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Spots Global Cancer Trial Database for Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

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Trial Identification

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

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Pamela J Goodwin, MD, MSc

Affiliation: UHN-Mount Sinai Hospital, Toronto, ON

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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