Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/05/2012
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

Dr Diana Harcourt

ORCID ID

Contact details

Department of Psychology
UWE Bristol
St Matthias Campus
Oldbury Court Road
Bristol
BS16 2JP
United Kingdom
+44 (0)117 344 4356
nichola.rumsey@uwe.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C/OPD/17-3-94/CAWTHORN/D; N0467011719

Study information

Scientific title

Acronym

Study hypothesis

This will be through a RCT in comparison with a conventional model of care involving two clinic attendances and a separate mammography.

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

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

Women were randomised to attend either the one-stop or two-stop clinic

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/1994

Overall trial end date

30/09/1997

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

None so long as participants were able to complete the assessment

Recruitment start date

01/10/1994

Recruitment end date

30/09/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychology
Bristol
BS16 2JP
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (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

1. Harcourt, D., Ambler, N., Rumsey, N. & Cawthorn, S. J., (1998). Evaluation Of A One-Stop Breast Lump Clinic: A Randomised Controlled Trial. The Breast, vol 7, no. 6, p 314-319.
2. Harcourt, D., Rumsey, N. & Ambler, N. (1999). Same-Day Diagnosis Of Symptomatic Breast Problems: Psychological Impact And Coping Strategies. Psychology, Health & Medicine, vol 4, no 1, p57-71.

Publication citations

Additional files

Editorial Notes