Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/04/2016: No publications found, verifying study status with principal investigator.