Randomized Trial of Follow-up Strategies in Breast Cancer

July 24, 2009 updated by: Ontario Clinical Oncology Group (OCOG)

A Randomized Trial of Follow-up Strategies in Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Behavioral: Follow-up Strategy for Breast Cancer

Detailed Description

see above

Study Type

Interventional

Enrollment (Actual)

968

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Juravinski Cancer Centre
  - Kingston, Ontario, Canada, K7M 4J2
    - Kingston Regional Cancer Centre
  - Ottawa, Ontario, Canada, K1H 8L6
    - Ottawa Hospital - Integrate Cancer Program
  - Thunder Bay, Ontario, Canada, P7B 6V4
    - Thunder Bay Regional Health Sciences Centre
  - Toronto, Ontario, Canada, M4N 3M5
    - Toronto Sunnybrook Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Canadian Breast Cancer Initiative

Investigators

Study Chair: Eva Grunfeld, MD, Cancer Care Nova Scotia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Grunfeld E, Levine MN, Julian JA, Coyle D, Szechtman B, Mirsky D, Verma S, Dent S, Sawka C, Pritchard KI, Ginsburg D, Wood M, Whelan T. Randomized trial of long-term follow-up for early-stage breast cancer: a comparison of family physician versus specialist care. J Clin Oncol. 2006 Feb 20;24(6):848-55. doi: 10.1200/JCO.2005.03.2235. Epub 2006 Jan 17.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Primary Completion

December 7, 2022

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria