Randomized Trial of Follow-up Strategies in Breast Cancer

A Randomized Trial of Follow-up Strategies in Breast Cancer

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00156039

Enrollment

968

Registered

2005-09-12

Start date

1997-01-31

Completion date

2003-06-30

Last updated

2009-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Follow-up Strategy, Follow-up Care, Family Physician, Oncologist

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

Interventions

BEHAVIORALFollow-up Strategy for Breast Cancer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
Rate of clinically catastrophic events	Up to 5 yrs after randomization
Rate of Karnofsky performance status < 70	Up to 5 yrs after randomization
Psychosocial well being of patients in remission	Up to 5 yrs after randomization

Secondary

Measure	Time frame
Health Related Quality of Life after recurrence	Up to 5 yrs after randomization
Survival	Up to 5 yrs after randomization
Economic evaluation	Up to 5 yrs after randomization

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026