Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment weight loss and exercise
Sponsor University of Vermont
Collaborator Dartmouth-Hitchcock Medical Center
Start date October 2012
End date July 2015
Trial size 48 participants
Trial identifier NCT01728506, VCC 1109

Summary

The purpose of this study is to test the effectiveness of a behavioral weight loss and exercise intervention delivered via the internet at different cancer centers in New England. The investigators hypothesize that participants will lose 7% of their body weight. The research is being done because many women who are treated for breast cancer are overweight and treatment for breast cancer is often accompanied by weight gain. Individuals who are overweight may be more likely to have their breast cancer come back. Also women who exercise at least three hours a week seem to have less chance of their cancer coming back. The investigators hope to identify an effective weight loss and exercise intervention for breast cancer survivors that can be easily accessed by many people.

This study is designed to determine the feasibility of conducting a distantly delivered-weight loss and exercise intervention for patients who have been treated for breast cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral weight loss and exercise intervention delivered to overweight/obese breast cancer survivors in three New England locations.

Participants will be recruited from three New England Cancer Centers - the Vermont Cancer Center, Norris Cotton Cancer Center at Dartmouth University and the University of Massachusetts Cancer Center. Participants from each center will undergo baseline assessments that include diet assessment, body measurements (height, weight, etc), a physical activity assessment and be asked to complete a series of questionnaires.

Patients that meet the minimum requirements will be enrolled on the study. They will participate in weekly on-line "chats" about behavioral and diet modifications led by a qualified facilitator. Participants will also engage in increasing amounts of aerobic activity (typically walking) throughout the course of the intervention. The intervention lasts 6 months. At the end of those 6 months, participants will have the same assessments that were collected at baseline. Following the collection of those assessments, participants will have completed the study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Single arm intervention of a 24 week weight loss and exercise intervention.
weight loss and exercise
Internet delivered, behaviorally based weight loss and exercise intervention

Primary Outcomes

Measure
Feasibility
time frame: Change from baseline fesability at 6 months
Change in diet measures
time frame: Change from baseline diet measures at 6 months
Change in anthropometric measures
time frame: Change from baseline anthropometrics at 6 months
Change in active energy expenditure (ie exercise)
time frame: Change from baseline active energy expenditure at 6 months

Secondary Outcomes

Measure
Change in inflammatory biomarkers
time frame: Change from baseline inflammatory biomarkers at 6 months
Change in insulin resistance markers
time frame: Change from baseline insulin resistance markers at 6 months

Eligibility Criteria

Female participants from 21 years up to 69 years old.

Inclusion Criteria: - breast cancer diagnosis - Completion of surgery, chemotherapy +/- radiation for stage I, II, or III breast cancer 2-12 months prior to study initiation - BMI between 27 and 50 - patient self-report of ability to walk for 10 minutes without interruption or pain - access to computer and the internet Exclusion Criteria: - metastatic disease - prior receipt of chemotherapy for other malignancy - pregnancy at the time of study entry - limited food choices due to celiac sprue or inflammatory bowel disease - illiteracy - non-English speaking

Additional Information

Official title An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program
Principal investigator Kim L Dittus, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Vermont.