Condition category
Cancer
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Simon Pini

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8075

Study information

Scientific title

Feasibility of an expressive writing intervention for older women's body image concerns following surgery for breast cancer

Acronym

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

Leeds East REC approved on the 25th January 2010 (ref: 09/H1306/114)

Study design

Single centre randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

Evaluation of writing method, measured at each time point

Secondary outcome measures

Moderating effects, measured alongside the writing tasks at baseline.

Overall trial start date

26/02/2010

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Female

Target number of participants

Planned sample size: 60

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

United Kingdom

Trial participating centre

Level 03, Bexley Wing
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Charity

Funder name

Breast Cancer Campaign (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes