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| Improving older women's knowledge and confidence to present early with breast symptoms: a randomised controlled trial of a radiographer-delivered intervention |
| Source of record | UK Trials |
| ISRCTN | ISRCTN31994827 |
| Date ISRCTN assigned | 03/10/2007 |
| Local reference number(s) | N/A |
| Public title | Improving older women's knowledge and confidence to present early with breast symptoms: a randomised controlled trial of a radiographer-delivered intervention |
| Scientific title | |
| Acronym | PEP (Promoting Early Presentation) |
| Disease/condition/study domain | Breast cancer |
| 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. |
| Design/methodology | Three-arm multicentre randomised controlled trial |
| Research ethics review | Approval received from King's College Hospital Research Ethics Committee on the 18th April 2007 (LREC Ref: 07/Q0703/51). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Women aged 67 - 70 years attending National Health Service (NHS) breast screening clinics for final routine mammography. |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 30/07/2007 |
| Anticipated end date | 30/10/2008 |
| Status of trial | Ongoing |
| Target number of participants | 714 |
| Interventions | 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 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 |
| 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 |
| Publications | Review of evidence in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15992567 |
| Sources of funding | Cancer Research UK (UK) |
| Sponsor name | Institute of Psychiatry (UK) |
| Sponsor details | Kings College London De Crespigny Park London United Kingdom SE5 8AF |
| Sponsor telephone | +44 (0)20 7848 0675 |
| Sponsor fax | +44 (0)20 7848 0147 |
| Sponsor email | gill.lambert@iop.kcl.ac.uk |
| Sponsor website | http://www.iop.kcl.ac.uk |
| Contact name | Dr Caroline Burgess |
| Contact details | Cancer Research UK London Psychosocial Group Adamson Centre St Thomas' Hospital London United Kingdom SE1 7EH |
| Contact telephone | +44 (0)20 7188 0908 |
| Contact fax | +44 (0)20 7188 0905 |
| Contact email | caroline.burgess@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN31994827 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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