Randomized Trial of Follow-up Strategies in Breast Cancer

This study has been completed.

First Received: September 8, 2005 Last Updated: July 24, 2009 History of Changes

Sponsors and Collaborators:	Ontario Clinical Oncology Group (OCOG) Canadian Breast Cancer Initiative
Information provided by:	Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:	NCT00156039

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Behavioral: Follow-up Strategy for Breast Cancer	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Trial of Follow-up Strategies in Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	968
Study Start Date:	January 1997
Study Completion Date:	June 2003

Detailed Description:

see above

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156039

Locations

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

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

Canadian Breast Cancer Initiative

Investigators

Study Chair:	Eva Grunfeld, MD	Cancer Care Nova Scotia
Principal Investigator:	Mark Levine, MD	Ontario Clinical Oncology Group

More Information

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. Epub 2006 Jan 17.

Responsible Party:	Cancer Outcomes Research ( Dr. Eva Grunfeld )
Study ID Numbers:	OCOG-1997-FUP, CBCRI-grant-010413
Study First Received:	September 8, 2005
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00156039 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):

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

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009