Randomized Trial of Follow-up Strategies in Breast Cancer

O

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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