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Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

NCT00463489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2018-09-26

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pamela J Goodwin, MD, MSc · UHN-Mount Sinai Hospital, Toronto, ON

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00463489 on ClinicalTrials.gov