Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463489
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2007-04-19
Brief Title:
Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
Sponsor:
Ontario Clinical Oncology Group OCOG
Organization:
Ontario Clinical Oncology Group OCOG
Study Overview
Official Title:
Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LISA
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 kgm2 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 kgm2 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 kcalday 20 calories fat and increasing their moderate physical activity to 150-200 minutesweek 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 2150 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 005 2-tailed to detect a hazard ratio HR for DFS of 074-076 in the weight loss intervention arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None