Randomized Trial of Follow-up Strategies in Breast Cancer
Phase 4
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT00156039
- Lead Sponsor
- Ontario Clinical Oncology Group (OCOG)
- 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 follow-up. Primary outcome measure are event rates of oncological catastrophes and quality of life.
- Detailed Description
see above
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 968
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of clinically catastrophic events Up to 5 yrs after randomization Psychosocial well being of patients in remission Up to 5 yrs after randomization Rate of Karnofsky performance status < 70 Up to 5 yrs after randomization
- Secondary Outcome Measures
Name Time Method Health Related Quality of Life after recurrence Up to 5 yrs after randomization Economic evaluation Up to 5 yrs after randomization Survival Up to 5 yrs after randomization
Trial Locations
- Locations (5)
Toronto Sunnybrook Hospital
🇨🇦Toronto, Ontario, Canada
Ottawa Hospital - Integrate Cancer Program
🇨🇦Ottawa, Ontario, Canada
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
🇨🇦Thunder Bay, Ontario, Canada