Background: The majority of cancer survivors will experience some adverse effects as a result of their cancer and its treatment. Lack of information and support can make managing these problems challenging for survivors, particularly among those with low self-efficacy. Here we describe the development and exploratory trial protocol of the RESTORE online intervention to enhance self-efficacy to self manage cancer related fatigue.
Methods/Design: Informed by the MRC guidance on developing and evaluating complex interventions, this intervention was developed in partnership with survivors, Macmillan partners, clinicians and academic experts. A prototype was created and underwent user testing. A two-armed randomised controlled trial will compare the RESTORE intervention with a ‘Coping with Fatigue’ leaflet. The intervention consists of five weekly sessions with components and activities informed by self-efficacy theory. The study population consists of cancer survivors within five years of completion of treatment with curative intent (target sample size N=125). An initial pilot phase will determine feasibility and acceptability of proposed methods. The primary aim is to test the value of the intervention (‘proof of concept’) to increase self-efficacy to manage fatigue related problems. Secondary aims include impact on the perception and experience of fatigue and quality of life. Outcome measures will be collected at baseline, 6 weeks (completion of intervention) and 3 months. Process evaluation (including telephone interviews) will also be conducted.
Discussion: Data from this trial will be used to refine the intervention and conduct a full-scale RCT. We hope to roll out the intervention in clinical practice and expand it to address other cancer related problems important to survivors following primary cancer treatment.