Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 11, 2020
Date Accepted: Oct 20, 2020
Date Submitted to PubMed: Nov 25, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The digital Help to Overcome Problems Effectively (Hope) Programme for people living with cancer during the COVID-19 pandemic: Protocol for a feasibility randomised controlled trial
ABSTRACT
Background:
During the COVID-19 lockdown period in the UK that began on 23 March 2020, more than a quarter of a million people with cancer (PWC) reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management programme for PWC, designed to provide support for distress, unmet needs and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope programme has become ever more vital for PWC. Previous pre-post studies of the digital Hope programme have found reduced anxiety and depression and improved wellbeing for PWC. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies.
Objective:
We now present a protocol for a feasibility randomised controlled trial of the digital Hope programme for PWC during the COVID-19 pandemic. Primary outcomes will be recruitment, drop-out and adherence rates, estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and wellbeing, and acceptability of the intervention.
Methods:
Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility waitlist randomised controlled trial (RCT) design, with PWC being randomised to join the digital Hope Programme immediately (IG) or join a six-week waiting list (WLCG) with a 1:1 allocation ratio. PWC will complete measures of psychological wellbeing and confidence in managing their own health. Online questionnaires will be administered preprogramme and six weeks postprogramme.
Results:
At manuscript submission, all people who had requested access to the Hope Programme from Macmillan Cancer Support (n=61) have been invited to participate in the trial. Whilst 47 PWC consented to join the study (n=47, 77%), only those participants who completed the baseline measures and randomisation were included in the study (n=42). Participants were randomised to join the digital Hope intervention (IG, n=21) or a waiting list (WLCG, n=21).
Conclusions:
This feasibility study will provide data to inform the design of a future definitive trial. Wider scale provision of the digital Hope Programme has potential to improve the lives of thousands of PWC and reduce the burden on healthcare providers during these unprecedented times.
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