Plain English Summary
Dr Lindsay Forbes
42 Weston Street
+44 (0)20 7848 6216
PEP (Promoting Early Presentation)
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
Approval received from King's College Hospital Research Ethics Committee on the 18th April 2007 (LREC Ref: 07/Q0703/51).
Three-arm multicentre randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
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.
Primary outcome measures
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
3.1. 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
Secondary outcome measures
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
Overall trial start date
Overall trial end date
Participant inclusion criteria
Women aged 67 - 70 years attending National Health Service (NHS) breast screening clinics for final routine mammography.
Target number of participants
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Cancer Research UK (CRUK) (UK)
Funding Body Type
private sector organisation
Funding Body Subtype
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
Linsell L, Forbes LJ, Kapari M, Burgess C, Omar L, Tucker L, Ramirez AJ, A randomised controlled trial of an intervention to promote early presentation of breast cancer in older women: effect on breast cancer awareness., Br. J. Cancer, 2009, 101 Suppl 2, S40-8, doi: 10.1038/sj.bjc.6605389.
Forbes LJ, Linsell L, Atkins L, Burgess C, Tucker L, Omar L, Ramirez AJ, A promoting early presentation intervention increases breast cancer awareness in older women after 2 years: a randomised controlled trial., Br. J. Cancer, 2011, 105, 1, 18-21, doi: 10.1038/bjc.2011.205.