NCT00463489

Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Ontario Clinical Oncology Group (OCOG) · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle intervention	Women randomized to the 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.
BEHAVIORAL	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.

Timeline

• Start date: 2007-08-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2007-04-20
• Last updated: 2018-09-26

Locations

21 sites across 2 countries: United States, Canada