires cooperation between service providers, both between sectors (outpatient and inpatient) and within sectors (eg, between different medical disciplines). The treatment pathway is associated with a high need for coordination and information sharing between providers. When crossing sectoral boundaries in the German health care system, interface problems between the outpatient and inpatient sectors can lead to gaps in care delivery. The multicomponent program Trans-sectoral Personalised Care Concept for Patients with Rare Cancers aims to optimize transsectoral cooperation and coordination of care to enhance patient involvement and the medical care coordination of patients with rare cancers. Objective: This process evaluation will contribute to answering questions about intervention fidelity and the implementation of transsectoral communication, identifying and describing the intended and nonintended effects of the intervention, and exploring the barriers to and facilitators of the implementation. Methods: We will include patients who participate in the intervention phase; all persons and staff involved in the development and implementation of the intervention (Onco Coach, psychologists, physicians on the contact platform, IT staff, and staff of the Bavarian Association of Statutory Health Insurance Physicians); physicians from the Ludwig-Maximilians-University Hospital Munich and the hospital of the Technical University Munich who are involved in the treatment of patients during the course of the project; and participating office--based hematologists and oncologists. Data collection will be conducted at the beginning, during, and at the end of the intervention using mixed methods. Data will be collected from questionnaires, document analyses, semistructured interviews, and structured observations and will cover different aspects of process evaluation. These include examining the context to explore existing patterns, changes in patterns, attitudes, and interactions; analyzing the implementation of intervention elements; and exploring the complex causal pathways and mediators of the intervention. Qualitative data will be analyzed using thematic analysis. The data will then be combined using between-methods triangulation. Results: This project received funding on March 1, 2022. The intervention phase and recruitment for the process evaluation began on March 1, 2023, and the recruitment is expected to end on September 30, 2025. At the time of protocol submission in June 2023, a total of 8 doctors from hematology and oncology practices were enrolled. Data collection began on March 14, 2023. Conclusions: The Trans-sectoral Personalised Care Concept for Patients with Rare Cancers project is a complex intervention that is to be implemented in an equally complex health care context. The process evaluation will help understand the influence of contextual factors and assess the mechanisms of change. Trial Registration: ISRCTN registry ISRCTN16441179; https://doi.org/10.1186/ISRCTN16441179 International Registered Report Identifier (IRRID): DERR1-10.2196/49731 ", doi="10.2196/49731", url="https://www.researchprotocols.org/2023/1/e49731", url="http://www.ncbi.nlm.nih.gov/pubmed/37824180" } @Article{info:doi/10.2196/46339, author="Canter, S. Kimberly and Ritterband, Lee and Freyer, R. David and Askins, A. Martha and Bava, Laura and Loucas, Caitlyn and Arasteh, Kamyar and You, Wen and Kazak, E. Anne", title="The Electronic Surviving Cancer Competently Intervention Program---a Psychosocial Digital Health Intervention for English- and Spanish-Speaking Parents of Children With Cancer: Protocol for Randomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Jun", day="2", volume="12", pages="e46339", keywords="pediatric cancer", keywords="digital health", keywords="parents", keywords="caregivers", keywords="psychosocial intervention", keywords="family systems", keywords="cultural and linguistic adaptation", abstract="Background: The psychosocial needs and risks of children with cancer and their families are well-documented including increased risk of parental distress, posttraumatic stress, and anxiety. There is a critical need to provide evidence-based psychosocial care to parents and caregivers of children with cancer. Digital health interventions are important to address many barriers to in-person intervention delivery but are not widely used in pediatric psychosocial cancer care. The COVID-19 pandemic has reinforced the need for flexible, acceptable, and accessible psychosocial digital health interventions. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative digital health intervention for parents and caregivers of children with cancer, delivered through a combination of self-guided web-based content and supplemented by 3 telehealth follow-up sessions with a trained telehealth guide. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has been developed. The self-guided web-based cores of eSCCIP/eSCCIP-SP are a mix of didactic video content, multifamily video discussion groups featuring parents of children with cancer, and hands-on web-based activities. Objective: The objective of this study is to test eSCCIP/eSCCIP-SP in a multisite randomized controlled trial, compared to an internet-based education control condition consisting of information specifically focused on concerns relevant to parents and caregivers of children with cancer. Methods: Using a randomized controlled clinical trial design, 350 eligible parents and caregivers of children with cancer will be randomly assigned to the intervention (eSCCIP/eSCCIP-SP) or an education control condition. Data will be collected at 3 time points: preintervention (prior to randomization), immediately post intervention (after 6 weeks), and at a 3-month follow-up (from baseline). Participants randomized to either condition will receive study material (eSCCIP/eSCCIP-SP intervention or education control website) in English or Spanish, based on the primary language spoken in the home and participant preference. Results: The primary study end point is a reduction in acute distress from baseline to postintervention, with secondary end points focused on reductions in symptoms of posttraumatic stress and anxiety, and improvements in coping self-efficacy and cognitive coping. An additional exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIP/eSCCIP-SP, laying the groundwork for future trials focused on dissemination and implementation, stepped-care models, and intervention refinement. Conclusions: This trial will provide necessary data to evaluate the efficacy of eSCCIP/eSCCIP-SP. This intervention has the potential to be an easily scalable and highly impactful psychosocial treatment option for parents and caregivers of children with cancer. Trial Registration: ClinicalTrials.gov NCT05294302; https://clinicaltrials.gov/ct2/show/NCT05294302 International Registered Report Identifier (IRRID): PRR1-10.2196/46339 ", doi="10.2196/46339", url="https://www.researchprotocols.org/2023/1/e46339", url="http://www.ncbi.nlm.nih.gov/pubmed/37267038" } @Article{info:doi/10.2196/39246, author="Lange-Drenth, Lukas and Schulz, Holger and Endsin, Gero and Bleich, Christiane", title="Association of the Extent of Internet Use by Patients With Cancer With Social Support Among Patients and Change in Patient-Reported Treatment Outcomes During Inpatient Rehabilitation: Cross-sectional and Longitudinal Study", journal="JMIR Cancer", year="2023", month="May", day="17", volume="9", pages="e39246", keywords="internet", keywords="internet use", keywords="social support", keywords="perceived social support", keywords="inpatients", keywords="patient-reported outcome measures", keywords="cancer", keywords="rehabilitation", keywords="distress", keywords="fatigue", keywords="pain", abstract="Background: Given the increasing number of cancer survivors and their rising survival rates, rehabilitation plays an increasingly important role. Social support among patients is an essential element of inpatient and day care rehabilitation. The internet can empower patients with cancer to become more active health care consumers and facilitate information and supportive care needs. By contrast, therapists suspect that high internet use during rehabilitation may severely limit social interactions between patients, thus interfering with the patients' rehabilitation program and jeopardizing treatment success. Objective: We hypothesized that the extent of internet use would be negatively related to social support among patients with cancer during their clinical stay as well as fewer improvements in patient-reported treatment outcomes from the first to the last day of their clinical stay. Methods: Patients with cancer participated during their inpatient rehabilitation. Cross-sectional data, such as the extent of participants' internet use and perceived social support among patients, were collected during the last week of their clinic stay. The treatment outcomes, that is, participants' levels of distress, fatigue, and pain, were collected on the first and last day of the clinic stay. We used multiple linear regression analysis to study the association between the extent of internet use and social support among patients with cancer. We used linear mixed model analyses to study the association between the extent of internet use by patients with cancer and the change in patient-reported treatment outcomes. Results: Of the 323 participants, 279 (86.4\%) participants reported that they used the internet. The extent of the internet use (t315=0.78; P=.43) was not significantly associated with the perceived social support among the participants during their clinical stay. In addition, the extent of participants' internet use during their clinical stay was not associated with changes in participants' levels of distress (F1,299=0.12; P=.73), fatigue (F1,299=0.19; P=.67), and pain (F1,303=0.92; P=.34) from the first to the last day of their clinical stay. Conclusions: The extent of internet use does not seem to be negatively associated with the perceived social support among patients with cancer or with the change in patients' levels of distress, fatigue, or pain from the first to the last day of their clinical stay. ", doi="10.2196/39246", url="https://cancer.jmir.org/2023/1/e39246", url="http://www.ncbi.nlm.nih.gov/pubmed/37195742" } @Article{info:doi/10.2196/46657, author="Hirsch, A. Erin and Studts, L. Jamie", title="Using User-Centered Design to Facilitate Adherence to Annual Lung Cancer Screening: Protocol for a Mixed Methods Study for Intervention Development", journal="JMIR Res Protoc", year="2023", month="Apr", day="14", volume="12", pages="e46657", keywords="health information processing", keywords="intervention design", keywords="lung cancer", keywords="lung cancer screening", keywords="LCS", keywords="mixed methods", keywords="photovoice", keywords="user-centered design", abstract="Background: Lung cancer is the leading cause of cancer-related death in the United States, with the majority of lung cancer occurrence diagnosed after the disease has already metastasized. Lung cancer screening (LCS) with low-dose computed tomography can diagnose early-stage disease, especially when eligible individuals participate in screening on a yearly basis. Unfortunately, annual adherence has emerged as a challenge for academic and community screening programs, endangering the individual and population health benefits of LCS. Reminder messages have effectively increased adherence rates in breast, colorectal, and cervical cancer screenings but have not been tested with LCS participants who experience unique barriers to screening associated with the stigma of smoking and social determinants of health. Objective: This research aims to use a theory-informed, multiphase, and mixed methods approach with LCS experts and participants to develop a set of clear and engaging reminder messages to support LCS annual adherence. Methods: In aim 1, survey data informed by the Cognitive-Social Health Information Processing model will be collected to assess how LCS participants process health information aimed at health protective behavior to develop content for reminder messages and pinpoint options for message targeting and tailoring. Aim 2 focuses on identifying themes for message imagery through a modified photovoice activity that asks participants to identify 3 images that represent LCS and then participate in an interview about the selection, likes, and dislikes of each photo. A pool of candidate messages for multiple delivery platforms will be developed in aim 3, using results from aim 1 for message content and aim 2 for imagery selection. The refinement of message content and imagery combinations will be completed through iterative feedback from LCS experts and participants. Results: Data collection began in July 2022 and will be completed by May 2023. The final reminder message candidates are expected to be completed by June 2023. Conclusions: This project proposes a novel approach to facilitate adherence to annual LCS through the development of reminder messages that embrace content and imagery representative of the target population directly in the design process. Developing effective strategies to increase LCS adherence is instrumental in achieving optimal LCS outcomes at individual and population health levels. International Registered Report Identifier (IRRID): DERR1-10.2196/46657 ", doi="10.2196/46657", url="https://www.researchprotocols.org/2023/1/e46657", url="http://www.ncbi.nlm.nih.gov/pubmed/37058339" } @Article{info:doi/10.2196/46335, author="Roberts, Amanda Danielle and Watson, Eila and Macdonald, Christopher and Khan, Yarunnessa and Prideaux, Sarah and Puthiyakunnel Saji, Alwin and Postaleniec, Emilia and Selvakumar, Jashan and Haghighat Ghahfarokhi, Mahta and Davidson, Brian and Gurusamy, Kurinchi", title="Management of Pain and Cachexia in Pancreatic Cancer: Protocol for Two Systematic Reviews, Network Meta-Analysis, Surveys, and Focus Groups", journal="JMIR Res Protoc", year="2023", month="Apr", day="4", volume="12", pages="e46335", keywords="cachexia", keywords="pain relief", keywords="palliative care", keywords="pancreatic cancer", keywords="quality of life", keywords="systematic review", abstract="Background: ?Approximately 75\% of people with pancreatic cancer experience pain, and >50\% of them have cachexia (weakness and wasting of the body). However, there is considerable uncertainty regarding the management of these distressing symptoms. Objective: ?Our primary objectives are to compare the relative benefits and harms of different interventions for pain in people with unresectable pancreatic cancer and for prevention and treatment of cachexia due to pancreatic cancer, through systematic reviews and network meta-analysis. Our secondary objectives are to develop an evidence-based clinical care pathway to manage pain and prevent and treat cachexia in people with pancreatic cancer through surveys and focus groups involving patients, carers, and health care professionals. Methods: ?We will perform 2 systematic reviews of the literature related to pain and cachexia in people with pancreatic cancer using searches from Cochrane Library, MEDLINE, Embase, Science Citation Index, and trial registries. Two researchers will independently screen for eligibility and identify randomized controlled trials (no language or publication status restriction), comparing interventions for pain or cachexia based on full-texts for articles shortlisted during screening. We will assess risk of bias in the trials using the Cochrane risk of bias tool (version 2.0) and obtain data related to baseline prognostic characteristics, potential effect modifiers and outcome data related to overall survival, health-related quality of life, treatment-related complications, and resource utilisation. We aim to conduct network meta-analysis on outcomes with multiple treatment comparisons where possible, otherwise, meta-analysis with direct comparisons, or narrative synthesis. We will perform various subgroup and sensitivity analyses. Using information obtained from both systematic reviews, we will conduct 2 surveys: one directed to patients or carers to assess acceptability of interventions, and the other to health care professionals to assess feasibility of delivery in the National Health Service. Four mixed focus groups will be conducted to evaluate findings and foster consensus in the development of the care pathway. Results: ?Funding was awarded from April 2022 (NIHR202727). Both systematic review protocols were prospectively registered on PROSPERO in May 2022. Formal searches began thereafter. Approval by the University College London Research Ethics Committee (23563/001) was received in December 2022. Data collection began in January 2023; data analysis will begin in May 2023 (completion expected by October 2023). Conclusions: ?This study will comprehensively encompass major interventions for management of pain in people with unresectable pancreatic cancer, and prevention and treatment of cachexia in people with pancreatic cancer. Key stakeholders will facilitate the development of an evidence-based care pathway, ensuring both acceptability and feasibility. The project ends in April 2024 and published results are expected within 12 months of completion. We aim to present the findings through patient group websites, conferences, and publications, irrespective of the findings, in a peer-reviewed journal. International Registered Report Identifier (IRRID): DERR1-10.2196/46335 ", doi="10.2196/46335", url="https://www.researchprotocols.org/2023/1/e46335", url="http://www.ncbi.nlm.nih.gov/pubmed/37014692" } @Article{info:doi/10.2196/42350, author="Miser, S. James and Shia, Ben-Chang and Kao, Yi-Wei and Liu, Yen-Lin and Chen, Shih-Yen and Ho, Wan-Ling", title="The Health Care Utilization and Medical Costs in Long-Term Follow-Up of Children Diagnosed With Leukemia, Solid Tumor, or Brain Tumor: Population-Based Study Using the National Health Insurance Claims Data", journal="JMIR Public Health Surveill", year="2023", month="Mar", day="2", volume="9", pages="e42350", keywords="brain tumor", keywords="cancer survivor", keywords="children", keywords="cost of care", keywords="health care", keywords="health resource", keywords="leukemia", keywords="long-term follow-up", keywords="population-based study", keywords="solid tumor", abstract="Background: Childhood cancer survivors are at a high risk of medical consequences of their disease and treatment. There is growing information about the long-term health issues of childhood cancer survivors; however, there are very few studies describing the health care utilization and costs for this unique population. Understanding their utilization of health care services and costs will provide the basis for developing strategies to better serve these individuals and potentially reduce the cost. Objective: This study aims to determine the utilization of health services and costs for long-term survivors of childhood cancer in Taiwan. Methods: This is a nationwide, population-based, retrospective case-control study. We analyzed the claims data of the National Health Insurance that covers 99\% of the Taiwanese population of 25.68 million. A total of 33,105 children had survived for at least 5 years after the first appearance of a diagnostic code of cancer or a benign brain tumor before the age of 18 years from 2000 to 2010 with follow-up to 2015. An age- and gender-matched control group of 64,754 individuals with no cancer was randomly selected for comparison. Utilization was compared between the cancer and no cancer groups by $\chi$2 test. The annual medical expense was compared by the Mann-Whitney U test and Kruskal-Wallis rank-sum test. Results: At a median follow-up of 7 years, childhood cancer survivors utilized a significantly higher proportion of medical center, regional hospital, inpatient, and emergency services in contrast to no cancer individuals: 57.92\% (19,174/33,105) versus 44.51\% (28,825/64,754), 90.66\% (30,014/33,105) versus 85.70\% (55,493/64,754), 27.19\% (9000/33,105) versus 20.31\% (13,152/64,754), and 65.26\% (21,604/33,105) versus 59.36\% (38,441/64,754), respectively (all P<.001). The annual total expense (median, interquartile range) of childhood cancer survivors was significantly higher than that of the comparison group (US \$285.56, US \$161.78-US \$535.80 per year vs US \$203.90, US \$118.98-US \$347.55 per year; P<.001). Survivors with female gender, diagnosis before the age of 3 years, and diagnosis of brain cancer or a benign brain tumor had significantly higher annual outpatient expenses (all P<.001). Moreover, the analysis of outpatient medication costs showed that hormonal and neurological medications comprised the 2 largest costs in brain cancer and benign brain tumor survivors. Conclusions: Survivors of childhood cancer and a benign brain tumor had higher utilization of advanced health resources and higher costs of care. The design of the initial treatment plan minimizing long-term consequences, early intervention strategies, and survivorship programs have the potential to mitigate costs of late effects due to childhood cancer and its treatment. ", doi="10.2196/42350", url="https://publichealth.jmir.org/2023/1/e42350", url="http://www.ncbi.nlm.nih.gov/pubmed/36862495" } @Article{info:doi/10.2196/41812, author="Daugherty, C. Emily and Mascia, Anthony and Zhang, Yong and Lee, Eunsin and Xiao, Zhiyan and Sertorio, Mathieu and Woo, Jennifer and McCann, Claire and Russell, Kenneth and Levine, Lisa and Sharma, Ricky and Khuntia, Deepak and Bradley, Jeffrey and Simone II, B. Charles and Perentesis, John and Breneman, John", title="FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01): Protocol for the First Prospective Feasibility Study", journal="JMIR Res Protoc", year="2023", month="Jan", day="5", volume="12", pages="e41812", keywords="bone metastases", keywords="FLASH", keywords="proton therapy", keywords="external beam radiotherapy", keywords="palliative radiotherapy", keywords="extremities", keywords="pain relief", keywords="ultra-high dose rate", keywords="radiation therapy", keywords="cancer treatment", keywords="toxicity", keywords="oncology", keywords="radiotherapy", abstract="Background: In preclinical studies, FLASH therapy, in which radiation delivered at ultrahigh dose rates of ?40 Gy per second, has been shown to cause less injury to normal tissues than radiotherapy delivered at conventional dose rates. This paper describes the protocol for the first-in-human clinical investigation of proton FLASH therapy. Objective: FAST-01 is a prospective, single-center trial designed to assess the workflow feasibility, toxicity, and efficacy of FLASH therapy for the treatment of painful bone metastases in the extremities. Methods: Following informed consent, 10 subjects aged ?18 years with up to 3 painful bone metastases in the extremities (excluding the feet, hands, and wrists) will be enrolled. A treatment field selected from a predefined library of plans with fixed field sizes (from 7.5 cm {\texttimes} 7.5 cm up to 7.5 cm {\texttimes} 20 cm) will be used for treatment. Subjects will receive 8 Gy of radiation in a single fraction---a well-established palliative regimen evaluated in prior investigations using conventional dose rate photon radiotherapy. A FLASH-enabled Varian ProBeam proton therapy unit will be used to deliver treatment to the target volume at a dose rate of ?40 Gy per second, using the plateau (transmission) portion of the proton beam. After treatment, subjects will be assessed for pain response as well as any adverse effects of FLASH radiation. The primary end points include assessing the workflow feasibility and toxicity of FLASH treatment. The secondary end point is pain response at the treated site(s), as measured by patient-reported pain scores, the use of pain medication, and any flare in bone pain after treatment. The results will be compared to those reported historically for conventional dose rate photon radiotherapy, using the same radiation dose and fractionation. Results: FAST-01 opened to enrollment on November 3, 2020. Initial results are expected to be published in 2022. Conclusions: The results of this investigation will contribute to further developing and optimizing the FLASH-enabled ProBeam proton therapy system workflow. The pain response and toxicity data acquired in our study will provide a greater understanding of FLASH treatment effects on tumor responses and normal tissue toxicities, and they will inform future FLASH trial designs. Trial Registration: : ClinicalTrials.gov NCT04592887; http://clinicaltrials.gov/ct2/show/NCT04592887 International Registered Report Identifier (IRRID): DERR1-10.2196/41812 ", doi="10.2196/41812", url="https://www.researchprotocols.org/2023/1/e41812", url="http://www.ncbi.nlm.nih.gov/pubmed/36206189" } @Article{info:doi/10.2196/38874, author="Patel, Sunil and McClintock, Chad and Booth, Christopher and Merchant, Shaila and Heneghan, Carl and Bankhead, Clare", title="The Variations in Care and Real-world Outcomes in Individuals With Rectal Cancer: Protocol for the Ontario Rectal Cancer Cohort", journal="JMIR Res Protoc", year="2022", month="Aug", day="5", volume="11", number="8", pages="e38874", keywords="rectal cancer", keywords="survival", keywords="adherence to care", keywords="regional variability", abstract="Background: Individuals with rectal cancer require a number of pretreatment investigations, often require multidisciplinary treatment, and require ongoing follow-ups after treatment is completed. Due to the complexity of treatments, large variations in practice patterns and outcomes have been identified. At present, few comprehensive, population-level data sets are available for assessing interventions and outcomes in this group. Objective: Our study aims to create a comprehensive database of individuals with rectal cancer who have been treated in a single-payer, universal health care system. This database will provide an excellent resource that investigators can use to study variations in the delivery of care to and real-world outcomes of this population. Methods: The Ontario Rectal Cancer Cohort database will include comprehensive details about the management and outcomes of individuals with rectal cancer who have been diagnosed in Ontario, Canada (population: 14.6 million), between 2010 and 2019. Linked administrative data sets will be used to construct this comprehensive database. Individual and care provider characteristics, investigations, treatments, follow-ups, and outcomes will be derived and linked. Surgical pathology details, including the stage of disease, histopathology characteristics, and the quality of surgical excision, will be included. Ethics approval for this study was obtained through the Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board. Results: Approximately 20,000 individuals who meet the inclusion criteria for this study have been identified. Data analysis is ongoing, with an expected completion date of March 2023. This study was funded through the Canadian Institute of Health Research Operating Grant. Conclusions: The Ontario Rectal Cancer Cohort will include a comprehensive data set of individuals with rectal cancer who received care within a single-payer, universal health care system. This cohort will be used to determine factors associated with regional variability and adherence to recommended care, and it will allow for an assessment of a number of understudied areas within the delivery of rectal cancer treatment. International Registered Report Identifier (IRRID): RR1-10.2196/38874 ", doi="10.2196/38874", url="https://www.researchprotocols.org/2022/8/e38874", url="http://www.ncbi.nlm.nih.gov/pubmed/35930352" } @Article{info:doi/10.2196/39277, author="Chima, Sophie and Martinez-Gutierrez, Javiera and Hunter, Barbara and Manski-Nankervis, Jo-Anne and Emery, Jon", title="Optimization of a Quality Improvement Tool for Cancer Diagnosis in Primary Care: Qualitative Study", journal="JMIR Form Res", year="2022", month="Aug", day="4", volume="6", number="8", pages="e39277", keywords="cancer", keywords="primary health care", keywords="diagnosis", keywords="quality improvement", keywords="clinical decision support tool", keywords="general practice", keywords="pilot", keywords="feasibility", keywords="Clinical Performance Feedback Intervention Theory", abstract="Background: The most common route to a diagnosis of cancer is through primary care. Delays in diagnosing cancer occur when an opportunity to make a timely diagnosis is missed and is evidenced by patients visiting the general practitioner (GP) on multiple occasions before referral to a specialist. Tools that minimize prolonged diagnostic intervals and reduce missed opportunities to investigate patients for cancer are therefore a priority. Objective: This study aims to explore the usefulness and feasibility of a novel quality improvement (QI) tool in which algorithms flag abnormal test results that may be indicative of undiagnosed cancer. This study allows for the optimization of the cancer recommendations before testing the efficacy in a randomized controlled trial. Methods: GPs, practice nurses, practice managers, and consumers were recruited to participate in individual interviews or focus groups. Participants were purposively sampled as part of a pilot and feasibility study, in which primary care practices were receiving recommendations relating to the follow-up of abnormal test results for prostate-specific antigen, thrombocytosis, and iron-deficiency anemia. The Clinical Performance Feedback Intervention Theory (CP-FIT) was applied to the analysis using a thematic approach. Results: A total of 17 interviews and 3 focus groups (n=18) were completed. Participant themes were mapped to CP-FIT across the constructs of context, recipient, and feedback variables. The key facilitators to use were alignment with workflow, recognized need, the perceived importance of the clinical topic, and the GPs' perception that the recommendations were within their control. Barriers to use included competing priorities, usability and complexity of the recommendations, and knowledge of the clinical topic. There was consistency between consumer and practitioner perspectives, reporting language concerns associated with the word cancer, the need for more patient-facing resources, and time constraints of the consultation to address patients' worries. Conclusions: There was a recognized need for the QI tool to support the diagnosis of cancer in primary care, but barriers were identified that hindered the usability and actionability of the recommendations in practice. In response, the tool has been refined and is currently being evaluated as part of a randomized controlled trial. Successful and effective implementation of this QI tool could support the detection of patients at risk of undiagnosed cancer in primary care and assist in preventing unnecessary delays. ", doi="10.2196/39277", url="https://formative.jmir.org/2022/8/e39277", url="http://www.ncbi.nlm.nih.gov/pubmed/35925656" } @Article{info:doi/10.2196/36323, author="Viola, S. Adrienne and Levonyan-Radloff, Kristine and Masterson, Margaret and Manne, L. Sharon and Hudson, V. Shawna and Devine, A. Katie", title="Development of a Self-management and Peer-Mentoring Intervention to Improve Transition Readiness Among Young Adult Survivors of Pediatric Cancer: Formative Qualitative Research Study", journal="JMIR Form Res", year="2022", month="Aug", day="3", volume="6", number="8", pages="e36323", keywords="self-management", keywords="peer mentoring", keywords="cancer survivorship", keywords="long-term follow-up care", abstract="Background: Childhood cancer survivors require lifelong risk-based follow-up care. It should be noted that less than one-third of adult survivors of childhood cancer report any survivor-focused care, and fewer than 1 in 5 obtain risk-based follow-up care. It is thought that this may be due to inadequate transition readiness, including low levels of knowledge, skills, motivation, and resources to make the transition to independent self-management of follow-up care. Interventions that focus specifically on improving the transition from parent-managed to self-managed care are needed. Theory and prior research suggest that targeting self-management skills and using peer mentoring may be innovative strategies to improve transition readiness. Objective: This study aims to identify the content of a self-management intervention to improve transition readiness among adolescent and young adult (AYA) survivors. Methods: Intervention development occurred in 3 stages: formative research with AYA survivors to identify barriers and facilitators to obtaining risk-based survivorship care, content development using feedback from multiple stakeholders (AYA survivors, parents, and providers), and content refinement (usability testing) of the initial proposed educational modules for the program. Content analysis, guided by the social-ecological model of AYA readiness for transition, was used to identify themes and develop and refine the content for the intervention. Results: A total of 19 AYA survivors participated in the formative research stage, and 10 AYA survivors, parents, and health care providers participated in the content development and refinement stages. The major barrier and facilitator themes identified included knowledge of cancer history and risks; relationships with health care providers; relationships with family members involved in care; emotions about health, follow-up care, and transfer of care; and lifestyle behaviors and life transitions. These themes were translated into 5 self-management modules: understanding treatment history and the survivorship care plan, managing health care logistics and insurance, communicating with health care providers and family members involved in care, dealing with emotions, and staying healthy in the context of life transitions. Feedback from the key stakeholders indicated that the content was relevant but should include participative elements (videos and tailored feedback) to make the intervention more engaging. The AYA survivors were receptive to the idea of working with a peer mentor and expressed a preference for using SMS text messaging, telephone calls, or videoconference to communicate with their mentor. Conclusions: Incorporating AYA survivors, parents, and providers in the design was essential to developing the content of a self-management and peer-mentoring intervention. AYA survivors confirmed the important targets for the intervention and facilitated design decisions in line with our target users' preferences. The next step will be to conduct a single-arm trial to determine the feasibility and acceptability of the proposed intervention among AYA survivors of childhood cancer. ", doi="10.2196/36323", url="https://formative.jmir.org/2022/8/e36323", url="http://www.ncbi.nlm.nih.gov/pubmed/35921137" } @Article{info:doi/10.2196/39288, author="Selmouni, Farida and Guy, Marine and Muwonge, Richard and Nassiri, Abdelhak and Lucas, Eric and Basu, Partha and Sauvaget, Catherine", title="Effectiveness of Artificial Intelligence--Assisted Decision-making to Improve Vulnerable Women's Participation in Cervical Cancer Screening in France: Protocol for a Cluster Randomized Controlled Trial (AppDate-You)", journal="JMIR Res Protoc", year="2022", month="Aug", day="2", volume="11", number="8", pages="e39288", keywords="cervical cancer", keywords="screening", keywords="chatbot", keywords="decision aid", keywords="artificial intelligence", keywords="cluster randomized controlled trial", abstract="Background: The French organized population-based cervical cancer screening (CCS) program transitioned from a cytology-based to a human papillomavirus (HPV)--based screening strategy in August 2020. HPV testing is offered every 5 years, starting at the age of 30 years. In the new program, women are invited to undergo an HPV test at a gynecologist's, primary care physician's, or midwife's office, a private clinic or health center, family planning center, or hospital. HPV self-sampling (HPVss) was also made available as an additional approach. However, French studies reported that less than 20\% of noncompliant women performed vaginal self-sampling when a kit was sent to their home. Women with lower income and educational levels participate less in CCS. Lack of information about the disease and the benefits of CCS were reported as one of the major barriers among noncompliant women. This barrier could be addressed by overcoming disparities in HPV- and cervical cancer--related knowledge and perceptions about CCS. Objective: This study aimed to assess the effectiveness of a chatbot-based decision aid to improve women's participation in the HPVss detection-based CCS care pathway. Methods: AppDate-You is a 2-arm cluster randomized controlled trial (cRCT) nested within the French organized CCS program. Eligible women are those aged 30-65 years who have not been screened for CC for more than 4 years and live in the disadvantaged clusters in the Occitanie Region, France. In total, 32 clusters will be allocated to the intervention and control arms, 16 in each arm (approximately 4000 women). Eligible women living in randomly selected disadvantaged clusters will be identified using the Regional Cancer Screening Coordinating Centre of Occitanie (CRCDC-OC) database. Women in the experimental group will receive screening reminder letters and HPVss kits, combined with access to a chatbot-based decision aid tailored to women with lower education attainment. Women in the control group will receive the reminder letters and HPVss kits (standard of care). The CRCDC-OC database will be used to check trial progress and assess the intervention's impact. The trial has 2 primary outcomes: (1) the proportion of screening participation within 12 months among women recalled for CCS and (2) the proportion of HPVss-positive women who are ``well-managed'' as stipulated in the French guidelines. Results: To date, the AppDate-You study group is preparing and developing the chatbot-based decision aid (intervention). The cRCT will be conducted once the decision aid has been completed and validated. Recruitment of women is expected to begin in January 2023. Conclusions: This study is the first to evaluate the impact of a chatbot-based decision aid to promote the CCS program and increase its performance. The study results will inform policy makers and health professionals as well as the research community. Trial Registration: ClinicalTrials.gov NCT05286034; https://clinicaltrials.gov/ct2/show/NCT05286034 International Registered Report Identifier (IRRID): PRR1-10.2196/39288 ", doi="10.2196/39288", url="https://www.researchprotocols.org/2022/8/e39288", url="http://www.ncbi.nlm.nih.gov/pubmed/35771872" } @Article{info:doi/10.2196/34292, author="Regueiro, Cristina and Codesido, Laura and Garc{\'i}a-Nimo, Laura and Zarraqui{\~n}os, Sara and Remedios, David and Rodr{\'i}guez-Blanco, Arturo and Sinde, Esteban and Fern{\'a}ndez-de-Ana, Catalina and Cubiella, Joaqu{\'i}n", title="Effect of the Nutraceutical Micodigest 2.0 on the Complication Rate of Colorectal Cancer Surgery With Curative Intent: Protocol for a Placebo-Controlled Double-blind Randomized Clinical Trial", journal="JMIR Res Protoc", year="2022", month="May", day="16", volume="11", number="5", pages="e34292", keywords="colorectal cancer", keywords="surgery complications", keywords="gut microbiota", keywords="inflammatory pattern", keywords="nutritional status", keywords="nutraceutical", keywords="postsurgery", keywords="colorectal", keywords="cancer", keywords="colon", abstract="Background: Most colorectal cancer patients diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used for the prevention of infectious postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in colorectal cancer patients. The combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. Objective: Based on this hypothesis, we have designed a double-bind, randomized clinical trial to evaluate the effect of the nutraceutical fungal extract Micodigest 2.0 on complications of surgery for colorectal cancer resection. Methods: Colorectal cancer candidates for surgery will be considered for inclusion in the study. After evaluation by the multidisciplinary tumor board, patients who meet selection criteria will be screened, stratified according to tumor location, and randomly allocated to be treated with Micodigest 2.0 or placebo. Treatment will be continued until admission for surgery (4-6 weeks). Participants will undergo a medical and clinical evaluation including baseline and preadmission quality of life, microbiome composition, inflammatory and nutritional status, adverse events, and adherence assessments. The main end point of the study is the surgery complication rate. We will evaluate complications using the Clavien-Dindo classification. It will be necessary to recruit 144 patients to find a relevant clinical difference. We will also evaluate the effect of the nutraceutical on microbiome composition, inflammatory response, nutritional status, and quality of life, as well as the effect of these variables on surgical complications. Results: This study was funded in 2020 by the Center for Industrial Technology Development. Recruitment began in September 2021 and is expected to be completed in September 2022. Data will be analyzed and the results will be disseminated in 2023. Conclusions: The results of this protocol study could help to reduce surgery complications in patients with colorectal cancer using the new treatment Micodigest. This study could also identify new features associated with colorectal surgery complications. In summary, this study trial could improve the management of colorectal cancer patients. Trial Registration: Clinical Trials.gov NCT04821258; https://clinicaltrials.gov/ct2/show/NCT04821258 International Registered Report Identifier (IRRID): DERR1-10.2196/34292 ", doi="10.2196/34292", url="https://www.researchprotocols.org/2022/5/e34292", url="http://www.ncbi.nlm.nih.gov/pubmed/35576566" } @Article{info:doi/10.2196/37709, 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/10.2196/35243, author="Ronellenfitsch, Ulrich and Mathis, Nika and Friedrichs, Juliane and Kleeff, J{\"o}rg", title="Lymph Node Yield in Gastrointestinal Cancer Surgery With or Without Prior Neoadjuvant Therapy: Protocol for a Systematic Review and Meta-analysis", journal="JMIR Res Protoc", year="2022", month="Apr", day="28", volume="11", number="4", pages="e35243", keywords="lymph node yield", keywords="lymph node harvest", keywords="neoadjuvant therapy", keywords="neoadjuvant chemotherapy", keywords="neoadjuvant radiotherapy", keywords="surgery", keywords="resection", keywords="gastrointestinal cancer", keywords="chemotherapy", keywords="cancer", abstract="Background: Lymph node yield is the number of lymph nodes retrieved during oncological resection and histopathologically identified in the resection specimen. It is an important surrogate parameter for assessing the oncological radicality of the resection of gastrointestinal carcinomas, as well as a prognostic factor in these diseases. It remains unclear if and to what extent neoadjuvant chemotherapy, radiotherapy, or chemoradiotherapy, which have become established treatments for carcinoma of the esophagus, stomach, and rectum and are increasingly used in pancreatic carcinoma, affect the lymph node yield. Objective: This systematic review with meta-analysis is conducted with the aim of summarizing the available evidence regarding the lymph node yield, an oncological surrogate marker, in patients with gastrointestinal carcinomas undergoing surgery after neoadjuvant therapy compared to those undergoing surgery without neoadjuvant therapy. Methods: Randomized and nonrandomized studies comparing oncological resection of esophageal, stomach, pancreatic, and rectal carcinoma with and without prior neoadjuvant therapy are eligible for inclusion regardless of study design. Publications will be identified with a defined search strategy in 2 electronic databases: PubMed and Cochrane Library. The primary endpoint of the analysis is the number of lymph nodes identified in the resected specimen. Secondary endpoints include the number of harvested metastatic lymph nodes, operation time, postoperative complications, pathological TNM staging, and overall and recurrence-free survival time. Using suitable statistical methods, the endpoints between patients with and without neoadjuvant therapy, as well as in defined subgroups (neoadjuvant chemotherapy, radiotherapy, or chemoradiotherapy; and patients with esophageal, gastric, pancreatic, or rectal cancer), will be compared. Results: The literature search and data collection started in October 2021. Results are expected to be published in mid-2022. Conclusions: This meta-analysis will provide the most up-to-date and complete summary of the evidence on an association between neoadjuvant therapy and lymph node yield in gastrointestinal cancer surgery. The underlying hypothesis is that neoadjuvant therapy decreases the number and size of lymph nodes through lymphocyte depletion and radiation-induced fibrosis, thus leading to a lower possible lymph node yield. The findings of the meta-analysis will show if this hypothesis is supported by evidence. Trial Registration: PROSPERO CRD218459; https://www.crd.york.ac.uk/prospero/display\_record.php?ID=CRD42021218459 International Registered Report Identifier (IRRID): DERR1-10.2196/35243 ", doi="10.2196/35243", url="https://www.researchprotocols.org/2022/4/e35243", url="http://www.ncbi.nlm.nih.gov/pubmed/35482374" } @Article{info:doi/10.2196/33240, author="Mudaranthakam, Pal Dinesh and Gajewski, Byron and Krebill, Hope and Coulter, James and Springer, Michelle and Calhoun, Elizabeth and Hughes, Dorothy and Mayo, Matthew and Doolittle, Gary", title="Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants", journal="JMIR Cancer", year="2022", month="Apr", day="21", volume="8", number="2", pages="e33240", keywords="rural residents", keywords="clinical trials", keywords="screening", keywords="cancer", keywords="patients", keywords="lung cancer", keywords="health policy epidemiology", keywords="cancer patients", keywords="electronic screening logs", keywords="electronic screening", abstract="Background: The National Clinical Trials Network program conducts phase 2 or phase 3 treatment trials across all National Cancer Institute's designated cancer centers. Participant accrual across these clinical trials is a critical factor in deciding their success. Cancer centers that cater to rural populations, such as The University of Kansas Cancer Center, have an additional responsibility to ensure rural residents have access and are well represented across these studies. Objective: There are scant data available regarding the factors that act as barriers to the accrual of rural residents in these clinical trials. This study aims to use electronic screening logs that were used to gather patient data at several participating sites in The Kansas University of Cancer Center's Catchment area. Methods: Screening log data were used to assess what clinical trial participation barriers are faced by these patients. Additionally, the differences in clinical trial participation barriers were compared between rural and urban participating sites. Results: Analysis revealed that the hospital location rural urban category, defined as whether the hospital was in an urban or rural setting, had a medium effect on enrolment of patients in breast cancer and lung cancer trials (Cohen d=0.7). Additionally, the hospital location category had a medium effect on the proportion of recurrent lung cancer cases at the time of screening (d=0.6). Conclusions: In consideration of the financially hostile nature of cancer treatment as well as geographical and transportation barriers, clinical trials extended to rural communities are uniquely positioned to alleviate the burden of nonmedical costs in trial participation. However, these options can be far less feasible for patients in rural settings. Since the number of patients with cancer who are eligible for a clinical trial is already limited by the stringent eligibility criteria required of such a complex disease, improving accessibility for rural patients should be a greater focus in health policy. ", doi="10.2196/33240", url="https://cancer.jmir.org/2022/2/e33240", url="http://www.ncbi.nlm.nih.gov/pubmed/35451964" } @Article{info:doi/10.2196/27775, author="Underwood, Jody and McCloskey, Susan and Raldow, Ann and Kishan, Amar and Zalkin, Chad and Navarro, Daniel and Holt, Scott Lisa and Webb, Andrew and Lynch, A. Kathleen and Atkinson, M. Thomas", title="Developing a Mobile Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Administration System to Capture Postradiation Toxicity in Oncology: Usability and Feasibility Study", journal="JMIR Form Res", year="2022", month="Apr", day="12", volume="6", number="4", pages="e27775", keywords="neoplasms", keywords="patient outcome assessment", keywords="radiation oncology", keywords="toxicity", keywords="public health informatics", keywords="mobile apps", keywords="mobile health", keywords="mobile administration system", keywords="radiation therapy", keywords="eHealth", abstract="Background: Accurate self-reported symptomatic toxicity documentation via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is essential throughout cancer treatment to ensure safety and understand therapeutic efficacy. However, the capture of accurate toxicities from patients undergoing radiation therapy is challenging because this is generally provided only at the time of scheduled visits. Objective: This study seeks to establish the usability and feasibility of a mobile PRO-CTCAE Administration System (mPROS) to capture toxicities related to radiation therapy. Methods: English-speaking adult patients who were undergoing radiation therapy for cancer were enrolled and given a brief demonstration of the Say All Your Symptoms (SAYS) and Symptom Tracking Entry Program (STEP) interfaces of the mPROS app, followed by a patient-use phase where patient actions were observed as they navigated mPROS to enter toxicities. Patient feedback was captured via a semistructured interview and brief questionnaire. Results: We enrolled 25 patients (age: mean 60.7 years; females: n=13, 52\%; White patients: n=13; 52\%; non-Hispanic patients: n=19, 76\%; college graduates: n=17, 68\%). Patients almost equally preferred the SAYS (n=14, 56\%) or STEP (n=11, 44\%) interfaces, with 21 patients (84\%) agreeing that they would use mPROS to report their symptoms to their health care team and 19 patients (76\%) agreeing that they would recommend mPROS to others. Conclusions: The mPROS app is usable and feasible for facilitating the patient reporting of radiation therapy--related symptomatic toxicities. A revised version of mPROS that incorporates patient input and includes electronic health record integration is being developed and validated as part of a multicenter trial. ", doi="10.2196/27775", url="https://formative.jmir.org/2022/4/e27775", url="http://www.ncbi.nlm.nih.gov/pubmed/35412466" } @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/10.2196/33355, author="Goodman, William and Bagnall, Anne-Marie and Ashley, Laura and Azizoddin, Desiree and Muehlensiepen, Felix and Blum, David and Bennett, I. Michael and Allsop, Matthew", title="The Extent of Engagement With Telehealth Approaches by Patients With Advanced Cancer: Systematic Review", journal="JMIR Cancer", year="2022", month="Feb", day="17", volume="8", number="1", pages="e33355", keywords="systematic review", keywords="advanced cancer", keywords="engagement", keywords="digital health", keywords="telehealth", keywords="mobile phone", abstract="Background: Telehealth approaches are increasingly being used to support patients with advanced diseases, including cancer. Evidence suggests that telehealth is acceptable to most patients; however, the extent of and factors influencing patient engagement remain unclear. Objective: The aim of this review is to characterize the extent of engagement with telehealth interventions in patients with advanced, incurable cancer reported in the international literature. Methods: This systematic review was registered with PROSPERO (International Prospective Register of Systematic Reviews) and is reported in line with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. A comprehensive search of databases was undertaken for telehealth interventions (communication between a patient with advanced cancer and their health professional via telehealth technologies), including MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library, Sociological Abstracts, and Web of Science, from the inception of each electronic database up until December 31, 2020. A narrative synthesis was conducted to outline the design, population, and context of the studies. A conceptual framework of digital engagement comprising quantitative behavioral measures (frequency, amount, duration, and depth of use) framed the analysis of engagement with telehealth approaches. Frequency data were transformed to a percentage (actual patient engagement as a proportion of intended engagement), and the interventions were characterized by intensity (high, medium, and low intended engagement) and mode of delivery for standardized comparisons across studies. Results: Of the 19,676 identified papers, 40 (0.2\%) papers covering 39 different studies were eligible for inclusion, dominated by US studies (22/39, 56\%), with most being research studies (26/39, 67\%). The most commonly reported measure of engagement was frequency (36/39, 92\%), with substantial heterogeneity in the way in which it was measured. A standardized percentage of actual patient engagement was derived from 17 studies (17/39, 44\%; n=1255), ranging from 51\% to 100\% with a weighted average of 75.4\% (SD 15.8\%). A directly proportional relationship was found between intervention intensity and actual patient engagement. Higher engagement occurred when a tablet, computer, or smartphone app was the mode of delivery. Conclusions: Understanding engagement for people with advanced cancer can guide the development of telehealth approaches from their design to monitoring as part of routine care. With increasing telehealth use, the development of meaningful and context- and condition-appropriate measures of telehealth engagement is needed to address the current heterogeneity in reporting while improving the understanding of optimal implementation of telehealth for oncology and palliative care. Trial Registration: PROSPERO (International Prospective Register of Systematic Reviews) CRD42018117232; https://www.crd.york.ac.uk/prospero/display\_record.php?ID=CRD42018117232 ", doi="10.2196/33355", url="https://cancer.jmir.org/2022/1/e33355", url="http://www.ncbi.nlm.nih.gov/pubmed/35175205" } @Article{info:doi/10.2196/26414, author="Br{\'e}dart, Anne and Rault, Aude and Terrasson, Johanna and Seigneur, Etienne and De Koning, Leanne and Hess, Elisabeth and Savignoni, Alexia and Cottu, Paul and Pierga, Jean-Yves and Piperno-Neumann, Sophie and Rodrigues, Manuel and Bouleuc, Carole and Dolbeault, Sylvie", title="Helping Patients Communicate With Oncologists When Cancer Treatment Resistance Occurs to Develop, Test, and Implement a Patient Communication Aid: Sequential Collaborative Mixed Methods Study", journal="JMIR Res Protoc", year="2022", month="Jan", day="12", volume="11", number="1", pages="e26414", keywords="cancer resistance", keywords="physician-patient communication", keywords="question prompt list", keywords="patient participation", keywords="collaborative research", keywords="mixed methods", abstract="Background: Most cancer-related deaths result from disseminated diseases that develop resistance to anticancer treatments. Inappropriate communication in this challenging situation may result in unmet patient information and support needs. Patient communication aids such as question prompt lists (QPLs) may help. Objective: This study aims to develop and pilot-test a specific QPL in the following two contrasting clinical contexts in France after cancer resistance has developed: triple-negative and luminal B metastatic breast cancer (MBC) and metastatic uveal melanoma (MUM). Methods: A sequential study design with a mixed methods collaborative approach will be applied. The first step aims to build a specific QPL. Step 1a will explore oncologist-patient communication issues from oncology professionals' interviews (n=20 approximately). Step 1b will appraise information and support needs experienced by patients with MBC or MUM both quantitatively (n=80) and qualitatively (n=40 approximately). These data will be used to develop and pilot-test a QPL specific to patients with cancer experiencing initial or acquired resistance to treatment. We expect to obtain a core QPL that comprises questions and concerns commonly expressed by patients with resistant cancer and is complemented by specific issues for either MBC or MUM cancer sites. In step 1c, 2 focus groups of patients with any type of metastatic cancer (n=4) and health care professionals (n=4) will be conducted to revise the content of a preliminary QPL and elaborate an acceptable and feasible clinical implementation. In step 1d, the content of the QPL version 1 and implementation guidance will be validated using a Delphi process. Step 2 will pilot-test the QPL version 1 in real practice with patients with MBC or MUM (n=80). Clinical utility will be assessed by comparing responses to questionnaires administered in step 1b (QPL-naive historical control group) and step 2 (QPL intervention group). Results: This study received grants in March and December 2019 and was approved by the French national ethics committee in July 2019. As of October 2021, interviews with oncology professionals have been conducted and analyzed (N=26 to reach saturation), and 39 and 27 patients with MBC and MUM, respectively, have been recruited. Conclusions: A clinically and culturally tailored QPL is expected to facilitate patients' participation in consultations, improve oncologists' responses to patients' information and support needs, and thus foster patients' psychological adjustment to the diagnosis and follow-up of cancer resistance to treatment. Trial Registration: ClinicalTrials.gov NCT04118062; http://clinicaltrials.gov/ct2/show/NCT04118062 International Registered Report Identifier (IRRID): DERR1-10.2196/26414 ", doi="10.2196/26414", url="https://www.researchprotocols.org/2022/1/e26414", url="http://www.ncbi.nlm.nih.gov/pubmed/35019850" } @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/10.2196/27886, author="Oerlemans, Simone and Arts, Johanna Lindy Paulina and Kieffer, M. Jacobien and Prins, Judith and Hoogendoorn, Mels and van der Poel, Marjolein and Koster, Ad and Lensen, Chantal and Stevens, Catharina Wendy Bernadina and Issa, Djamila and Pruijt, M. Johannes F. and Oosterveld, Margriet and van der Griend, Ren{\'e} and Nijziel, Marten and Tick, Lidwine and Posthuma, M. Eduardus F. and van de Poll-Franse, V. Lonneke", title="Web-Based Return of Individual Patient-Reported Outcome Results Among Patients With Lymphoma: Randomized Controlled Trial", journal="J Med Internet Res", year="2021", month="Dec", day="14", volume="23", number="12", pages="e27886", keywords="lymphoma", keywords="patient-reported outcomes", keywords="return of individual results", keywords="randomized controlled trial", keywords="self-management", abstract="Background: There has been a cultural shift toward patient engagement in health, with a growing demand from patients to access their results. Objective: The Lymphoma Intervention (LIVE) trial is conducted to examine the impact of return of individual patient-reported outcome (PRO) results and a web-based self-management intervention on psychological distress, self-management, satisfaction with information, and health care use in a population-based setting. Methods: Return of PRO results included comparison with age- and sex-matched peers and was built into the Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship registry. The self-management intervention is an adaptation of a fully automated evidence-based intervention for breast cancer survivors. Patients with lymphoma who completed the web-based questionnaire were equally randomized to care as usual, return of PRO results, and return of PRO results plus self-management intervention. Patients completed questionnaires 9 to 18 months after diagnosis (T0; n=227), 4 months (T1; n=190), 12 months (T2; n=170), and 24 months (T3; n=98). Results: Of all invited patients, 51.1\% (456/892) responded and web-based participants (n=227) were randomly assigned to care as usual (n=76), return of PRO results (n=74), or return of PRO results and access to Living with lymphoma (n=77). Return of PRO results was viewed by 76.7\% (115/150) of those with access. No statistically significant differences were observed for psychological distress, self-management, satisfaction with information provision, and health care use between patients who received PRO results and those who did not (P>.05). Use of the self-management intervention was low (2/76, 3\%), and an effect could therefore not be determined. Conclusions: Return of individual PRO results seems to meet patients' wishes but had no beneficial effects on patient outcome. No negative effects were found when individual PRO results were disclosed, and the return of individual PRO results can therefore be safely implemented in daily clinical practice. Trial Registration: Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-017-1943-2 ", doi="10.2196/27886", url="https://www.jmir.org/2021/12/e27886", url="http://www.ncbi.nlm.nih.gov/pubmed/34904948" } @Article{info:doi/10.2196/23161, author="Grabner, Michael and Molife, Cliff and Wang, Liya and Winfree, B. Katherine and Cui, Lin Zhanglin and Cuyun Carter, Gebra and Hess, M. Lisa", title="Data Integration to Improve Real-world Health Outcomes Research for Non--Small Cell Lung Cancer in the United States: Descriptive and Qualitative Exploration", journal="JMIR Cancer", year="2021", month="Apr", day="12", volume="7", number="2", pages="e23161", keywords="non--small cell lung cancer", keywords="cancer", keywords="data aggregation", keywords="real-world data", keywords="administrative claims data", keywords="medical records", keywords="electronic health record", keywords="retrospective study", keywords="population health", keywords="health services research", abstract="Background: The integration of data from disparate sources could help alleviate data insufficiency in real-world studies and compensate for the inadequacies of single data sources and short-duration, small sample size studies while improving the utility of data for research. Objective: This study aims to describe and evaluate a process of integrating data from several complementary sources to conduct health outcomes research in patients with non--small cell lung cancer (NSCLC). The integrated data set is also used to describe patient demographics, clinical characteristics, treatment patterns, and mortality rates. Methods: This retrospective cohort study integrated data from 4 sources: administrative claims from the HealthCore Integrated Research Database, clinical data from a Cancer Care Quality Program (CCQP), clinical data from abstracted medical records (MRs), and mortality data from the US Social Security Administration. Patients with lung cancer who initiated second-line (2L) therapy between November 01, 2015, and April 13, 2018, were identified in the claims and CCQP data. Eligible patients were 18 years or older and received atezolizumab, docetaxel, erlotinib, nivolumab, pembrolizumab, pemetrexed, or ramucirumab in the 2L setting. The main analysis cohort included patients with claims data and data from at least one additional data source (CCQP or MR). Patients without integrated data (claims only) were reported separately. Descriptive and univariate statistics were reported. Results: Data integration resulted in a main analysis cohort of 2195 patients with NSCLC; 2106 patients had CCQP and 407 patients had MR data. The claims-only cohort included 931 eligible patients. For the main analysis cohort, the mean age was 62.1 (SD 9.27) years, 48.56\% (1066/2195) were female, the median length of follow-up was 6.8 months, and for 37.77\% (829/2195), death was observed. For the claims-only cohort, the mean age was 66.6 (SD 12.69) years, 52.1\% (485/931) were female, the median length of follow-up was 8.6 months, and for 29.3\% (273/931), death was observed. The most frequent 2L treatment was immunotherapy (1094/2195, 49.84\%), followed by platinum-based regimens (472/2195, 21.50\%) and single-agent chemotherapy (441/2195, 20.09\%); mean duration of 2L therapy was 5.6 (SD 4.9, median 4) months. We describe challenges and learnings from the data integration process, and the benefits of the integrated data set, which includes a richer set of clinical and outcome data to supplement the utilization metrics available in administrative claims. Conclusions: The management of patients with NSCLC requires care from a multidisciplinary team, leading to a lack of a single aggregated data source in real-world settings. The availability of integrated clinical data from MRs, health plan claims, and other sources of clinical care may improve the ability to assess emerging treatments. ", doi="10.2196/23161", url="https://cancer.jmir.org/2021/2/e23161", url="http://www.ncbi.nlm.nih.gov/pubmed/33843600" } @Article{info:doi/10.2196/18269, author="Ma, Jinfei and Zou, Zihao and Pazo, Eric Emmanuel and Moutari, Salissou and Liu, Ye and Jin, Feng", title="Comparative Analysis of Paper-Based and Web-Based Versions of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16) Questionnaire in Breast Cancer Patients: Randomized Crossover Study", journal="JMIR Med Inform", year="2021", month="Mar", day="2", volume="9", number="3", pages="e18269", keywords="breast cancer", keywords="NFBSI-16", keywords="patient-reported outcome", keywords="reproducibility", keywords="test-retest reliability", keywords="web-based questionnaire", abstract="Background: Breast cancer remains the most common neoplasm diagnosed among women in China and globally. Health-related questionnaire assessments in research and clinical oncology settings have gained prominence. The National Comprehensive Cancer Network--Functional Assessment of Cancer Therapy--Breast Cancer Symptom Index (NFBSI-16) is a rapid and powerful tool to help evaluate disease- or treatment-related symptoms, both physical and emotional, in patients with breast cancer for clinical and research purposes. Prevalence of individual smartphones provides a potential web-based approach to administrating the questionnaire; however, the reliability of the NFBSI-16 in electronic format has not been assessed. Objective: This study aimed to assess the reliability of a web-based NFBSI-16 questionnaire in breast cancer patients undergoing systematic treatment with a prospective open-label randomized crossover study design. Methods: We recruited random patients with breast cancer under systematic treatment from the central hospital registry to complete both paper- and web-based versions of the questionnaires. Both versions of the questionnaires were self-assessed. Patients were randomly assigned to group A (paper-based first and web-based second) or group B (web-based first and paper-based second). A total of 354 patients were included in the analysis (group A: n=177, group B: n=177). Descriptive sociodemographic characteristics, reliability and agreement rates for single items, subscales, and total score were analyzed using the Wilcoxon test. The Lin concordance correlation coefficient (CCC) and Spearman and Kendall $\tau$ rank correlations were used to assess test-retest reliability. Results: Test-retest reliability measured with CCCs was 0.94 for the total NFBSI-16 score. Significant correlations (Spearman $\rho$) were documented for all 4 subscales---Disease-Related Symptoms Subscale--Physical ($\rho$=0.93), Disease-Related Symptoms Subscale--Emotional ($\rho$=0.85), Treatment Side Effects Subscale ($\rho$=0.95), and Function and Well-Being Subscale ($\rho$=0.91)---and total NFBSI-16 score ($\rho$=0.94). Mean differences of the test and retest were all close to zero (?0.06). The parallel test-retest reliability of subscales with the Wilcoxon test comparing individual items found GP3 (item 5) to be significantly different (P=.02). A majority of the participants in this study (255/354, 72.0\%) preferred the web-based over the paper-based version. Conclusions: The web-based version of the NFBSI-16 questionnaire is an excellent tool for monitoring individual breast cancer patients under treatment, with the majority of participants preferring it over the paper-based version. ", doi="10.2196/18269", url="https://medinform.jmir.org/2021/3/e18269", url="http://www.ncbi.nlm.nih.gov/pubmed/33650978" } @Article{info:doi/10.2196/21238, author="Sungur, Hande and Y?lmaz, Gizem Nida and Chan, Chu Brittany Ming and van den Muijsenbergh, C. Maria E. T. and van Weert, M. Julia C. and Schouten, C. Barbara", title="Development and Evaluation of a Digital Intervention for Fulfilling the Needs of Older Migrant Patients With Cancer: User-Centered Design Approach", journal="J Med Internet Res", year="2020", month="Oct", day="26", volume="22", number="10", pages="e21238", keywords="cancer", keywords="patient participation", keywords="health services needs and demand", keywords="eHealth", keywords="migrants", keywords="physician-patient relations", keywords="culture", keywords="mobile phone", abstract="Background: Older migrant patients with cancer face many language- and culture-related barriers to patient participation during medical consultations. To bridge these barriers, an eHealth tool called Health Communicator was developed in the Netherlands. Essentially used as a digital translator that can collect medical history information from patients, the Health Communicator did not include an oncological module so far, despite the fact that the prevalence of Dutch migrant patients with cancer is rising. Objective: This study aims to systematically develop, implement, and conduct a pilot evaluation of an oncological module that can be integrated into the Health Communicator to stimulate patient participation among older Turkish-Dutch and Moroccan-Dutch patients with cancer. Methods: The Spiral Technology Action Research model, which incorporates 5 cycles that engage key stakeholders in intervention development, was used as a framework. The listen phase consisted of a needs assessment. The plan phase consisted of developing the content of the oncological module, namely the question prompt lists (QPLs) and scripts for patient education videos. On the basis of pretests in the do phase, 6 audiovisual QPLs on patient rights, treatment, psychosocial support, lifestyle and access to health care services, patient preferences, and clinical trials were created. Additionally, 5 patient education videos were created about patient rights, psychosocial support, clinical trials, and patient-professional communication. In the study phase, the oncological module was pilot-tested among 27 older Turkish-Dutch and Moroccan-Dutch patients with cancer during their consultations. In the act phase, the oncological model was disseminated to practice. Results: The patient rights QPL was chosen most often during the pilot testing in the study phase. Patients and health care professionals perceived the QPLs as easy to understand and useful. There was a negative correlation between the tool's ease of use and patient age. Patients reported that using the module impacted the consultations positively and thought they were more active compared with previous consultations. Health care professionals also found patients to be more active than usual. Health care professionals asked significantly more questions than patients during consultations. Patients requested to see the patients' rights video most often. Patients rated the videos as easy to understand, useful, and informative. Most of the patients wanted to use the tool in the future. Conclusions: Older migrant patients with cancer, survivors, and health care professionals found the oncological module to be a useful tool and have shown intentions to incorporate it into future consultation sessions. Both QPLs and videos were evaluated positively, the latter indicating that the use of narratives to inform older, low-literate migrant patients with cancer about health-related topics in their mother tongue is a viable approach to increase the effectiveness of health care communication with this target group. ", doi="10.2196/21238", url="http://www.jmir.org/2020/10/e21238/", url="http://www.ncbi.nlm.nih.gov/pubmed/33104008" } @Article{info:doi/10.2196/15911, author="Abdulaal, Ahmed and Arhi, Chanpreet and Ziprin, Paul", title="Effect of Health Care Provider Delays on Short-Term Outcomes in Patients With Colorectal Cancer: Multicenter Population-Based Observational Study", journal="Interact J Med Res", year="2020", month="Jul", day="17", volume="9", number="3", pages="e15911", keywords="surgery", keywords="cancer", keywords="colorectal", keywords="delay", abstract="Background: The United Kingdom has lower survival figures for all types of cancers compared to many European countries despite similar national expenditures on health. This discrepancy may be linked to long diagnostic and treatment delays. Objective: The aim of this study was to determine whether delays experienced by patients with colorectal cancer (CRC) affect their survival. Methods: This observational study utilized the Somerset Cancer Register to identify patients with CRC who were diagnosed on the basis of positive histology findings. The effects of diagnostic and treatment delays and their subdivisions on outcomes were investigated using Cox proportional hazards regression. Kaplan-Meier plots were used to illustrate group differences. Results: A total of 648 patients (375 males, 57.9\% males) were included in this study. We found that neither diagnostic delay nor treatment delay had an effect on the overall survival in patients with CRC ($\chi$23=1.5, P=.68; $\chi$23=0.6, P=.90, respectively). Similarly, treatment delays did not affect the outcomes in patients with CRC ($\chi$23=5.5, P=.14). The initial Cox regression analysis showed that patients with CRC who had short diagnostic delays were less likely to die than those experiencing long delays (hazard ratio 0.165, 95\% CI 0.044-0.616; P=.007). However, this result was nonsignificant following sensitivity analysis. Conclusions: Diagnostic and treatment delays had no effect on the survival of this cohort of patients with CRC. The utility of the 2-week wait referral system is therefore questioned. Timely screening with subsequent early referral and access to diagnostics may have a more beneficial effect. ", doi="10.2196/15911", url="https://www.i-jmr.org/2020/3/e15911", url="http://www.ncbi.nlm.nih.gov/pubmed/32706666" }