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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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 design	Randomised controlled trial
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

Participant type(s)	Patient
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

Department of Psychology

Bristol
BS16 2JP
United Kingdom

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

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

Government

NHS Executive South West (UK)

No information available

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

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

24/10/2019: Internal review.