Contact information
Type
Scientific
Primary contact
Prof Clare Wilkinson
ORCID ID
Contact details
University of Wales College of Medicine
Academic Unit
Gwenfro Building
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom
+44 (0)1978 316236
c.wilkinson@bangor.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PSI02-69
Study information
Scientific title
Evaluation of guidelines for the referral and management of breast disorders: a pragmatic practice-based randomised trial
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Medical Interview Satisfaction Scale
2. SF36 Health Profile
3. Euroqol Health Status Index
4. Cost Utility Analysis
5. Rates of Referral
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1995
Overall trial end date
01/10/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
30 Group practices
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30 group practices
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/04/1995
Recruitment end date
01/10/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Wales College of Medicine
Wrexham
LL13 7YP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2002 results in: https://doi.org/10.1046/j.1365-2753.2002.00335.x (added 28/11/2019)