Randomized Trial of Follow-up Strategies in Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Randomized Trial of Follow-up Strategies in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156039
• Other study ID #: OCOG-1997-FUP
• Secondary ID: CBCRI-grant-0104
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: July 24, 2009
• Start date: January 1997
• Est. completion date: June 2003

Study information

• Verified date: July 2009
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 968
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Follow-up Strategy for Breast Cancer

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Kingston Regional Cancer Centre	Kingston	Ontario
Canada	Ottawa Hospital - Integrate Cancer Program	Ottawa	Ontario
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Toronto Sunnybrook Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Canadian Breast Cancer Initiative

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 speciali — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinically catastrophic events		Up to 5 yrs after randomization
Primary	Rate of Karnofsky performance status < 70		Up to 5 yrs after randomization
Primary	Psychosocial well being of patients in remission		Up to 5 yrs after randomization
Secondary	Health Related Quality of Life after recurrence		Up to 5 yrs after randomization
Secondary	Survival		Up to 5 yrs after randomization
Secondary	Economic evaluation		Up to 5 yrs after randomization