Feasibility study for an group online body image intervention for women who have received treatment for breast cancer
| ISRCTN | ISRCTN88199566 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88199566 |
| IRAS number | 327507 |
| Secondary identifying numbers | IRAS 327507, CPMS 55828 |
- Submission date
- 21/06/2024
- Registration date
- 27/06/2024
- Last edited
- 29/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Breast cancer is the most common cancer in women in the UK. Many women feel unhappy with how their body looks and feels following treatment for breast cancer. ‘Accepting your Body after Cancer’ (ABC) is a group-based programme that has been tested in a small study and found to help women. More women could use ABC if it was delivered online, and we want to do a large study to see if ABC works online. Before the large study, we need to do a small ‘feasibility’ study to help us understand if it is feasible to carry out a larger study, and if so, how would we do this?
Who can participate?
We are looking for women (over 18 years old) who have had breast cancer and are struggling with how their body looks (e.g., due to scarring, weight changes, hair loss) or feels and functions (e.g., due to difficulties having sex, loss of sensation, fatigue). We can include women who:
• Have finished active treatment but are awaiting further cosmetic treatment (e.g., awaiting breast reconstruction) if this is not planned to take place during the study.
• Are still on hormone therapy.
• Have metastatic breast cancer and are only on endocrine therapy.
The study is not suitable for women who may have an eating disorder, are still having active treatment, have reconstructive surgery planned during the study period, are having explorations for cancer recurrence, or who have had prophylactic treatment for a gene mutation.
What does the study involve?
People who join the study will be randomly allocated to one of two groups: ABC or standard care. At the moment, there is no formally recommended therapy for women experiencing body distress following treatment for breast cancer. The standard care group will therefore receive a publicly available information booklet developed by Macmillan Cancer Support. The booklet aims to support people who are distressed by treatment-related changes to their body. The ABC group will receive the Macmillan booklet and the ABC course. ABC is a 7-session group-based therapy delivered online by a psychologist and cancer support specialist over 7 weeks, with 8-10 women in each group. There is pre-session reading, and activities during and in-between sessions.
All participants will be in the study for 8 months and will complete a number of questionnaires on 4 occasions (at the beginning of the study, and at 2, 5, and 8 months). These questionnaires will explore participant’s thoughts and feelings relating to their body, as well as their mood, sexual wellbeing, and quality of life. It will take around 15-30 minutes to complete these questionnaires on each occasion, and they can be completed either online or in paper format.
Some participants will also be asked if they would like to take part in an optional interview. The interview will ask about their experience of being in the study. For participants who had the ABC the interview will also ask about their experience of the course.
What are the possible benefits and risks of participating?
Women in the ABC group will hopefully find the course helpful and feel more comfortable in their body. Although women in the standard care group will not receive the ABC course but will have access to the Macmillan booklet that should provide some help to them.
As ABC will be delivered via a video conferencing platform, participants may experience technical issues. Participants will have guidance on how to use the platform prior to the first session and the course facilitators and study team will aim to help with any in-the-moment issues as quickly as possible. As ABC explores a sensitive issue, participants may find sessions upsetting. The experienced facilitators will be able to provide support within the sessions.
Completing questionnaires about body image and sexual wellbeing may cause distress. If this happens, participants can skip any questions, take a pause, or stop completing the questionnaires entirely. Participants will also be signposted to other sources of support.
Where is the study run from?
The study is being run by researchers at the Centre for Appearance Research at the University of the West of England in Bristol (UWE Bristol) (UK)
When is the study starting and how long is it expected to run for?
November 2023 to July 2025
Who is funding the study?
National Institute of Health Research (NIHR) (UK)
Who is the main contact?
The head of the study is Dr Helena Lewis-Smith, Associate Professor of Psychology at UWE Bristol (email: helena.lewis-smith@uwe.ac.uk)
The study manager is Dr Abbie Jones, Research Fellow at UWE Bristol (abbie4.jones@uwe.ac.uk)
Contact information
Public, Scientific, Principal Investigator
Centre for Appearance Research (CAR), College of Health, Science, and Society, University of the West of England, Frenchay Campus
Bristol
BS16 1QY
United Kingdom
 ORCID ID |
0000-0001-9000-8142 |
|---|---|
| Phone | +44 11732 81895 |
| helena.lewis-smith@uwe.ac.uk |
Study information
| Study design | Two-arm randomized feasibility study with an embedded qualitative component to further assess feasibility and acceptability |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Charity/Voluntary sector, Community, Home, Internet/virtual, University/medical school/dental school |
| Study type | Other, Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A feasibility study to inform a Randomised Controlled Trial to evaluate ‘Accepting your Body after Cancer’ (ABC), an online-delivered group-based cognitive behavioural therapy (CBT) body image intervention, for women who have received treatment for breast cancer |
| Study acronym | ABC |
| Study hypothesis | This is a feasibility study to establish the design of a definitive randomised controlled trial. Therefore, there are no hypotheses. |
| Ethics approval(s) |
Approved 05/06/2024, Newcastle North Tyneside 2 (NHS REC) (2 Redman Place, London, E20 1JQ, United Kingdom; +44 207 104 8086; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: REC reference: 24/NE/0092 |
| Condition | Addressing body image distress in patients who have been treated for breast cancer |
| Intervention | Once participants have provided informed consent, and completed baseline data collection (Week 1), they will be randomised to either the intervention or control arm using Sealed Envelope, a web-based randomisation system. Randomisation (at the individual level) will be independent and concealed, using permuted block randomisation. Participants will be randomised to either the intervention or control arm. The control arm will receive the Macmillan Cancer Support psychoeducational body image booklet (freely available and currently the only body-image support available). The intervention arm will receive the Macmillan booklet and the ABC (Accepting your Body after Cancer) programme, a 7-session, CBT group-based programme delivered online. 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. ABC Content Session 1: • Introduction to body image • Personal reflection upon the impact of body image concerns • Exploration of personal goals Session 2: • Introduction to the CBT approach • Physiological symptoms of anxiety • Exploration of body image and self-esteem • Relaxation training Session 3: • Stopping negative body-related self-talk • Developing alternative, balanced thoughts • Planning a self-care activity schedule • Relationship between body function and movement Session 4: • Sociocultural pressures for women in midlife • Internalisation of the youthful-thin ideal • Body comparisons – experimental activity • Body nurture with accepting self-talk Session 5: • Exploration of relationships and intimacy • Managing people’s reactions • Cognitive restructuring process • Physical activity and movement Session 6: • Identifying core beliefs • Modifying mistaken beliefs • Engaging the senses – mindful eating • Relaxation exercise Session 7: • Positive body affirmations • Reducing the chances of a setback • Dealing with a setback • Future plans Macmillan’s freely available psychoeducational body image booklet will be provided to both arms. This 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. Further, given that there is no current ‘treatment-as-usual’ in relation to body image support for women treated for breast cancer, this booklet may constitute the first time that these women have received support specifically relating to body image, and may even reduce distress. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Recruitment measured using total number of participants consented at the end of the study 2. Retention measured using percentage of consented participants completing data collection at baseline, post-intervention, 3-month follow up, 6-month follow up. 3. Data completion rates measured using percentage of missing data at baseline, post-intervention, 3-month follow up, 6-month follow up. 4. Participant feedback on the research process measured using qualitative interviews at baseline, post-intervention, 3-month follow up, 6-month follow up. |
| Secondary outcome measures | 1. Acceptability of ABC programme to participants and facilitators measured using qualitative interviews at post-intervention 2. Establishing the appropriate primary outcome for a full-scale clinical trial: Candidate primary outcome measures for a full-scale RCT measured at baseline, post-intervention, 3-month follow up, 6-month follow up: 2.1. Kessler Psychological Distress Scale (K10) 2.2. Body Appreciation Scale-2 (BAS-2) 2.3. Functional Assessment of Cancer Therapy – Breast (FACT-B Version 4): Breast Cancer Subscale 2.4. Hopwood Body Image Scale 2.5. BREAST-Q: Sexual Well-Being Scale Health economic outcome measures 2.6. Modified version of the Adult Service Use Schedule (AD-SUS) measured at baseline, 3-month follow up, 6-month follow up. 2.7. EQ-5D-5L measured at baseline, post-intervention, 3-month follow up, 6-month follow up. 2.8. Recovering Quality of Life-Utility Index (ReQoL-10) measured at baseline, post-intervention, 3-month follow up, 6-month follow up. 2.9. Work and Social Adjustment Scale (WSAS) measured at baseline, post-intervention, 3-month follow up, 6-month follow up. |
| Overall study start date | 01/11/2023 |
| Overall study end date | 01/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Female |
| Target number of participants | 120 |
| Participant inclusion criteria | 1. Identify as a woman. 2. 18+ years old. 3. 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. 4. 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. 5. Recognises that they are experiencing BID as a result of treatment (regarding how the body looks and/or feels). 6. Has the capacity to provide informed consent or supported informed consent (e.g., with a family member/friend). 7. Has sufficient understanding of English (as the intervention content and measures are currently only available in English). |
| Participant exclusion criteria | 1. 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). 2. Undergoing exploration for cancer recurrence. 3. Has not received a diagnosis of breast cancer e.g., has had prophylactic treatment for a gene mutation (such as risk-reducing mastectomy). 4. Has an eating disorder. 5. Unable to provide informed consent. |
| Recruitment start date | 10/07/2024 |
| Recruitment end date | 17/10/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Sponsor information
University/education
University of the West of England
Frenchay Campus
Bristol
BS16 1QY
England
United Kingdom
| Phone | +44 11732 81670 |
|---|---|
| olena.doran@uwe.ac.uk | |
| Website | http://www.uwe.ac.uk/ |
"ROR" |
https://ror.org/02nwg5t34 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The study protocol and study findings will be published in peer-reviewed journals. Dissemination will target academic, healthcare, and third sector organisation settings, via accessible reports and presentations, knowledge exchange events, social media, conference presentations, and publications. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2 | 23/05/2024 | 26/06/2024 | No | No |
| Protocol article | 22/01/2025 | 29/01/2025 | Yes | No |
Additional files
Editorial Notes
29/01/2025: Publication reference added.
21/10/2024: The recruitment end date was changed from 30/11/2024 to 17/10/2024.
24/06/2024: Trial's existence confirmed by Newcastle North Tyneside 2 (NHS REC).
