Status:
COMPLETED
Randomized Trial of Follow-up Strategies in Breast Cancer
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Canadian Breast Cancer Initiative
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether family physician 'routine follow-up care' of women with breast cancer in remission is an acceptable alternative to the existing system of specialist f...
Detailed Description
see above
Eligibility Criteria
Inclusion
- Women with breast cancer on well follow-up at regional cancer centres in Ontario and Manitoba
- Diagnosed at least 12 months previously (range 9-15 months)
- Without evidence of active disease (i.e., stages IIIB and IV excluded)
- Free from any primary treatment complications
Exclusion
- Primary treatment at least 3 months previously, except for continued use of tamoxifen
- Still experiencing complications of primary treatment (patients will become eligible once complications resolve provided they are within the 6 month window)
- Unable to identify an acceptable family physician to provide follow-up
- Language or literacy skills inconsistent with completing questionnaires
- Unable to comply with study protocol including completion of questionnaires
- Previously enrolled in a study which requires continued follow-up in specialist or peripheral clinics
- Actively followed at a cancer centre for another primary cancer
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
968 Patients enrolled
Trial Details
Trial ID
NCT00156039
Start Date
January 1 1997
End Date
June 1 2003
Last Update
July 28 2009
Active Locations (5)
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1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
2
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7M 4J2
3
Ottawa Hospital - Integrate Cancer Program
Ottawa, Ontario, Canada, K1H 8L6
4
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4