Clinical trial · Interventional
Feasibility Study of ABC for Women Treated for Breast Cancer
A Feasibility Study to Inform an RCT to Evaluate 'Accepting Your Body After Cancer', an Online-delivered, Group-based CBT Body Image Intervention, for Women Who Have Received Treatment for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators aim to assess the feasibility and acceptability of conducting a randomised controlled trial (RCT) to test whether receiving ABC (an online-delivered, Cognitive Behavioural Therapy \[CBT\], group-based, body image programme) alongside a psychoeducational body image booklet provides greater benefits to women treated for breast cancer compared to a receiving a psychoeducational body image booklet alone. Results from this feasibility study will inform the design, management, and future delivery of a definitive randomised controlled trial to assess effectiveness and cost-effectiveness of ABC. Specific objectives are to: * Establish appropriate, inclusive, and acceptable methods of participant recruitment, retention, and management procedures. * Establish the feasibility and acceptability of quantitative data collection, including determining appropriate primary and secondary outcome measures. * Adapt and test a measure of health and social care service use, to inform a future economic evaluation. * Establish intervention adherence and acceptability (of online setting) among participants and ABC facilitators. Participants will be randomised to either the intervention or control arm. The control arm will receive the Macmillan Cancer Support psychoeducational body image booklet. The intervention arm will receive the Macmillan booklet and the ABC programme, a 7-session, CBT group-based programme delivered online. All participants will complete self-report validated outcome measures at weeks 1 (T1; baseline/pre-intervention), 9 (T2; immediate post-intervention), 20 (T3; three-month post intervention), and 32 (T4; six-month post intervention). Following drop-out or completion of all study procedures, a subset of participants will be invited to take part in interviews.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accepting your Body after Cancer | Behavioral | — | UNRESOLVED |
| Macmillan body image booklet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ABC + Macmillan body image booklet
- description
- Accepting your Body after Cancer (ABC) + Macmillan Cancer Support psycho-educational body image booklet ABC comprises seven 2-hour group sessions (with approximately 8 women per group) delivered online via Microsoft Teams and across 7 consecutive weeks. The intervention aims to improve body image among women treated for BC. Rooted in CBT, ABC uses strategies to alter unhelpful thoughts, reduce anxiety, and promote non-avoidant behaviours. Other topics are also explored, including sociocultural pressures for women, intimacy, physical activity, self-care, mindfulness, and relaxation. The sessions will be guided using PowerPoint slides, which will include text, images, and videos. Each session will include individual and group-based activities, and participants will be asked to complete between-session readings and activities. (Macmillan Cancer Support psycho-educational body image booklet is described below).
- interventionNames
- Behavioral: Accepting your Body after Cancer
- Behavioral: Macmillan body image booklet
- type
- OTHER
- label
- Macmillan body image booklet (usual care)
- description
- Macmillan Cancer Support psycho-educational body image booklet (only) Discussions with PPI advisors indicated that some form of body image-specific support should be provided for the control arm. Macmillan's freely available psychoeducational body image booklet was considered appropriate, given that the thorough 77-page booklet provides a substantial amount of support and guidance relating to managing body image concerns. It explains the effects of cancer on body image, and provides practical guidance (e.g., make-up) and psychoeducational guidance (e.g., managing others' reactions), in addition to some CBT strategies. Upon randomisation to the control arm, participants will be sent the Macmillan body image booklet and encouraged to work through it gradually. The booklet can be accessed via the following webpage: https://cdn.macmillan.org.uk/dfsmedia/1a6f23537f7f4519bb0cf14c45b2a629/791-source/body-image-mac14192
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Identify as a woman. * 18+ years old. * Finished active treatment for breast cancer (including chemotherapy, radiotherapy, targeted and immunotherapy) for breast cancer. There is no time limit on when they finished this treatment. Women on endocrine therapy are eligible to take part. Women with metastatic disease are eligible to take part if on endocrine therapy only. * Completed primary oncological breast cancer surgery with breast conserving surgery or mastectomy with or without immediate definitive breast reconstruction. Women awaiting delayed breast reconstruction, revision or contralateral symmetrisation surgery are eligible to take part provided this surgery is not planned within the duration of the study. * Recognises that they are experiencing BID as a result of treatment (regarding how the body looks and/or feels). * Has the capacity to provide informed consent or supported informed consent (e.g., with a family member/friend). * Has sufficient understanding of English (as the intervention content and measures are currently only available in English). Exclusion Criteria: * Still undergoing active treatment for breast cancer (e.g., oncological breast surgery including those awaiting the second stage of planned expander/implant reconstruction, chemotherapy, targeted therapies, radiotherapy). * Undergoing exploration for cancer recurrence. * Has not received a diagnosis of breast cancer e.g., has had prophylactic treatment for a gene mutation (such as risk-reducing mastectomy). * Has an eating disorder. * Unable to provide informed consent.
References
Publications (36)
- BACKGROUNDBegovic-Juhant A, Chmielewski A, Iwuagwu S, Chapman LA. Impact of body image on depression and quality of life among women with breast cancer. J Psychosoc Oncol. 2012;30(4):446-60. doi: 10.1080/07347332.2012.684856. PMID 22747107
- BACKGROUNDBrady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974. PMID 9060536
- BACKGROUNDBraun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa
- BACKGROUNDBraun, V. and Clarke, V. (2022) Conceptual and design thinking for thematic analysis. Qualitative Psychology. 9(1): p. 3.
- BACKGROUNDCarreira H, Williams R, Funston G, Stanway S, Bhaskaran K. Associations between breast cancer survivorship and adverse mental health outcomes: A matched population-based cohort study in the United Kingdom. PLoS Med. 2021 Jan 7;18(1):e1003504. doi: 10.1371/journal.pmed.1003504. eCollection 2021 Jan. PMID 33411711
- BACKGROUNDCash, T.F. and Pruzinsky, T. (2002). Body image: a handbook of theory, research, and clinical practice. New York: Guilford Publications.
- BACKGROUNDCohen M, Anderson RC, Jensik K, Xiang Q, Pruszynski J, Walker AP. Communication between breast cancer patients and their physicians about breast-related body image issues. Plast Surg Nurs. 2012 Jul-Aug;32(3):101-5. doi: 10.1097/PSN.0b013e3182650994. PMID 22929196
- BACKGROUNDCousson-Gelie F, Bruchon-Schweitzer M, Dilhuydy JM, Jutand MA. Do anxiety, body image, social support and coping strategies predict survival in breast cancer? A ten-year follow-up study. Psychosomatics. 2007 May-Jun;48(3):211-6. doi: 10.1176/appi.psy.48.3.211.