Michelle J M Smits, Catherine A W Bolman, Ilse Mesters, Lilian Lechner
{"title":"Blended Care Intervention for Cancer Aftercare in General Practice Centers: Protocol for a Randomized Controlled Trial.","authors":"Michelle J M Smits, Catherine A W Bolman, Ilse Mesters, Lilian Lechner","doi":"10.2196/64662","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Combining effective eHealth programs with face-to-face consultations in general practice may help general practitioners care for survivors of cancer.</p><p><strong>Objective: </strong>This study protocol describes a 2-armed randomized controlled trial to evaluate the cost-effectiveness of a blended intervention integrating the Cancer Aftercare Guide in general practice centers (GPCs).</p><p><strong>Methods: </strong>A parallel-group design will compare an intervention group with a waiting list control group. Participants will be nested within GPCs and randomization will occur at the GPC level. The participants in the intervention group will receive a blended care intervention. In contrast, the participants in the waiting list control group will receive care as usual for the duration of this study and will receive the online intervention afterward. All participants will be asked to complete an online questionnaire at baseline, 6 months, and 12 months after baseline, measuring self-reported adherence to lifestyle recommendations, psychosocial well-being, and quality of life. A process evaluation and cost evaluation are also included in this study. The effects will be evaluated based on differences in residual change scores between intervention and control group participants, using multilevel linear regression analyses. Moreover, effect analyses will be supplemented with Bayes factor analyses. Finally, an economic evaluation will be conducted from a societal perspective and will include medical costs, productivity costs, and costs of the blended care intervention.</p><p><strong>Results: </strong>This study was funded in July 2020. Data collection started in August 2022 and is likely to be completed by April 2025. As of December 2024, a total of 127 participants have been included in this study, recruited across 26 GPCs in the Netherlands. Data analysis will commence once data collection is completed. Data analysis is estimated to start in the spring of 2025. The results will likely be published in 2026.</p><p><strong>Conclusions: </strong>The results will provide insight into the effectiveness of blended care and may be relevant to cancer aftercare, general practice, and the field of eHealth implementation in general. Potential challenges lie in recruitment due to the strain on the health care system since the COVID-19 pandemic.</p><p><strong>Trial registration: </strong>ISRCTN ISRCTN12451453; https://www.isrctn.com/ISRCTN12451453.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/64662.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64662"},"PeriodicalIF":1.4000,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JMIR Research Protocols","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2196/64662","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Combining effective eHealth programs with face-to-face consultations in general practice may help general practitioners care for survivors of cancer.
Objective: This study protocol describes a 2-armed randomized controlled trial to evaluate the cost-effectiveness of a blended intervention integrating the Cancer Aftercare Guide in general practice centers (GPCs).
Methods: A parallel-group design will compare an intervention group with a waiting list control group. Participants will be nested within GPCs and randomization will occur at the GPC level. The participants in the intervention group will receive a blended care intervention. In contrast, the participants in the waiting list control group will receive care as usual for the duration of this study and will receive the online intervention afterward. All participants will be asked to complete an online questionnaire at baseline, 6 months, and 12 months after baseline, measuring self-reported adherence to lifestyle recommendations, psychosocial well-being, and quality of life. A process evaluation and cost evaluation are also included in this study. The effects will be evaluated based on differences in residual change scores between intervention and control group participants, using multilevel linear regression analyses. Moreover, effect analyses will be supplemented with Bayes factor analyses. Finally, an economic evaluation will be conducted from a societal perspective and will include medical costs, productivity costs, and costs of the blended care intervention.
Results: This study was funded in July 2020. Data collection started in August 2022 and is likely to be completed by April 2025. As of December 2024, a total of 127 participants have been included in this study, recruited across 26 GPCs in the Netherlands. Data analysis will commence once data collection is completed. Data analysis is estimated to start in the spring of 2025. The results will likely be published in 2026.
Conclusions: The results will provide insight into the effectiveness of blended care and may be relevant to cancer aftercare, general practice, and the field of eHealth implementation in general. Potential challenges lie in recruitment due to the strain on the health care system since the COVID-19 pandemic.