An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors (iWEB)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program|
- Feasibility [ Time Frame: Change from baseline fesability at 6 months ] [ Designated as safety issue: No ]Feasibility will be determined by length of time required to obtain approval at all three sites, Numbers approached vs. numbers who participate in the study.
- Change in diet measures [ Time Frame: Change from baseline diet measures at 6 months ] [ Designated as safety issue: No ]Efficacy will be measured using total calories and fat grams before and after the intervention
- Change in anthropometric measures [ Time Frame: Change from baseline anthropometrics at 6 months ] [ Designated as safety issue: No ]Change in Weight, BMI, body fat percentage before and after the intervention
- Change in active energy expenditure (ie exercise) [ Time Frame: Change from baseline active energy expenditure at 6 months ] [ Designated as safety issue: No ]exercise will be measured using an accelerometer before and after the intervention
- Change in inflammatory biomarkers [ Time Frame: Change from baseline inflammatory biomarkers at 6 months ] [ Designated as safety issue: No ]Change in Il-6, hsCRP before and after the intervention
- Change in insulin resistance markers [ Time Frame: Change from baseline insulin resistance markers at 6 months ] [ Designated as safety issue: No ]Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Weight Loss & Exercise
Single arm intervention of a 24 week weight loss and exercise intervention.
Behavioral: Weight Loss and Exercise
Internet delivered, behaviorally based weight loss and exercise intervention
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728506
|Contact: Kim L Dittus, MD PhD||802-656-5487 ext firstname.lastname@example.org|
|Contact: Karen Wilson, BSemail@example.com|
|United States, Massachusetts|
|University of Massachusetts||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Susan Bakke, BS firstname.lastname@example.org|
|Principal Investigator: Ockene Judith, PhD|
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center||Recruiting|
|Hannover, New Hampshire, United States, 03755|
|Contact: Christina L Donnely, BS email@example.com|
|Principal Investigator: Mary Chamberlain, MD|
|United States, Vermont|
|Unviersity of Vermont/Fletcher Allen Health Care||Not yet recruiting|
|Burlington, Vermont, United States, 05405|
|Contact: Karen Wilson 802-656-4101 firstname.lastname@example.org|
|Principal Investigator: Kim L Dittus, MD, PhD|
|Principal Investigator:||Kim L Dittus, MD PhD||University of Vermont|