@Article{info:doi/10.2196/28322,
author="Wright, Hayley
and Martin, Faith
and Clyne, Wendy
and Clark, Cain C T
and Matouskova, Gabriela
and McGillion, Michael
and Turner, Andrew",
title="A Digital Self-management Program (Help to Overcome Problems Effectively) for People Living With Cancer: Feasibility Randomized Controlled Trial",
journal="J Med Internet Res",
year="2021",
month="Nov",
day="5",
volume="23",
number="11",
pages="e28322",
keywords="self-management; cancer; survivorship; digital; positive psychology",
abstract="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 ",
issn="1438-8871",
doi="10.2196/28322",
url="https://www.jmir.org/2021/11/e28322",
url="https://doi.org/10.2196/28322",
url="http://www.ncbi.nlm.nih.gov/pubmed/34738912"
}