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Brief Title: Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
Official Title: Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
Study ID: NCT00463489
Brief Summary: The primary objective of this trial is to evaluate the effect of the addition of a 2 year, centrally delivered individualized, telephone-based lifestyle intervention focusing on weight management to a mailed educational intervention on Disease Free Survival in post-menopausal women with early stage breast cancer (hormone receptor positive), BMI ≥24-\<40 kg/m2, who are receiving standard letrozole adjuvant therapy.
Detailed Description: The primary objective of this trial is to evaluate the effect of the addition of a 2 year, centrally delivered individualized, telephone-based lifestyle intervention focusing on weight management to a mailed educational intervention on Disease Free Survival in post-menopausal women with early stage breast cancer (hormone receptor positive), BMI ≥24-\<40 kg/m2, who are receiving standard letrozole adjuvant therapy. The telephone intervention will involve 19 phone calls, as well as mailings and a participant manual; women will be asked to lose up to 10% of their weight by reducing their caloric and fat intake (by 500-1000 kcal/day, 20% calories fat) and increasing their moderate physical activity (to 150-200 minutes/week). Secondary outcomes include overall survival, distant disease-free survival, weight change, health-related quality of life (HRQOL), selected non-cancer medical events and biologic factors (notably insulin). Approximately 2,150 women will be enrolled; follow-up will continue until target event rates have been met (anticipated 4-6 years after completion of the intervention). This sample size will provide 80% power (type 1 error 0.05 2-tailed) to detect a hazard ratio (HR) for DFS of 0.74-0.76 in the weight loss intervention arm.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center, Torrance, California, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Centre, Boston, Massachusetts, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Bcca - Csi, Kelowna, British Columbia, Canada
Cambridge Memorial Hospital, Cambridge, Ontario, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Grand River Regional Cancer Centere, Kitchener, Ontario, Canada
London Regional Cancer Centre, London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Algoma District Cancer Program, Sault Ste. Marie, Ontario, Canada
Scarborough Hospital, Scarborough, Ontario, Canada
Niagara Health System, St. Catharines, Ontario, Canada
Thunder Bay Regional Health Science Centre, Thunder Bay, Ontario, Canada
Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
St. Michael's Hospital, Toronto, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Trillium Healthcare Centre, Toronto, Ontario, Canada
Windsor Regional Cancer Centre, Windsor, Ontario, Canada
Hopital Charles LeMoyne, Greenfield Park, Quebec, Canada
CHUM - Hotel Dieu de Montreal, Montreal, Quebec, Canada
Name: Pamela J Goodwin, MD, MSc
Affiliation: UHN-Mount Sinai Hospital, Toronto, ON
Role: PRINCIPAL_INVESTIGATOR