Randomized Trial of Follow-up Strategies in Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

968 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

2003-06-30

Brief Summary

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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.

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Detailed Description

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see above

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Follow-up Strategy for Breast Cancer

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No