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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 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 digital measures of depression, anxiety, mental wellbeing and confidence in managing their own health Online questionnaires will be administered preprogramme and six weeks postprogramme RESULTS: All people who had requested access to the Hope Programme from Macmillan Cancer Support (N=61) will be invited to participate in the trial Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020 Postprogramme data collection was completed by the end of August 2020 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 INTERNATIONAL REGISTERED REPORT: DERR1-10 2196/24264
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