Expressive writing intervention for body image concerns
| ISRCTN | ISRCTN43117870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43117870 |
| Protocol serial number | 8075 |
| Sponsor | University of Leeds (UK) |
| Funder | Breast Cancer Campaign (UK) |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 27/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Mr Simon Pini
Scientific
Scientific
Level 03, Bexley Wing
St James's Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional process of care trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Feasibility of an expressive writing intervention for older women's body image concerns following surgery for breast cancer |
| Study objectives | The primary aim of this feasibility study is to assess the efficacy and limitations of an expressive writing intervention for body image concerns of older women who have received surgery for breast cancer. The effect of the writing intervention on improving self-esteem, body image, and physical health will be examined using patient-reported outcome measures (PROMS). The secondary aim of the study will be to determine whether individual factors, such as alexithymia and ambivalence over emotional expression moderate any intervention effects. |
| Ethics approval(s) | Leeds East REC, 25/01/2010, ref: 09/H1306/114 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast |
| Intervention | We have baseline measure and a 2 week and 3 month follow up. Consenting patients will be randomised to intervention (expressive writing [EW]) or control (factual writing [FW]) arms. Both arms will complete three twenty minute writing sessions. The intervention arm will write about their deepest thoughts and concerns about cancer and the impact of their disease and treatment on how they feel about their body. The control arm will be given a factual writing task in which they are asked to document how they spent their time the previous day. Alexithymia, ambivalence over emotional expression, physical well-being, and psychological health including self-esteem and body image will be documented by patient self-report using validated instruments. Study entry: single randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
Evaluation of writing method, measured at each time point |
| Key secondary outcome measure(s) |
Moderating effects, measured alongside the writing tasks at baseline. |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target sample size at registration | 60 |
| Total final enrolment | 32 |
| Key inclusion criteria | Eligible are all patients who: 1. Are aged 50 and over, female only 2. Have received surgery for breast cancer (mastectomy with or without reconstruction) in the last 5 years 3. Are currently disease free 4. Are English literate 5. Are able to give informed consent |
| Key exclusion criteria | 1. Overt exhibition of psychopathology or serious cognitive dysfunction which would impede their being able to take part in the study 2. Patients who are deemed too ill by oncology staff |
| Date of first enrolment | 26/02/2010 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Level 03, Bexley Wing
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 27/07/2022 | No | Yes |
Editorial Notes
27/07/2022: Cancer Research UK plain English results summary link and total final enrolment added.
19/12/2017: No publications found in PubMed, verifying study status with principal investigator.
