Improving older women's knowledge and confidence to present early with breast symptoms: a randomised controlled trial of a radiographer-delivered intervention

ISRCTN	ISRCTN31994827
DOI	https://doi.org/10.1186/ISRCTN31994827
Protocol serial number	N/A
Sponsor	Institute of Psychiatry (UK)
Funder	Cancer Research UK (CRUK) (UK)

Submission date: 06/08/2007
Registration date: 03/10/2007
Last edited: 07/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-ways-to-encourage-older-women-to-report-breast-symptoms

Contact information

Dr Lindsay Forbes
Scientific

Guy's Campus
9th Floor, Capital House
42 Weston Street
London
SE1 3QD
United Kingdom

Phone	+44 (0)20 7848 6216
Email	lindsay.forbes@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Three-arm multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Improving older women's knowledge and confidence to present early with breast symptoms: a randomised controlled trial of a radiographer-delivered intervention
Study acronym	PEP (Promoting Early Presentation)
Study objectives	The supplementation of optimised usual care with one of two variants of a radiographer-delivered psycho-education intervention will be more effective than optimised usual care alone in improving women's knowledge and confidence to present promptly with breast symptoms. Review of the evidence available in http://www.ncbi.nlm.nih.gov/pubmed/15992567
Ethics approval(s)	King's College Hospital Research Ethics Committee, 18/04/2007, ref: 07/Q0703/51
Health condition(s) or problem(s) studied	Breast cancer
Intervention	All three groups will receive optimised usual care, i.e., a reminder that they are no longer eligible for routine breast screening but may continue to request further breast screening themselves every three years. One group in addition will receive a radiographer-delivered booklet containing educational messages designed to increase women's knowledge and confidence to detect breast changes and to motivate them to present promptly if they discover a breast change. The third group will receive a 10-minute radiographer-delivered interview in addition to the booklet. The interview is based on the key messages of the booklet and provides the opportunity for the radiographer to reinforce and clarify the content of the booklet. The intervention is given just once, duration 10 - 15 minutes for the interview group, 5 minutes or less for booklet-alone and optimised usual care. Follow up consists of a questionnaire sent at 1 month and another at 6 months post-intervention for all groups.
Intervention type	Other
Primary outcome measure(s)	Breast awareness, measured one month post-intervention, based on a composite measure of knowledge of non-lump breast cancer symptoms, knowledge of age-related relative risk and confidence to detect a breast change: each component (knowledge/risk/confidence) is given equal weighting and contributes one point to the total score (range 0 to 3), as follows: 1. Non-lump knowledge: 1.1. Score 1 if 5 - 9 symptoms identified 1.2. Score 0 if 0 - 4 symptoms identified 2. Relative risk: 2.1. Score 1 if identify old age group as most at risk 2.2. Score 0 if do not identify old age group as most at risk 3. Confidence: 3.1. Score 1 if check breasts at least once a week/month 3.2. Score 0 if check breasts at least once every six months or less
Key secondary outcome measure(s)	Secondary measures are changes at one month and six months post intervention in: 1. Knowledge of breast cancer symptoms (score 0 - 11) 2. Knowledge of relative risk (in the next year who is most likely to get breast cancer? [response categories: a 30 year old woman/a 50 year old woman/a 70 year old woman/a woman of any age]) 3. Knowledge of absolute risk (how many women will develop breast cancer in their lifetime? [response categories: 1 in 3/1 in 9/1 in 100/1 in 1000]) 4. Confidence to detect a breast change (how often do you check your breasts? [response categories: at least once a week/at least once a month/at least every six months/rarely or never]) 5. Breast awareness, measured six months post intervention, based on a composite measure of knowledge of non-lump breast cancer symptoms, knowledge of age-related relative risk, and confidence to detect a breast change
Completion date	30/10/2008

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target sample size at registration	714
Key inclusion criteria	Women aged 67 - 70 years attending National Health Service (NHS) breast screening clinics for final routine mammography
Key exclusion criteria	1. Any significant disease or disorder that affects ability to consent or participate 2. Insufficient understanding of the English language, or language difficulties 3. Participant going overseas during the six-month study period
Date of first enrolment	30/07/2007
Date of final enrolment	30/10/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Guy's Campus

London
SE1 3QD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/12/2009		Yes	No
Results article	results	28/06/2011		Yes	No
Results article	results	05/06/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/06/2017: Publication reference added.