Clinical trial NCT00156039: Randomized Trial of Follow-up Strategies in Breast Cancer
Official title: A Randomized Trial of Follow-up Strategies in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast Cancer
Follow-up Strategy
Follow-up Care
Family Physician
Oncologist
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Initiative
First posted: 2005-09-12
Enrollment: 968
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: see above

Eligibility 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

Primary outcomes:
measure: Rate of clinically catastrophic events
timeFrame: Up to 5 yrs after randomization
measure: Rate of Karnofsky performance status < 70
timeFrame: Up to 5 yrs after randomization
measure: Psychosocial well being of patients in remission
timeFrame: Up to 5 yrs after randomization
Secondary outcomes:
measure: Health Related Quality of Life after recurrence
timeFrame: Up to 5 yrs after randomization
measure: Survival
timeFrame: Up to 5 yrs after randomization
measure: Economic evaluation
timeFrame: Up to 5 yrs after randomization
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital - Integrate Cancer Program
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Hospital
state: Ontario
Study officials:
affiliation: Cancer Care Nova Scotia
name: Eva Grunfeld, MD
role: STUDY_CHAIR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.