A randomised controlled trial comparing internet-delivered cognitive behavioural therapy (iCBT) with and without main carer access versus treatment-as-usual for depression and anxiety among breast cancer survivors: Study protocol

BACKGROUND: Depression and anxiety are common problems among breast cancer survivors. Carer support is one of the most important determinants of women's psychological wellbeing. Survivors' distress can be alleviated by giving carers access to survivors' evidence-based treatment, which will help carers understand what survivors have been going through and help survivors feel more supported. Given the limited access to evidence-based treatments, an adapted internet-delivered cognitive behavioural therapy (iCBT) intervention for breast cancer survivors, but also open for carers' access, has the potential to decrease survivors' depression and anxiety symptoms and improve cancer-related communication and relationship quality between survivors and carers. OBJECTIVES: This study evaluates (1) the effectiveness of a guided iCBT intervention for depression and/or anxiety symptoms among breast cancer survivors with and without main carer access, and (2) the acceptability and satisfaction with the iCBT programme. METHOD: In this pilot study comparing the effectiveness of an adapted 7-week iCBT without main carer access against the iCBT with main carer access and treatment-as-usual control, 108 breast cancer survivors will be recruited and then randomised to either (1) treatment (n = 72) or (2) treatment-as-usual control group (n = 36) with a 2:1 ratio. The participants in the treatment group will be assigned to either iCBT alone or iCBT with the main carer also having access to the same content based on their preference. The primary outcome measure is the Hospital Anxiety and Depression Scale, and alongside secondary measures such as Cancer-Related Quality of Life, Breast Cancer Worry Scale, Brief COPE, and Medical Outcomes Study Social Support Survey will be completed by the survivors at baseline, post-treatment, and 2-month follow-up. Survivors who have carers will also complete Survivor-Carer Cancer Communication and Relationship Quality measures to provide insights into the effects of carer access. To assess the acceptability and satisfaction with the programme, survivors and their main carers will fill out the Helpful Aspects of Therapy Form (HAT) and Satisfaction with Online Treatment (SAT). Programme effectiveness and the effects of carer access on primary and secondary outcome measures will be evaluated on intention-to-treat and per-protocol basis using Linear-Mixed-Models. DISCUSSION: This is the first trial comparing the effectiveness and acceptability of iCBT with and without carer access for depression and anxiety among breast cancer survivors. The findings of this study will provide novel data on the acceptability of iCBT programmes for breast cancer survivors and the impact of carer access on them and their carers.