Evaluation of guidelines for the referral and management of breast disorders: a pragmatic practice-based randomised trial
| ISRCTN | ISRCTN56750811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56750811 |
| Protocol serial number | PSI02-69 |
| Sponsor | Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK) |
| Funder | NHS Primary and Secondary Care Interface National Research and Development Programme (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 28/11/2019
- 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
Not provided at time of registration
Contact information
Prof Clare Wilkinson
Scientific
Scientific
University of Wales College of Medicine
Academic Unit
Gwenfro Building
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom
| Phone | +44 (0)1978 316236 |
|---|---|
| c.wilkinson@bangor.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of guidelines for the referral and management of breast disorders: a pragmatic practice-based randomised trial |
| Study objectives | The aim of this project is to implement and evaluate existing national guidelines for referral and management of breast disorders. Evaluation will be via a pragmatic practice based randomised trial. The guidelines include algorithms for the management of breast pain/diffuse lumpiness and breast lumps. A preliminary study will measure women's and GP's perceptions of risk for these presentations and the practical basis for a risk communication package will be developed. This will be followed by a practice based randomised trial in Wales. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Medical Interview Satisfaction Scale |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | 30 Group practices |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/04/1995 |
| Date of final enrolment | 01/10/1999 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
University of Wales College of Medicine
Wrexham
LL13 7YP
United Kingdom
LL13 7YP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/08/2002 | 28/11/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/11/2019: Publication reference added.
15/04/2016: No publications found, verifying study status with principal investigator.
