Feasibility Study of ABC for Women Treated for Breast Cancer - Trial NCT06412341
Access comprehensive clinical trial information for NCT06412341 through Pure Global AI's free database. This phase not specified trial is sponsored by University of the West of England and is currently Not yet recruiting. The study focuses on Breast Cancer Female. Target enrollment is 120 participants.
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Study Focus
Sponsor & Location
University of the West of England
Timeline & Enrollment
N/A
May 05, 2024
Mar 31, 2026
Primary Outcome
Recruitment rates,Response rates - Self-report outcome measures,Response rates - Intervention arm,Response rates - Control arm,Quantitative assessment of acceptability - ABC,Quantitative assessment of acceptability - Research process,Qualitative assessment of acceptability - ABC (Open-ended questions),Qualitative assessment of acceptability - ABC (interviews,Qualitative assessment of acceptability - Research process (Open-ended questions),Qualitative assessment of acceptability - Research process (interviews),Qualitative assessment of acceptability - ABC course facilitators
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06412341
Non-Device Trial