Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Mail-basedBehavioral: Lifestyle intervention
- Registration Number
- NCT00463489
- Lead Sponsor
- Ontario Clinical Oncology Group (OCOG)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 338
- Post-menopausal woman with a diagnosis of invasive breast cancer (T1-3,pN0-2,M0) for which definitive surgery was performed during the previous 36 months.
- On adjuvant hormonal therapy with letrozole at time of randomization (either as initial adjuvant hormonal therapy or after a switch from tamoxifen or other hormonal therapy).
- BMI ≥ 24 kg/m2.
- Medical, surgical or radiation oncologist agrees to subject participation in a diet and physical activity program.
- Life expectancy less than five years.
- Self-reported inability to walk at least 2 blocks (at any pace).
- Insulin requiring diabetes (telephone directed diet and physical activity changes would be difficult in this population without close coordination with the treating physician). Non-insulin requiring diabetics are eligible for the study.
- Serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
- Psychiatric disorders or conditions that, in the opinion of the investigator, would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
- Patients on aromatase inhibitors other than letrozole at study entry.
- Known recurrence of breast cancer (local, regional or distant) at any time prior to study entry.
- History of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Prior in situ cancer of the breast is not a reason for exclusion.
- Patients not fluent in either English or French (spoken and written).
- Patient unwilling or unable to provide informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mail-based Mail-based Participants will receive a standardized mail-based intervention focussing on healthy living. This will include mailings at study entry as well as a two year subscription to health magazine. Individualized Lifestyle Intervention Lifestyle intervention Women randomized to the individualized lifestyle intervention arm will receive an intervention program that consists of individual weight loss, diet and physical activity goals, incorporated into a 2 year standardized, structured telephone and mail-based intervention. In addition to diet and physical activity, the intervention will address behavioural and motivational issues relating to weight management including maintaining motivation, overcoming obstacles to success, relapse prevention, emotional distress, stress and time management.
- Primary Outcome Measures
Name Time Method Disease-free survival 8 years
- Secondary Outcome Measures
Name Time Method Overall survival 8 years Distant disease-free survival 8 years Weight at 6, 12, 24, 36, 48 and 60 months compared to baseline 5 years Health-related quality of life at 6, 12, 24, 36, 48 and 60 months compared to baseline 5 years Other medical endpoints such as diabetes, cardiovascular disease, arthritis, fasting biomarkers at 12 months compared to baseline (for women participating in a biospecimen substudy) 8 years Compliance with study procedures. 8 years
Trial Locations
- Locations (21)
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Sunnybrook Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Beth Israel Deaconess Medical Centre
🇺🇸Boston, Massachusetts, United States
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Grand River Regional Cancer Centere
🇨🇦Kitchener, Ontario, Canada
Ottawa Hospital Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Trillium Healthcare Centre
🇨🇦Toronto, Ontario, Canada
Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Bcca - Csi
🇨🇦Kelowna, British Columbia, Canada
Cambridge Memorial Hospital
🇨🇦Cambridge, Ontario, Canada
Niagara Health System
🇨🇦St. Catharines, Ontario, Canada
Thunder Bay Regional Health Science Centre
🇨🇦Thunder Bay, Ontario, Canada
London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Algoma District Cancer Program
🇨🇦Sault Ste. Marie, Ontario, Canada
Scarborough Hospital
🇨🇦Scarborough, Ontario, Canada
Hopital Charles LeMoyne
🇨🇦Greenfield Park, Quebec, Canada
CHUM - Hotel Dieu de Montreal
🇨🇦Montreal, Quebec, Canada