Feasibility Study of ABC for Women Treated for Breast Cancer

NCT06412341 | Completed

• 1 other identifier: 10473704
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer Female

Keywords

Body Image; Feasibility; Intervention; Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (11)

• Recruitment rates

  The number of women who are recruited into the study, with attention to the method by which women were recruited and their demographic diversity.

  Baseline (T1; Week 1)

• Response rates - Self-report outcome measures

  The proportion of women who complete the self-report measures at each time point.

  Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)

• Response rates - Intervention arm

  the proportion of women completing ABC (the number of sessions attended and the number of between-session activities completed)

  Baseline to immediate post-intervention (T1; Week 1 - T2; Week 9)

• Response rates - Control arm

  The proportion of participants in the control arm reading the Macmillan body image booklet (plus the percentage of booklet read)

  Baseline (T1; Week 1) to 6-month post-intervention (T4; Week 32)

• Quantitative assessment of acceptability - ABC

  Rating scale relating to the acceptability of the ABC course (e.g., the group format, online nature, between-session activities). Completed by those in intervention arm only.

  Immediate post-intervention (T2; Week 9)

• Quantitative assessment of acceptability - Research process

  Rating scale to explore acceptability of the research process generally (e.g., information provided about the study, randomisation process, questionnaires) - to be completed by all participants

  6-month post-intervention (T4; Week 32)

• Qualitative assessment of acceptability - ABC (Open-ended questions)

  Open-ended questions asking about the acceptability of the ABC course (e.g., the group format, online nature, between-session activities) - to be completed at immediate post-intervention (T2) by participants in the intervention group only.

  Immediate post-intervention (T2; Week 9)

• Qualitative assessment of acceptability - ABC (interviews

  Interviews of participant in the intervention group will include questions asking about the acceptability of the ABC course. Interviews will occur across the study period.

  Immediate post-intervention (T2; Week 9) to 6-month post-intervention (T4; Week 32)

• Qualitative assessment of acceptability - Research process (Open-ended questions)

  Open-ended questions to explore acceptability of the research process generally (e.g., information provided about the study, randomisation process, questionnaires) - to be completed by all participants in the six-month post-intervention assessment

  6-month post-intervention (T4; Week 32)

• Qualitative assessment of acceptability - Research process (interviews)

  All interviews will include questions asking about the acceptability of the research process. Interviews will occur across the study period.

  Baseline (T1; Week 1) to 6-month post-intervention (T4; Week 32)

• Qualitative assessment of acceptability - ABC course facilitators

  All ABC facilitators will also be interviewed following intervention delivery to explore their experience of the programme, as well as their perceived barriers to participant retention, and solutions.

  Immediate post-intervention (T2; Week 9) to 6-month post-intervention (T4; Week 32)

Secondary Outcomes (9)

• Kessler Psychological Distress Scale (Kessler et al., 2002)

  Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)

• Body Appreciation Scale-2 (Tylka & Wood-Barcalow, 2015)

  Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)

• Functional Assessment of Cancer Therapy - Breast (FACT-B Version 4): Breast Cancer Subscale (Brady et al., 1997)

  Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)

• Hopwood Body Image Scale (Hopwood et al., 2001)

  Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)

• BREAST-Q: Sexual Well-Being Scale (Pusic et al., 2009)

  Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)

Study Arms (2)

ABC + Macmillan body image booklet

EXPERIMENTAL

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).

Behavioral: Accepting your Body after Cancer; Behavioral: Macmillan body image booklet

Macmillan body image booklet (usual care)

OTHER

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

Behavioral: Macmillan body image booklet

Interventions

Accepting your Body after Cancer BEHAVIORAL

See 'Arm Description'

ABC + Macmillan body image booklet

Macmillan body image booklet BEHAVIORAL

See 'Arm Description'

ABC + Macmillan body image booklet; Macmillan body image booklet (usual care)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self identify as a woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as a woman.
• + 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the West of England: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Centre for Appearance Research, University of the West of England

Bristol, Bristol, BS16 1QY, United Kingdom

Location

Related Publications (36)

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  PMID: 39843373 DERIVED

Study Officials

• Helena Lewis-Smith

  University of the West of England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 14, 2024
• Study Start: July 23, 2024
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

GB (1)