Randomised evaluation of a one-stop clinic for breast lump investigation
| ISRCTN | ISRCTN72127680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72127680 |
| Protocol serial number | C/OPD/17-3-94/CAWTHORN/D; N0467011719 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South West (UK) |
- 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 |
|---|---|
| nichola.rumsey@uwe.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| 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
- United Kingdom
- England
Study participating centre
Department of Psychology
Bristol
BS16 2JP
United Kingdom
BS16 2JP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/10/2019: Internal review.
