Abstract
BackgroundWe 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.ObjectiveThis 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.MethodsParticipants 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.ResultsThe 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.ConclusionsAll 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 RegistrationISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250International Registered Report Identifier (IRRID)RR2-10.2196/24264
Highlights
Background and RationaleAs of May 2021, the United Kingdom has seen 3 periods of national lockdown and widespread social and physical distancing measures implemented by the government in an attempt to curtail the spread of SARS-CoV-2
The follow-up rate was greater than 80%
The advent of the digital Help to Overcome Problems Effectively (HOPE) program has coincided with requests from academics, leading cancer charities, and the National Health Service (NHS), for more person-centered cancer self-management, especially during the recent global pandemic [2,3,8]
Summary
As of May 2021, the United Kingdom has seen 3 periods of national lockdown and widespread social and physical distancing measures implemented by the government in an attempt to curtail the spread of SARS-CoV-2. Such measures have resulted in significant reductions in the delivery of cancer services in the United Kingdom, as pressures on health services, lockdown demands, and the need to reduce face-to-face interactions have taken precedence [1]. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer
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