JMIR Publications

ABSTRACT

Background:

Trial Design We present the results from a feasibility, randomised wait-list control group parallel design study, with a 1:1 allocation ratio. Participants were randomised to an intervention group or a waitlist control group.The intervention was a six-week digital self-management program (HOPE Program) for people with cancer.

Objective:

The aim of this study was to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive RCT. Additionally, 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 take part 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 wellbeing, depression, anxiety and patient activation (i.e. confidence to manage their cancer). The intervention and data collection took place online.

Results:

The recruitment rate was 77% (N=47). Forty one participants (n=41) completed the baseline questionnaires and were randomised to either the intervention group (n=21) or waitlist control group (n=20). The retention rate (attending all program sessions) was over 50% (all n=21, 51.2%; intervention group n=10, 47.6%; control group n=11, 55.0%), the follow up rate (completing all questionnaires) was over 80% (all 80.5%, n=33; intervention group 76.2%, n=16; control group 85.0%, n=17), and completion rate (attending 3 sessions and completing all questionnaires) was over 60% (all n=25, 61.0%; intervention group n=13, 61.9%; control group n=12, 60.0%). Engagement data showed that participants viewed between half (n=5.1, 51.0%) and three quarters (n=12.2, 76.3%) of the pages in each session.

Conclusions:

All progression criteria for a definitive trial were met, as supported by the primary outcome data. On average, participants showed improved postprogram scores on measures of positive mental wellbeing, 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 control group. Clinical Trial: This feasibility randomised wait-list control trial was retrospectively registered with the ISRCTN registry (https://www.isrctn.com/ISRCTN79623250) on Nov 4, 2020. The feasibility trial protocol has been registered and published [International Registered Report Identifier (IRRID): DERR1-10.2196/24264.