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 |
| Secondary identifying numbers | N/A |
- 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
Contact information
Dr Lindsay Forbes
Scientific
Scientific
Guy's Campus
9th Floor, Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
| Phone | +44 (0)20 7848 6216 |
|---|---|
| lindsay.forbes@kcl.ac.uk |
Study information
| Study design | Three-arm multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 30/07/2007 |
| Completion date | 30/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Guy's Campus
London
SE1 3QD
United Kingdom
SE1 3QD
United Kingdom
Sponsor information
Institute of Psychiatry (UK)
University/education
University/education
King's College London
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Phone | +44 (0)20 7848 0675 |
|---|---|
| gill.lambert@iop.kcl.ac.uk | |
| Website | http://www.iop.kcl.ac.uk |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- 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 |
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 |
Editorial Notes
07/06/2017: Publication reference added.
