@文章{信息:doi/10.2196/28322,作者=“Wright, Hayley和Martin, Faith和Clyne, Wendy和Clark, Cain C T和Matouskova, Gabriela和McGillion, Michael和Turner, Andrew”,标题=“癌症患者的数字自我管理计划(帮助有效克服问题):可行性随机控制试验”,期刊=“J Med Internet Res”,年=“2021”,月=“11”,日=“5”,卷=“23”,数字=“11”,页=“e28322”,关键词=“自我管理;癌症;生存;数字;背景:我们提出了一个1:1分配比例的可行性随机候补对照组(CG)并行设计研究的结果。参与者被随机分为干预组(IG)或候补组(CG)。这项干预是一项为期6周的数字自我管理计划,名为“帮助有效克服问题”(HOPE),针对癌症患者。目的:本研究旨在测试癌症患者数字化自我管理计划的可行性。这将为最终随机对照试验的设计提供依据。此外,通过次要结果对HOPE项目影响的初步评估将用于评估试验背景下的疗效信号。 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 ", issn="1438-8871", doi="10.2196/28322", url="//www.mybigtv.com/2021/11/e28322", url="https://doi.org/10.2196/28322", url="http://www.ncbi.nlm.nih.gov/pubmed/34738912" }
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