Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lindsay Forbes
ORCID ID
Contact details
Guy's Campus
9th Floor
Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
+44 (0)20 7848 6216
lindsay.forbes@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Improving older women's knowledge and confidence to present early with breast symptoms: a randomised controlled trial of a radiographer-delivered intervention
Acronym
PEP (Promoting Early Presentation)
Study hypothesis
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
King's College Hospital Research Ethics Committee, 18/04/2007, ref: 07/Q0703/51
Study design
Three-arm multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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. 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
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
30/07/2007
Overall trial end date
30/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Women aged 67 - 70 years attending National Health Service (NHS) breast screening clinics for final routine mammography
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
714
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
30/07/2007
Recruitment end date
30/10/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's Campus
London
SE1 3QD
United Kingdom
Sponsor information
Organisation
Institute of Psychiatry (UK)
Sponsor details
King's College London
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0675
gill.lambert@iop.kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
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
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19956161
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21654683
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28583111
Publication citations
-
Results
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.
-
Results
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.