Expressive writing intervention for body image concerns

ISRCTN	ISRCTN43117870
DOI	https://doi.org/10.1186/ISRCTN43117870
Secondary identifying numbers	8075

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-writing-experience-women-after-surgery-breast-cancer

Contact information

Mr Simon Pini
Scientific

Level 03, Bexley Wing
St James's Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom

Study information

Study design	Single centre randomised interventional process of care trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Feasibility of an expressive writing intervention for older women's body image concerns following surgery for breast cancer
Study hypothesis	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
Condition	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	Evaluation of writing method, measured at each time point
Secondary outcome measures	Moderating effects, measured alongside the writing tasks at baseline.
Overall study start date	26/02/2010
Overall study end date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	Planned sample size: 60
Total final enrolment	32
Participant 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
Participant 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
Recruitment start date	26/02/2010
Recruitment end date	01/09/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Level 03, Bexley Wing

Leeds
LS9 7TF
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom

Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Charity

Breast Cancer Campaign (UK)
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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?
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.