ISRCTN ISRCTN54211123
DOI https://doi.org/10.1186/ISRCTN54211123
Protocol serial number RHC18065
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
Funder NHS Executive North West (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
05/03/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Andrew Baildam
Scientific

South Manchester University Hospitals NHS Trust
Department of Surgery
Nell Lane
West Didsbury
Manchester
M20 2LR
United Kingdom

Phone +44 (0)161 291 3842
Email abc@email.com

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleSpecialist nurse-led clinics for breast cancer patients
Study objectivesHow effective are nurse-led follow-up clinics for women with breast cancer?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
Intervention1. Traditional surgeon-led out-patient follow-up clinics
2. Specialist breast nurse-led clinic
Intervention typeOther
Primary outcome measure(s)

1. Spielberger State and Anxiety Scale
2. Fallowfield Q Scales
3. EORTC QLQ C30 and BC modules will be used to assess communication, body image, sexual functioning and global quality of life

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/08/2000

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration354
Key inclusion criteriaWomen treated for breast cancer
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/08/1998
Date of final enrolment01/08/2000

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

South Manchester University Hospitals NHS Trust
Manchester
M20 2LR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

05/03/2020: No publications found, verifying study status with principal investigator.