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Randomized Trial of Follow-up Strategies in Breast Cancer

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ClinicalTrials.gov Identifier: NCT00156039
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 28, 2009
Sponsor:
Collaborator:
Canadian Breast Cancer Initiative
Information provided by:
Ontario Clinical Oncology Group (OCOG)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Follow-up Strategy for Breast Cancer Phase 4

Detailed Description:
see above
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 968 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Follow-up Strategies in Breast Cancer
Study Start Date : January 1997
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Rate of clinically catastrophic events [ Time Frame: Up to 5 yrs after randomization ]
  2. Rate of Karnofsky performance status < 70 [ Time Frame: Up to 5 yrs after randomization ]
  3. Psychosocial well being of patients in remission [ Time Frame: Up to 5 yrs after randomization ]

Secondary Outcome Measures :
  1. Health Related Quality of Life after recurrence [ Time Frame: Up to 5 yrs after randomization ]
  2. Survival [ Time Frame: Up to 5 yrs after randomization ]
  3. Economic evaluation [ Time Frame: Up to 5 yrs after randomization ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156039


Locations
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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
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Study Chair: Eva Grunfeld, MD Cancer Care Nova Scotia
Principal Investigator: Mark Levine, MD Ontario Clinical Oncology Group (OCOG)
More Information
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Publications of Results:

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Responsible Party: Dr. Eva Grunfeld, Cancer Outcomes Research
ClinicalTrials.gov Identifier: NCT00156039    
Other Study ID Numbers: OCOG-1997-FUP
CBCRI-grant-010413
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: July 2009
Keywords provided by Ontario Clinical Oncology Group (OCOG):
Breast Cancer
Follow-up Strategy
Follow-up Care
Family Physician
Oncologist
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases