Feasibility of an RCT for a body image programme for breast cancer
Research type
Research Study
Full title
A feasibility study to inform a Randomised Controlled Trial to evaluate an online-delivered group-based cognitive behavioural therapy (CBT) body image intervention for women who have received treatment for breast cancer
IRAS ID
327507
Contact name
Helena Lewis-Smith
Contact email
Sponsor organisation
University of the West of England
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
Nearly half of all women living beyond breast cancer are distressed by treatment-related changes to their body (e.g., scarring). Without appropriate support, they can become anxious and depressed, face intimacy issues, and die earlier. At present, there is a lack of support for women. However, early testing of a cognitive-behavioural-therapy, group-based programme, ‘Accepting your Body after Cancer’ (ABC), has demonstrated benefits.
Online delivery of this programme could benefit greater numbers of women across the UK. However, before resources are invested in testing this on a large scale, this NIHR-funded study aims to determine whether, and how, this could be done. Research questions include: “Will enough women want to take part in the research?”; “What will women think of the online-delivered programme?”; “Are the proposed measures appropriate for women?”; “Will women complete the measures at all timepoints?”
Five NHS sites across England will recruit 120 women who have finished active treatment for breast cancer. They will be randomly assigned to one of two groups. Group 1 will receive a Macmillan information booklet on managing distressing body changes. Group 2 will receive the same information booklet and the proposed programme (consisting of seven weekly online sessions delivered by Maggie’s cancer charity).
Participants will complete a self-report questionnaire at four timepoints: pre-intervention (Week 1), immediate post-intervention (Week 9), three-month post-intervention (Week 20), and six-month post-intervention (Week 32). A subsample of participants will be interviewed at different points. We will record the number of women who take part in the research, explore their experience of the process and programme, and their thoughts on the measures.
Findings will inform how to design a large-scale study to examine the effects of the programme, for which a funding application will be submitted. If effective, the programme could benefit thousands of women treated for breast cancer across the UK.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
24/NE/0092
Date of REC Opinion
22 May 2024
REC opinion
Favourable Opinion