Randomised evaluation of a one-stop clinic for breast lump investigation
ISRCTN | ISRCTN72127680 |
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DOI | https://doi.org/10.1186/ISRCTN72127680 |
Secondary identifying numbers | C/OPD/17-3-94/CAWTHORN/D; N0467011719 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 24/10/2019
- 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
Dr Diana Harcourt
Scientific
Scientific
Department of Psychology
UWE Bristol
St Matthias Campus
Oldbury Court Road
Bristol
BS16 2JP
United Kingdom
Phone | +44 (0)117 344 4356 |
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nichola.rumsey@uwe.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Randomised evaluation of a one-stop clinic for breast lump investigation |
Study objectives | This will be through a RCT in comparison with a conventional model of care involving two clinic attendances and a separate mammography. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Breast cancer |
Intervention | Women were randomised to attend either the one-stop or two-stop clinic |
Intervention type | Other |
Primary outcome measure | Levels of anxiety, depression, quality of life. Styles of coping were compared in the 2 clinic groups, at first attendence, 6 days and 8 weeks after |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/10/1994 |
Completion date | 30/09/1997 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | All women with a symptomatic breast condition referred for examination at a specialist breast clinic - either the same day diagnosis (1-stop clinic) or a wait for results clinic (2-stop clinic) |
Key exclusion criteria | None so long as participants were able to complete the assessment |
Date of first enrolment | 01/10/1994 |
Date of final enrolment | 30/09/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Psychology
Bristol
BS16 2JP
United Kingdom
BS16 2JP
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South West (UK)
No information available
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 | 01/12/1998 | Yes | No | |
Results article | results | 01/02/1999 | Yes | No |
Editorial Notes
24/10/2019: Internal review.