A Digital Self-management Program (Help to Overcome Problems Effectively) for People Living With Cancer: Feasibility Randomized Controlled Trial.

ABSTRACT

BACKGROUND: We present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 11 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.