Randomized Trial of Follow-up Strategies in Breast Cancer

Ontario Clinical Oncology Group (OCOG)

Status and phase

Completed

Phase 4

Conditions

Breast Cancer

Treatments

Behavioral: Follow-up Strategy for Breast Cancer

Study type

Interventional

Funder types

Other

Identifiers

NCT00156039

OCOG-1997-FUP

CBCRI-grant-010413

Details and patient eligibility

About

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.

Full description

see above

Enrollment

968 patients

Sex

Female

Volunteers

No Healthy Volunteers

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