Randomized Trial of Follow-up Strategies in Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Canadian Breast Cancer Initiative
Information provided by:
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00156039
First received: September 8, 2005
Last updated: July 24, 2009
Last verified: July 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Trial of Follow-up Strategies in Breast Cancer

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Breast Cancer
Follow-up Strategy
Follow-up Care
Family Physician
Oncologist

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014