Randomised evaluation of a one-stop clinic for breast lump investigation

ISRCTN ISRCTN72127680
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

Department of Psychology
UWE Bristol
St Matthias Campus
Oldbury Court Road
Bristol
BS16 2JP
United Kingdom

Phone +44 (0)117 344 4356
Email nichola.rumsey@uwe.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised evaluation of a one-stop clinic for breast lump investigation
Study objectivesThis 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) studiedBreast cancer
InterventionWomen were randomised to attend either the one-stop or two-stop clinic
Intervention typeOther
Primary outcome measureLevels 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 measuresNot provided at time of registration
Overall study start date01/10/1994
Completion date30/09/1997

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaAll 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 criteriaNone so long as participants were able to complete the assessment
Date of first enrolment01/10/1994
Date of final enrolment30/09/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Psychology
Bristol
BS16 2JP
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.