TY - JOUR AU - Kuerbanjiang, Warisijiang AU - Peng, Shengzhe AU - Jiamaliding, Yiershatijiang AU - Yi, Yuexiong PY - 2025/2/5 TI - Performance Evaluation of Large Language Models in Cervical Cancer Management Based on a Standardized Questionnaire: Comparative Study JO - J Med Internet Res SP - e63626 VL - 27 KW - large language model KW - cervical cancer KW - screening KW - artificial intelligence KW - model interpretability N2 - Background: Cervical cancer remains the fourth leading cause of death among women globally, with a particularly severe burden in low-resource settings. A comprehensive approach?from screening to diagnosis and treatment?is essential for effective prevention and management. Large language models (LLMs) have emerged as potential tools to support health care, though their specific role in cervical cancer management remains underexplored. Objective: This study aims to systematically evaluate the performance and interpretability of LLMs in cervical cancer management. Methods: Models were selected from the AlpacaEval leaderboard version 2.0 and based on the capabilities of our computer. The questions inputted into the models cover aspects of general knowledge, screening, diagnosis, and treatment, according to guidelines. The prompt was developed using the Context, Objective, Style, Tone, Audience, and Response (CO-STAR) framework. Responses were evaluated for accuracy, guideline compliance, clarity, and practicality, graded as A, B, C, and D with corresponding scores of 3, 2, 1, and 0. The effective rate was calculated as the ratio of A and B responses to the total number of designed questions. Local Interpretable Model-Agnostic Explanations (LIME) was used to explain and enhance physicians? trust in model outputs within the medical context. Results: Nine models were included in this study, and a set of 100 standardized questions covering general information, screening, diagnosis, and treatment was designed based on international and national guidelines. Seven models (ChatGPT-4.0 Turbo, Claude 2, Gemini Pro, Mistral-7B-v0.2, Starling-LM-7B alpha, HuatuoGPT, and BioMedLM 2.7B) provided stable responses. Among all the models included, ChatGPT-4.0 Turbo ranked first with a mean score of 2.67 (95% CI 2.54-2.80; effective rate 94.00%) with a prompt and 2.52 (95% CI 2.37-2.67; effective rate 87.00%) without a prompt, outperforming the other 8 models (P<.001). Regardless of prompts, QiZhenGPT consistently ranked among the lowest-performing models, with P<.01 in comparisons against all models except BioMedLM. Interpretability analysis showed that prompts improved alignment with human annotations for proprietary models (median intersection over union 0.43), while medical-specialized models exhibited limited improvement. Conclusions: Proprietary LLMs, particularly ChatGPT-4.0 Turbo and Claude 2, show promise in clinical decision-making involving logical analysis. The use of prompts can enhance the accuracy of some models in cervical cancer management to varying degrees. Medical-specialized models, such as HuatuoGPT and BioMedLM, did not perform as well as expected in this study. By contrast, proprietary models, particularly those augmented with prompts, demonstrated notable accuracy and interpretability in medical tasks, such as cervical cancer management. However, this study underscores the need for further research to explore the practical application of LLMs in medical practice. UR - https://www.jmir.org/2025/1/e63626 UR - http://dx.doi.org/10.2196/63626 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63626 ER - TY - JOUR AU - Geeraerts, Joran AU - Pivodic, Lara AU - Rosquin, Lise AU - Naert, Eline AU - Crombez, Geert AU - De Ridder, Mark AU - Van den Block, Lieve PY - 2024/11/5 TI - Uncovering the Daily Experiences of People Living With Advanced Cancer Using an Experience Sampling Method Questionnaire: Development, Content Validation, and Optimization Study JO - JMIR Cancer SP - e57510 VL - 10 KW - cancer KW - quality of life KW - ecological momentary assessment KW - experience sampling method KW - telemedicine KW - mHealth KW - eHealth KW - patient outcome assessment KW - validated instruments N2 - Background: The experience sampling method (ESM), a self-report method that typically uses multiple assessments per day, can provide detailed knowledge of the daily experiences of people with cancer, potentially informing oncological care. The use of the ESM among people with advanced cancer is limited, and no validated ESM questionnaires have been developed specifically for oncology. Objective: This study aims to develop, content validate, and optimize the digital Experience Sampling Method for People Living With Advanced Cancer (ESM-AC) questionnaire, covering multidimensional domains and contextual factors. Methods: A 3-round mixed methods study was designed in accordance with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) and the European Organization for Research and Treatment of Cancer guidelines. The study included semistructured interviews with 43 people with stage IV breast cancer or stage III to IV lung cancer and 8 health care professionals. Round 1 assessed the appropriateness, relative importance, relevance, and comprehensiveness of an initial set of ESM items that were developed based on the existing questionnaires. Round 2 tested the comprehensibility of ESM items. Round 3 tested the usability of the digital ESM-AC questionnaire using the m-Path app. Analyses included descriptive statistics and qualitative content analysis. Results: Following the first round, we developed an initial core set of 68 items (to be used with all patients) and a supplementary set (optional; patients select items), both covering physical, psychological, social, spiritual-existential, and global well-being domains and concurrent contexts in which experiences occur. We categorized items to be assessed multiple times per day as momentary items (eg, ?At this moment, I feel tired?), once a day in the morning as morning items (eg, ?Last night, I slept well?), or once a day in the evening as evening items (eg, ?Today, I felt hopeful?). We used participants? evaluations to optimize the questionnaire items, the digital app, and its onboarding manual. This resulted in the ESM-AC questionnaire, which comprised a digital core questionnaire containing 31 momentary items, 2 morning items, and 7 evening items and a supplementary set containing 39 items. Participants largely rated the digital questionnaire as ?easy to use,? with an average score of 4.5 (SD 0.5) on a scale from 1 (?completely disagree?) to 5 (?completely agree?). Conclusions: We developed the ESM-AC questionnaire, a content-validated digital questionnaire for people with advanced breast or lung cancer. It showed good usability when administered on smartphone devices. Future research should evaluate the potential of this ESM tool to uncover daily experiences of people with advanced breast or lung cancer, explore its clinical utility, and extend its validation to other populations with advanced diseases. UR - https://cancer.jmir.org/2024/1/e57510 UR - http://dx.doi.org/10.2196/57510 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/57510 ER - TY - JOUR AU - Jia, Yan AU - Li, Qi AU - Zhang, Xiaowen AU - Yan, Yi AU - Yan, Shiyan AU - Li, Shunping AU - Li, Wei AU - Wu, Xiaowen AU - Rong, Hongguo AU - Liu, Jianping PY - 2024/5/8 TI - Application of Patient-Reported Outcome Measurements in Adult Tumor Clinical Trials in China: Cross-Sectional Study JO - J Med Internet Res SP - e45719 VL - 26 KW - patient-reported outcomes KW - tumor KW - cross-sectional study KW - quality of life KW - outcome study N2 - Background: International health policies and researchers have emphasized the value of evaluating patient-reported outcomes (PROs) in clinical studies. However, the characteristics of PROs in adult tumor clinical trials in China remain insufficiently elucidated. Objective: This study aims to assess the application and characteristics of PRO instruments as primary or secondary outcomes in adult randomized clinical trials related to tumors in China. Methods: This cross-sectional study identified tumor-focused randomized clinical trials conducted in China between January 1, 2010, and June 30, 2022. The ClinicalTrials.gov database and the Chinese Clinical Trial Registry were selected as the databases. Trials were classified into four groups based on the use of PRO instruments: (1) trials listing PRO instruments as primary outcomes, (2) trials listing PRO instruments as secondary outcomes, (3) trials listing PRO instruments as coprimary outcomes, and (4) trials without any mention of PRO instruments. Pertinent data, including study phase, settings, geographic regions, centers, participant demographics (age and sex), funding sources, intervention types, target diseases, and the names of PRO instruments, were extracted from these trials. The target diseases involved in the trials were grouped according to the American Joint Committee on Cancer Staging Manual, 8th Edition. Results: Among the 6445 trials examined, 2390 (37.08%) incorporated PRO instruments as part of their outcomes. Within this subset, 26.82% (641/2390) listed PRO instruments as primary outcomes, 52.72% (1260/2390) as secondary outcomes, and 20.46% (489/2390) as coprimary outcomes. Among the 2,155,306 participants included in these trials, PRO instruments were used to collect data from 613,648 (28.47%) patients as primary or secondary outcomes and from 74,287 (3.45%) patients as coprimary outcomes. The most common conditions explicitly using specified PRO instruments included thorax tumors (217/1280, 16.95%), breast tumors (176/1280, 13.75%), and lower gastrointestinal tract tumors (173/1280, 13.52%). Frequently used PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire?30, the visual analog scale, the numeric rating scale, the Traditional Chinese Medicine Symptom Scale, and the Pittsburgh Sleep Quality Index. Conclusions: Over recent years, the incorporation of PROs has demonstrated an upward trajectory in adult randomized clinical trials on tumors in China. Nonetheless, the infrequent measurement of the patient?s voice remains noteworthy. Disease-specific PRO instruments should be more effectively incorporated into various tumor disease categories in clinical trials, and there is room for improvement in the inclusion of PRO instruments as clinical trial end points. UR - https://www.jmir.org/2024/1/e45719 UR - http://dx.doi.org/10.2196/45719 UR - http://www.ncbi.nlm.nih.gov/pubmed/38718388 ID - info:doi/10.2196/45719 ER - TY - JOUR AU - Spooner, Caitlin AU - Vivat, Bella AU - White, Nicola AU - Stone, Patrick PY - 2023/9/1 TI - Developing a Core Outcome Set for Prognostic Research in Palliative Cancer Care: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e49774 VL - 12 KW - core outcome set KW - palliative care KW - end-of-life KW - prognosis KW - advanced cancer KW - systematic review KW - interviews KW - Delphi study N2 - Background: Studies exploring the impact of receiving end-of-life prognoses in patients with advanced cancer use a variety of different measures to evaluate the outcomes, and thus report often conflicting findings. The standardization of outcomes reported in studies of prognostication in palliative cancer care could enable uniform assessment and reporting, as well as intertrial comparisons. A core outcome set promotes consistency in outcome selection and reporting among studies within a particular population. We aim to develop a set of core outcomes to be used to measure the impact of end-of-life prognostication in palliative cancer care. Objective: This protocol outlines the proposed methodology to develop a core outcome set for measuring the impact of end-of-life prognostication in palliative cancer care. Methods: We will adopt a mixed methods approach consisting of 3 phases using methodology recommended by the Core Outcome Measure in Effectiveness Trials (COMET) initiative. In phase I, we will conduct a systematic review to identify existing outcomes that prognostic studies have previously used, so as to inform the development of items and domains for the proposed core outcome set. Phase II will consist of semistructured interviews with patients with advanced cancer who are receiving palliative care, informal caregivers, and clinicians, to explore their perceptions and experiences of end-of-life prognostication. Outcomes identified in the interviews will be combined with those found in existing literature and taken forward to phase III, a Delphi survey, in which we will ask patients, informal caregivers, clinicians, and relevant researchers to rate these outcomes until consensus is achieved as to which are considered to be the most important for inclusion in the core outcome set. The resulting, prioritized outcomes will be discussed in a consensus meeting to agree and endorse the final core outcome set. Results: Ethical approval was received for this study in September 2022. As of July 2023, we have completed and published the systematic review (phase I) and have started recruitment for phase II. Data analysis for phase II has not yet started. We expect to complete the study by October 2024. Conclusions: This protocol presents the stepwise approach that will be taken to develop a core outcome set for measuring the impact of end-of-life prognostication in palliative cancer care. The final core outcome set has the potential for translation into clinical practice, allowing for consistent evaluation of emerging prognostic algorithms and improving communication of end-of-life prognostication. This study will also potentially facilitate the design of future clinical trials of the impact of end-of-life prognostication in palliative care that are acceptable to key stakeholders. Trial Registration: Core Outcome Measures in Effectiveness Trials 2136; https://www.comet-initiative.org/Studies/Details/2136 International Registered Report Identifier (IRRID): DERR1-10.2196/49774 UR - https://www.researchprotocols.org/2023/1/e49774 UR - http://dx.doi.org/10.2196/49774 UR - http://www.ncbi.nlm.nih.gov/pubmed/37656505 ID - info:doi/10.2196/49774 ER - TY - JOUR AU - Griffin-Mathieu, Gabrielle AU - Haward, Ben AU - Tatar, Ovidiu AU - Zhu, Patricia AU - Perez, Samara AU - Shapiro, K. Gilla AU - McBride, Emily AU - Thompson, L. Erika AU - Smith, W. Laurie AU - Lofters, K. Aisha AU - Daley, M. Ellen AU - Guichon, R. Juliet AU - Waller, Jo AU - Steben, Marc AU - Decker, M. Kathleen AU - Mayrand, Marie-Helene AU - Brotherton, L. Julia M. AU - Ogilvie, S. Gina AU - Zimet, D. Gregory AU - Norris, Teresa AU - Rosberger, Zeev PY - 2022/6/16 TI - Ensuring a Successful Transition From Cytology to Human Papillomavirus?Based Primary Cervical Cancer Screening in Canada by Investigating the Psychosocial Correlates of Women?s Intentions: Protocol for an Observational Study JO - JMIR Res Protoc SP - e38917 VL - 11 IS - 6 KW - human papillomavirus KW - HPV-based primary screening KW - cervical cancer KW - cervical cancer screening KW - cancer prevention KW - knowledge KW - attitudes and beliefs KW - preferences KW - HPV test acceptability KW - HPV self-sampling KW - Pap testing KW - cytology KW - mobile phone N2 - Background: The human papillomavirus (HPV) test has emerged as a significant improvement over cytology for primary cervical cancer screening. In Canada, provinces and territories are moving toward implementing HPV testing in cervical cancer screening programs. Although an abundance of research exists on the benefits of HPV-based screening, there is a dearth of research examining women?s understanding of HPV testing. In other countries, failure to adequately address women?s concerns about changes has disrupted the implementation of HPV-based screening. Objective: The aims of the multipart study described in this paper are to develop psychometrically valid measures of cervical cancer screening?related knowledge, attitudes, and beliefs; to examine the feasibility of a questionnaire examining psychosocial factors related to HPV-based screening; and to investigate psychosocial correlates of women?s intentions to participate in HPV-based screening. Methods: We conducted a web-based survey (study 1) of Canadian women to assess the acceptability and feasibility of a questionnaire, including the validation of scales examining cervical cancer knowledge, HPV testing knowledge, HPV testing attitudes and beliefs, and HPV test self-sampling attitudes and beliefs. Preferences for cervical cancer screening were assessed using the best-worst scaling methodology. A second web-based survey (study 2) will be administered to a national sample of Canadian women between June 2022 and July 2022 using the validated scales. Differences in the knowledge, attitudes, beliefs, and preferences of women who are currently either underscreened or adequately screened for cervical cancer will be examined through bivariate analyses. Multinomial logistic regression will be used to estimate the associations between psychosocial and sociodemographic factors and intentions to undergo HPV-based screening. Results: Between October 2021 and November 2021, a total of 1230 participants completed the questionnaire in study 1, and 1027 (83.49%) responses were retained after data cleaning methods were applied. Feasibility was comparable with similar population-based surveys in terms of survey length, participant attrition, and the number of participants excluded after data cleaning. As of May 2022, analysis of study 1 is ongoing, and results are expected to be published in the summer of 2022. Data collection is expected to begin for study 2 in the summer of 2022. Results are expected to be published between late 2022 and early 2023. Conclusions: Findings will provide direction for Canadian public health authorities to align guidelines to address women?s concerns and optimize the acceptability and uptake of HPV-based primary screening. Validated scales can be used by other researchers to improve and standardize the measurement of psychosocial factors affecting HPV test acceptability. Study results will be disseminated through peer-reviewed journal articles; conference presentations; and direct communication with researchers, clinicians, policy makers, media, and specialty organizations. International Registered Report Identifier (IRRID): DERR1-10.2196/38917 UR - https://www.researchprotocols.org/2022/6/e38917 UR - http://dx.doi.org/10.2196/38917 UR - http://www.ncbi.nlm.nih.gov/pubmed/35708742 ID - info:doi/10.2196/38917 ER - TY - JOUR AU - Oerlemans, Simone AU - Arts, Johanna Lindy Paulina AU - Kieffer, M. Jacobien AU - Prins, Judith AU - Hoogendoorn, Mels AU - van der Poel, Marjolein AU - Koster, Ad AU - Lensen, Chantal AU - Stevens, Catharina Wendy Bernadina AU - Issa, Djamila AU - Pruijt, M. Johannes F. AU - Oosterveld, Margriet AU - van der Griend, René AU - Nijziel, Marten AU - Tick, Lidwine AU - Posthuma, M. Eduardus F. AU - van de Poll-Franse, V. Lonneke PY - 2021/12/14 TI - Web-Based Return of Individual Patient-Reported Outcome Results Among Patients With Lymphoma: Randomized Controlled Trial JO - J Med Internet Res SP - e27886 VL - 23 IS - 12 KW - lymphoma KW - patient-reported outcomes KW - return of individual results KW - randomized controlled trial KW - self-management N2 - 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 UR - https://www.jmir.org/2021/12/e27886 UR - http://dx.doi.org/10.2196/27886 UR - http://www.ncbi.nlm.nih.gov/pubmed/34904948 ID - info:doi/10.2196/27886 ER - TY - JOUR AU - Steeb, Theresa AU - Heppt, V. Markus AU - Erdmann, Michael AU - Wessely, Anja AU - Klug, J. Stefanie AU - Berking, Carola PY - 2021/12/13 TI - Increasing Participation Rates in Germany?s Skin Cancer Screening Program (HELIOS): Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e31860 VL - 10 IS - 12 KW - skin cancer KW - melanoma KW - squamous cell carcinoma KW - basal cell carcinoma KW - screening KW - early detection KW - focus group KW - mixed methods KW - cross-sectional study KW - prevention N2 - Background: In 2008, a nationwide skin cancer screening (SCS) program was implemented in Germany. However, participation rates remain low. Objective: The overall objective of the HELIOS study is to identify subgroup-specific invitation and communication strategies to increase informed SCS participation in Germany. Methods: Focus group discussions will be performed in Erlangen, Germany, to explore potential invitation and communication strategies as well as possible barriers and motivating factors to participate in SCS. Male and female patients of different age groups who have already been diagnosed with skin cancer, as well as participants without a prior diagnosis of skin cancer, will be invited. Based on these results, an online questionnaire will be developed to identify subgroup-specific invitation strategies. A random sample of 2500 persons from the general population aged >35 years from the Munich area will be contacted to complete the questionnaire. Besides descriptive analysis, multinomial logistic regression will be performed. Additionally, a cluster analysis will be conducted to discover patterns or similarities among the participants. Results: Recruitment for the focus group studies started in February 2021 and is ongoing. As of August 2021, we have enrolled 39 participants. We expect to end enrollment in the qualitative study in September 2021 and to finish the analysis in December 2021. The second part of the study will then start in January 2022. Conclusions: The results of this project will enable us to derive improved and more efficient invitation and communication strategies for SCS. These may be implemented in the future to facilitate increased SCS uptake and early skin cancer detection. International Registered Report Identifier (IRRID): DERR1-10.2196/31860 UR - https://www.researchprotocols.org/2021/12/e31860 UR - http://dx.doi.org/10.2196/31860 UR - http://www.ncbi.nlm.nih.gov/pubmed/34898465 ID - info:doi/10.2196/31860 ER - TY - JOUR AU - Wright, Hayley AU - Martin, Faith AU - Clyne, Wendy AU - Clark, T. Cain C. AU - Matouskova, Gabriela AU - McGillion, Michael AU - Turner, Andrew PY - 2021/11/5 TI - A Digital Self-management Program (Help to Overcome Problems Effectively) for People Living With Cancer: Feasibility Randomized Controlled Trial JO - J Med Internet Res SP - e28322 VL - 23 IS - 11 KW - self-management KW - cancer KW - survivorship KW - digital KW - positive psychology N2 - Background: We present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer. Objective: This study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context. Methods: Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants? positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web. Results: The recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ?3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session. Conclusions: All progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG. Trial Registration: ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID): RR2-10.2196/24264 UR - https://www.jmir.org/2021/11/e28322 UR - http://dx.doi.org/10.2196/28322 UR - http://www.ncbi.nlm.nih.gov/pubmed/34738912 ID - info:doi/10.2196/28322 ER - TY - JOUR AU - Brusniak, Katharina AU - Feisst, Manuel AU - Sebesteny, Linda AU - Hartkopf, Andreas AU - Graf, Joachim AU - Engler, Tobias AU - Schneeweiss, Andreas AU - Wallwiener, Markus AU - Deutsch, Maximilian Thomas PY - 2021/10/12 TI - Measuring the Time to Deterioration for Health-Related Quality of Life in Patients With Metastatic Breast Cancer Using a Web-Based Monitoring Application: Longitudinal Cohort Study JO - JMIR Cancer SP - e25776 VL - 7 IS - 4 KW - eHealth KW - breast cancer KW - health-related quality of life KW - quality of life KW - time to deterioration KW - EQ-VAS KW - EQ-5D-5L KW - EORTC QLQ-C30 N2 - Background: Health-related quality of life (HRQoL) is used to evaluate the treatment of metastatic breast cancer. In a long-term therapy setting, HRQoL can be used as an important benchmark for treatment success. With the help of digital apps, HRQoL monitoring can be extended to more remote areas and be administered on a more frequent basis. Objective: This study aims to evaluate 3 common HRQoL questionnaires in metastasized breast cancer in terms of TTD in a digital, web-based setting. We further aim to examine the development of the HRQoL in different systemic treatment groups in each of these evaluation instruments. Methods: A total of 192 patients with metastatic breast cancer were analyzed in this bicentric prospective online cohort study at two German university hospitals. Patients completed questionnaires on HRQoL (EuroQol Visual Analog Scale [EQ-VAS], EuroQol 5 Dimension 5 Level [EQ-5D-5L], European Organization for Research and Treatment of Cancer Quality of Life Questionnaire?Core 30 item [EORTC QLQ-C30]) via an online platform over a 6-month period. Treatment schedules and medical history were retrieved from medical records. Unadjusted Cox regression analysis on treatment-related factors was performed. We conducted subgroup analyses in regard to TTD events between different treatments. Results: The EQ-VAS showed a higher rate of deterioration after 8 weeks (84/179, 46.9%) than the EQ-5D-5L (47/163, 28.8%) and EORTC QLQ-C30 (65/176, 36.9%). Unadjusted Cox regression revealed significant connections between known metastases in the liver (P=.03, HR 1.64, 95% CI 1.06-2.52) and pleura (P=.04, HR 0.42, 95% CI 0.18-0.96) in the EQ-VAS. Significant relations between EQ-VAS events and single EQ-5D-5L items and the EQ-5D-5L summary score were demonstrated. All treatment groups significantly differed from the CDK4/6 inhibition subgroup in the EQ-VAS. Conclusions: Compared to the EQ-5D-5L and QLQ-C30, the EQ-VAS showed a higher rate of deterioration after 8 weeks. Significant connections to certain metastatic locations were only detected in the EQ-VAS. The EQ-VAS is capable of reflecting the distinctive HRQoL profiles of different systemic treatments as well as the different aspects of HRQoL presented in the EQ-5D-5L. TTD with the EQ-VAS is an adequate mean of examining longitudinal development of HRQoL among breast cancer patients. UR - https://cancer.jmir.org/2021/4/e25776 UR - http://dx.doi.org/10.2196/25776 UR - http://www.ncbi.nlm.nih.gov/pubmed/34636732 ID - info:doi/10.2196/25776 ER - TY - JOUR AU - Naeim, Arash AU - Dry, Sarah AU - Elashoff, David AU - Xie, Zhuoer AU - Petruse, Antonia AU - Magyar, Clara AU - Johansen, Liliana AU - Werre, Gabriela AU - Lajonchere, Clara AU - Wenger, Neil PY - 2021/9/8 TI - Electronic Video Consent to Power Precision Health Research: A Pilot Cohort Study JO - JMIR Form Res SP - e29123 VL - 5 IS - 9 KW - biobanking KW - precision medicine KW - electronic consent KW - privacy KW - pilot study KW - video KW - consent KW - precision KW - innovation KW - efficient KW - cancer KW - education KW - barrier KW - engagement KW - participation N2 - Background: Developing innovative, efficient, and institutionally scalable biospecimen consent for remnant tissue that meets the National Institutes of Health consent guidelines for genomic and molecular analysis is essential for precision medicine efforts in cancer. Objective: This study aims to pilot-test an electronic video consent that individuals could complete largely on their own. Methods: The University of California, Los Angeles developed a video consenting approach designed to be comprehensive yet fast (around 5 minutes) for providing universal consent for remnant biospecimen collection for research. The approach was piloted in 175 patients who were coming in for routine services in laboratory medicine, radiology, oncology, and hospital admissions. The pilot yielded 164 completed postconsent surveys. The pilot assessed the usefulness, ease, and trustworthiness of the video consent. In addition, we explored drivers for opting in or opting out. Results: The pilot demonstrated that the electronic video consent was well received by patients, with high scores for usefulness, ease, and trustworthiness even among patients that opted out of participation. The revised more animated video pilot test in phase 2 was better received in terms of ease of use (P=.005) and the ability to understand the information (P<.001). There were significant differences between those who opted in and opted out in their beliefs concerning the usefulness of tissue, trusting researchers, the importance of contributing to science, and privacy risk (P<.001). The results showed that ?I trust researchers to use leftover biological specimens to promote the public?s health? and ?Sharing a biological sample for research is safe because of the privacy protections in place? discriminated opt-in statuses were the strongest predictors (both areas under the curve were 0.88). Privacy concerns seemed universal in individuals who opted out. Conclusions: Efforts to better educate the community may be needed to help overcome some of the barriers in engaging individuals to participate in precision health initiatives. UR - https://formative.jmir.org/2021/9/e29123 UR - http://dx.doi.org/10.2196/29123 UR - http://www.ncbi.nlm.nih.gov/pubmed/34313247 ID - info:doi/10.2196/29123 ER - TY - JOUR AU - Trojan, Andreas AU - Leuthold, Nicolas AU - Thomssen, Christoph AU - Rody, Achim AU - Winder, Thomas AU - Jakob, Andreas AU - Egger, Claudine AU - Held, Ulrike AU - Jackisch, Christian PY - 2021/8/5 TI - The Effect of Collaborative Reviews of Electronic Patient-Reported Outcomes on the Congruence of Patient- and Clinician-Reported Toxicity in Cancer Patients Receiving Systemic Therapy: Prospective, Multicenter, Observational Clinical Trial JO - J Med Internet Res SP - e29271 VL - 23 IS - 8 KW - cancer KW - consilium KW - app KW - eHealth KW - ePRO KW - CTCAE KW - congruency KW - patient-reported KW - symptoms N2 - Background: Electronic patient-reported outcomes (ePRO) are a relatively novel form of data and have the potential to improve clinical practice for cancer patients. In this prospective, multicenter, observational clinical trial, efforts were made to demonstrate the reliability of patient-reported symptoms. Objective: The primary objective of this study was to assess the level of agreement ? between symptom ratings by physicians and patients via a shared review process in order to determine the future reliability and utility of self-reported electronic symptom monitoring. Methods: Patients receiving systemic therapy in a (neo-)adjuvant or noncurative intention setting captured ePRO for 52 symptoms over an observational period of 90 days. At 3-week intervals, randomly selected symptoms were reviewed between the patient and physician for congruency on severity of the grading of adverse events according to the Common Terminology Criteria of Adverse Events (CTCAE). The patient-physician agreement for the symptom review was assessed via Cohen kappa (?), through which the interrater reliability was calculated. Chi-square tests were used to determine whether the patient-reported outcome was different among symptoms, types of cancer, demographics, and physicians? experience. Results: Among the 181 patients (158 women and 23 men; median age 54.4 years), there was a fair scoring agreement (?=0.24; 95% CI 0.16-0.33) for symptoms that were entered 2 to 4 weeks before the intended review (first rating) and a moderate agreement (?=0.41; 95% CI 0.34-0.48) for symptoms that were entered within 1 week of the intended review (second rating). However, the level of agreement increased from moderate (first rating, ?=0.43) to substantial (second rating, ?=0.68) for common symptoms of pain, fever, diarrhea, obstipation, nausea, vomiting, and stomatitis. Similar congruency levels of ratings were found for the most frequently entered symptoms (first rating: ?=0.42; second rating: ?=0.65). The symptom with the lowest agreement was hair loss (?=?0.05). With regard to the latency of symptom entry into the review, hardly any difference was demonstrated between symptoms that were entered from days 1 to 3 and from days 4 to 7 before the intended review (?=0.40 vs ?=0.39, respectively). In contrast, for symptoms that were entered 15 to 21 days before the intended review, no congruency was demonstrated (?=?0.15). Congruency levels seemed to be unrelated to the type of cancer, demographics, and physicians? review experience. Conclusions: The shared monitoring and review of symptoms between patients and clinicians has the potential to improve the understanding of patient self-reporting. Our data indicate that the integration of ePRO into oncological clinical research and continuous clinical practice provides reliable information for self-empowerment and the timely intervention of symptoms. Trial Registration: ClinicalTrials.gov NCT03578731; https://clinicaltrials.gov/ct2/show/NCT03578731 UR - https://www.jmir.org/2021/8/e29271 UR - http://dx.doi.org/10.2196/29271 UR - http://www.ncbi.nlm.nih.gov/pubmed/34383675 ID - info:doi/10.2196/29271 ER - TY - JOUR AU - Pratt-Chapman, Mandi AU - Moses, Jenna AU - Arem, Hannah PY - 2021/7/16 TI - Strategies for the Identification and Prevention of Survey Fraud: Data Analysis of a Web-Based Survey JO - JMIR Cancer SP - e30730 VL - 7 IS - 3 KW - cancer survivors KW - pandemic KW - COVID-19 KW - fraudulent responses KW - survey KW - research methods KW - cancer patients KW - fraud KW - CAPTCHA KW - data integrity KW - online surveys N2 - Background: To assess the impact of COVID-19 on cancer survivors, we fielded a survey promoted via email and social media in winter 2020. Examination of the data showed suspicious patterns that warranted serious review. Objective: The aim of this paper is to review the methods used to identify and prevent fraudulent survey responses. Methods: As precautions, we included a Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA), a hidden question, and instructions for respondents to type a specific word. To identify likely fraudulent data, we defined a priori indicators that warranted elimination or suspicion. If a survey contained two or more suspicious indicators, the survey was eliminated. We examined differences between the retained and eliminated data sets. Results: Of the total responses (N=1977), nearly three-fourths (n=1408) were dropped and one-fourth (n=569) were retained after data quality checking. Comparisons of the two data sets showed statistically significant differences across almost all demographic characteristics. Conclusions: Numerous precautions beyond the inclusion of a CAPTCHA are needed when fielding web-based surveys, particularly if a financial incentive is offered. UR - https://cancer.jmir.org/2021/3/e30730 UR - http://dx.doi.org/10.2196/30730 UR - http://www.ncbi.nlm.nih.gov/pubmed/34269685 ID - info:doi/10.2196/30730 ER - TY - JOUR AU - Connor, Katie AU - Hudson, Briony AU - Power, Emily PY - 2020/1/17 TI - Awareness of the Signs, Symptoms, and Risk Factors of Cancer and the Barriers to Seeking Help in the UK: Comparison of Survey Data Collected Online and Face-to-Face JO - JMIR Cancer SP - e14539 VL - 6 IS - 1 KW - neoplasms KW - surveys and questionnaires KW - cross-sectional study KW - awareness KW - help-seeking behavior KW - cancer N2 - Background: Cancer is the second leading cause of death globally, causing an estimated 9.6 million deaths in 2018. Low cancer symptom awareness has been associated with poor cancer survival for all cancers combined. The Cancer Awareness Measure (CAM) is a validated, face-to-face survey used since 2008 to measure the UK public?s awareness of the symptoms and risk factors of cancer as well as the barriers to seeking help. Objective: The aim of this study is to explore whether online data collection can produce a representative sample of the UK population, compare awareness of cancer signs and risk factors and the barriers to seeking help between data collected online and face-to-face, and examine the relationships between awareness and demographic variables. Methods: Differences in awareness of cancer signs, symptoms, and risk factors among samples were explored while adjusting for demographic differences (age, gender, ethnicity, educational level, marital status, and country of residence) to distinguish the effect of data collection method. Multivariate logistic regression models were used to calculate adjusted odds ratios for recall and recognition of signs and symptoms, risk factors, and barriers to seeking help. Results: A total of 4075 participants completed the CAM, 20% (n=819) via face-to-face interviews and 80% online (n=3256; agency A: n=1190; agency B: n=2066). Comparisons of data collected using face-to-face interviews and online surveys revealed minor differences between samples. Both methods provided representative samples of the UK population with slight differences in awareness of signs, symptoms, and risk factors and frequency of help-seeking barriers reported. Conclusions: These findings support a move to online data collection for the CAM. The flexibility afforded will enable the CAM to explore a wider range of issues related to the prevention, early diagnosis, and treatment of cancer. UR - http://cancer.jmir.org/2020/1/e14539/ UR - http://dx.doi.org/10.2196/14539 UR - http://www.ncbi.nlm.nih.gov/pubmed/31951219 ID - info:doi/10.2196/14539 ER - TY - JOUR AU - McCaffrey, Stacey AU - Black, A. Ryan AU - Nagao, Mitchell AU - Sepassi, Marjan AU - Sharma, Gaurav AU - Thornton, Susan AU - Kim, H. Youn AU - Braverman, Julia PY - 2019/01/07 TI - Measurement of Quality of Life in Patients with Mycosis Fungoides/Sézary Syndrome Cutaneous T-Cell Lymphoma: Development of an Electronic Instrument JO - J Med Internet Res SP - e11302 VL - 21 IS - 1 KW - quality of life KW - Rasch KW - patient-reported outcome KW - cutaneous T-cell lymphoma KW - mycosis fungoides KW - Sézary syndrome N2 - Background: Although the quality of life (QoL) plays an important role in treatment decision making and clinical management of mycosis fungoides (MF) or Sézary syndrome (SS) subtypes of cutaneous T-cell lymphomas (MF/SS-CTCLs), an MF- or SS-specific measure of QoL does not exist. Objective: The objective of this research was to develop and validate the first QoL instrument for MF/SS-CTCL using a patient-centered approach. Methods: A conceptual framework for the MF/SS-CTCL QoL was developed through a literature review and interviews with key opinion leaders. Concept elicitation with patients was utilized to refine the conceptual model and generate preliminary items. The items were then revised based on qualitative and quantitative feedback obtained through cognitive debriefing surveys and interviews with patients. Next, participants (N=126) completed the preliminary MF/SS-CTCL QoL and a comparator measure of health-related QoL (Skindex-29) through the PatientsLikeMe Open Research Exchange. The MF/SS-CTCL QoL was completed again 5 days later by 66 participants for the purposes of evaluating test-retest reliability. The MF/SS-CTCL QoL was finalized based on results from an empirical evaluation, which included both classical and modern test theory approaches. Specifically, this included evaluation of (1) the optimal item response theory measurement model; (2) item fit; (3) unidimensionality; (4) rating scale performance; (5) reliability; (6) test information (precision); (7) person-to-item map; (8) convergent and discriminant validity; and (9) presence of bias via differential item function. Results: Results from the comprehensive psychometric evaluation utilizing a Rasch-Grouped Rating Scale model yielded a final 12-item instrument. The rating scale functioned as expected, and the instrument exhibited adequate person reliability (.87), good to excellent test-retest reliability (r=.89, P<.001), high levels of measurement precision, and good person-to-item targeting. The correlation between the MF/SS-CTCL QoL and the Skindex-29 (r=.852, P<.001) was significantly greater than the correlation between the MF/SS-CTCL QoL and syndrome stage (r=.260, P<.001), providing support for convergent and discriminant validity. Items did not show significant bias based on gender, age, or race. Rasch scores were converted to scaled scores with qualitative descriptive categories for ease of interpretation. Conclusions: Empirical evaluation demonstrated strong evidence of excellent psychometric properties. Utilizing a patient-centered measure development approach ensures that this QoL instrument captures the information that is most meaningful and clinically relevant to patients. UR - https://www.jmir.org/2019/1/e11302/ UR - http://dx.doi.org/10.2196/11302 UR - http://www.ncbi.nlm.nih.gov/pubmed/30617041 ID - info:doi/10.2196/11302 ER - TY - JOUR AU - Dewitt, James AU - Capistrant, Benjamin AU - Kohli, Nidhi AU - Rosser, Simon B. R. AU - Mitteldorf, Darryl AU - Merengwa, Enyinnaya AU - West, William PY - 2018/04/24 TI - Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation JO - JMIR Res Protoc SP - e96 VL - 7 IS - 4 KW - fraudulent data KW - data accuracy KW - research and design KW - research activities KW - data analysis N2 - Background: While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. Objective: This paper reports the challenges of survey validation inherent in a small Web-based health survey research. Methods: The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Results: Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Conclusions: Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed. UR - http://www.researchprotocols.org/2018/4/e96/ UR - http://dx.doi.org/10.2196/resprot.7655 UR - http://www.ncbi.nlm.nih.gov/pubmed/29691203 ID - info:doi/10.2196/resprot.7655 ER - TY - JOUR AU - Girgis, Afaf AU - Durcinoska, Ivana AU - Levesque, V. Janelle AU - Gerges, Martha AU - Sandell, Tiffany AU - Arnold, Anthony AU - Delaney, P. Geoff AU - PY - 2017/10/02 TI - eHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability JO - J Med Internet Res SP - e330 VL - 19 IS - 10 KW - patient reported outcome measures KW - eHealth KW - self-management KW - medical oncology KW - patient-centered care KW - electronic health records N2 - Background: Despite accumulating evidence indicating that collecting patient-reported outcomes (PROs) and transferring results to the treating health professional in real time has the potential to improve patient well-being and cancer outcomes, this practice is not widespread. Objective: The aim of this study was to test the feasibility and acceptability of PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care), a newly developed electronic health (eHealth) system that facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. Methods: We developed an eHealth system in consultation with content-specific expert advisory groups and tested it with patients receiving treatment or follow-up care in two hospitals in New South Wales, Australia, over a 3-month period. Participants were recruited in clinic and completed self-report Web-based assessments either just before their upcoming clinical consultation or every 4 weeks if in follow-up care. A mixed methods approach was used to evaluate feasibility and acceptability of PROMPT-Care; data collected throughout the study informed the accuracy and completeness of data transfer procedures, and extent of missing data was determined from participants? assessments. Patients participated in cognitive interviews while completing their first assessment and completed evaluation surveys and interviews at study-end to assess system acceptability and usefulness of patient self-management resources, and oncology staff were interviewed at study-end to determine the acceptability and perceived usefulness of real-time PRO reporting. Results: A total of 42 patients consented to the study; 7 patients were withdrawn before starting the intervention primarily because of changes in eligibility. Overall, 35 patients (13 on treatment and 22 in follow-up) completed 67 assessments during the study period. Mean completeness of patient-reported data was 93%, with 100% accuracy of data transfer. Ten patients completed cognitive interviews, 28 completed evaluation surveys, and 14 completed evaluation interviews at study-end. PROMPT-Care patient acceptability was high?100% (28/28) reported the time to complete the Web-based assessments (average 15 min) as about right, most willing to answer more questions (79%, 22/28 yes), 96% (27/28) found the Web-based assessment easier or same as completing a paper copy, and they valued the self-management resources . Oncology staff (n=5) also reported high acceptability and potential feasibility of the system. Conclusions: Patients and oncology staff found the PROMPT-Care system to be highly acceptable, and the results suggest that it would be feasible to implement it into an oncology setting. Suggested modifications to the patient assessment survey, clinician access to the reports, and system requirements will be made as part of the next stage of large-scale testing and future implementation of the system as part of routine care. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0). UR - https://www.jmir.org/2017/10/e330/ UR - http://dx.doi.org/10.2196/jmir.8360 UR - http://www.ncbi.nlm.nih.gov/pubmed/28970188 ID - info:doi/10.2196/jmir.8360 ER - TY - JOUR AU - Norquist, Josephine AU - Chirovsky, Diana AU - Munshi, Teja AU - Tolley, Chloe AU - Panter, Charlotte AU - Gater, Adam PY - 2017/05/12 TI - Assessing the Comparability of Paper and Electronic Versions of the EORTC QOL Module for Head and Neck Cancer: A Qualitative Study JO - JMIR Cancer SP - e7 VL - 3 IS - 1 KW - ePRO KW - comparability KW - EORTC QLQ-C30 KW - head and neck cancer KW - quality of life questionnaire N2 - Background: Patient-reported outcome (PRO) instruments are important tools for monitoring disease activity and response to treatment in clinical trials and clinical practice. In recent years, there have been movements away from traditional pen-and-paper PROs towards electronic administration. When using electronic PROs (ePROs), evidence that respondents complete ePROs in a similar way to their paper counterparts provides assurance that the two modes of administration are comparable or equivalent. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 item (EORTC QLQ-C30) and associated disease-specific modules are among the most widely used PROs in oncology. Although studies have evaluated the comparability and equivalence of electronic and original paper versions of the EORTC QLQ-C30, no such studies have been conducted to date for the head and neck cancer specific module (EORTC QLQ-H&N35). Objective: This study aimed to qualitatively assess the comparability of paper and electronic versions of the EORTC QLQ-H&N35. Methods: Ten head and neck cancer patients in the United States underwent structured cognitive debriefing and usability interviews. An open randomized crossover design was used in which participants completed the two modes of administration allocated in a randomized order. Using a ?think-aloud? process, participants were asked to speak their thoughts aloud while completing the EORTC QLQ-H&N35. They were thoroughly debriefed on their responses to determine consistency in interpretation and cognitive process when completing the instrument in both paper and electronic format. Results: Participants reported that the EORTC QLQ-H&N35 demonstrated excellent qualitative comparability between modes of administration. The proportion of noncomparable responses (ie, where the thought process used by participants for selecting responses appeared to be different) observed in the study was low (11/350 response pairs [35 items x 10 participants]; 3.1%). Evidence of noncomparability was observed for 9 of the 35 items of the EORTC QLQ-H&N35 and in no more than 2 participants per item. In addition, there were no apparent differences in level of comparability between individual participants or between modes of administration. Conclusions: Mode of administration does not affect participants? response to, or interpretation of, items in the EORTC QLQ-H&N35. The findings from this study add to the existing evidence supporting the use of electronic versions of the EORTC instruments when migrated to electronic platforms according to best practice guidelines. UR - http://cancer.jmir.org/2017/1/e7/ UR - http://dx.doi.org/10.2196/cancer.7202 UR - http://www.ncbi.nlm.nih.gov/pubmed/28500019 ID - info:doi/10.2196/cancer.7202 ER - TY - JOUR AU - Kilsdonk, Ellen AU - van Dulmen-den Broeder, Eline AU - van der Pal, J. Helena AU - Hollema, Nynke AU - Kremer, C. Leontien AU - van den Heuvel-Eibrink, M. Marry AU - van Leeuwen, E. Flora AU - Jaspers, W. Monique AU - van den Berg, H. Marleen PY - 2015/11/24 TI - Effect of Web-Based Versus Paper-Based Questionnaires and Follow-Up Strategies on Participation Rates of Dutch Childhood Cancer Survivors: A Randomized Controlled Trial JO - JMIR Cancer SP - e11 VL - 1 IS - 2 KW - childhood cancer survivors KW - follow-up strategies KW - participation rates KW - questionnaires KW - questionnaire mode N2 - Background: Questionnaires are widely used in survey research, especially in cohort studies. However, participation in questionnaire studies has been declining over the past decades. Because high participation rates are needed to limit the risk of selection bias and produce valid results, it is important to investigate invitation strategies which may improve participation. Objectives: The purpose of this study is to investigate the effect of Web-based versus paper-based questionnaires on participation rates in a questionnaire survey on late effects among childhood cancer survivors (CCSs). Methods: A total of 750 CCSs were randomized across 3 study arms. The initial invitation in study arms 1 and 2 consisted of a Web-based questionnaire only, whereas in study arm 3 this invitation was complemented with a paper-based version of the questionnaire. The first postal reminder, sent to the nonresponding CCSs in all 3 study arms, consisted of either a reminder letter only (study arms 1 and 3) or a reminder letter complemented with a paper-based questionnaire (study arm 2). The second postal reminder was restricted to CCSs in study arms 1 and 2, with only those in study arm 1 also receiving a paper-based questionnaire. CCSs in study arm 3 received a second reminder by telephone instead of by mail. In contrast to CCSs in study arm 3, CCSs in study arms 1 and 2 received a third reminder, this time by telephone. Results: Overall, 58.1% (436/750) of the CCSs participated in the survey. Participation rates were equal in all 3 study arms with 57.4% (143/249) in arm 1, 60.6% (152/251) in arm 2, and 56.4% (141/250) in arm 3 (P=.09). Participation rates of CCSs who received an initial invitation for the Web-based questionnaire only and CCSs who received an invitation to complete either a paper-based or Web-based questionnaire did not differ (P=.55). After the first postal reminder, participation rates of CCSs invited for the Web-based questionnaire only also did not differ compared with CCSs invited for both the Web-based and paper-based questionnaires (P=.48). In general, CCSs preferred the paper-based over the Web-based questionnaire, and those completing the paper-based questionnaire were more often unemployed (P=.004) and lower educated (P<.001). Conclusion: Invitation strategies offering a Web-based questionnaire without a paper-based alternative at first invitation can be used without compromising participation rates of CCS. Offering the choice between paper- and Web-based questionnaires seems to result in the highest accrual participation rate. Future research should look into the quality of the data delivered by both questionnaires filled in by respondents themselves. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 84711754; http://www.controlled-trials.com/ISRCTN84711754 (Archived by WebCite at http://www.webcitation.org/6c9ZB8paX) UR - http://cancer.jmir.org/2015/2/e11/ UR - http://dx.doi.org/10.2196/cancer.3905 UR - http://www.ncbi.nlm.nih.gov/pubmed/28410161 ID - info:doi/10.2196/cancer.3905 ER -