An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors (iWEB)

May 15, 2015 updated by: Kim Dittus, University of Vermont

An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts
    • New Hampshire
      • Hannover, New Hampshire, United States, 03755
        • Dartmouth Hitchcock Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Unviersity of Vermont/Fletcher Allen Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: Change from baseline fesability at 6 months
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 from baseline fesability at 6 months
Change in diet measures
Time Frame: Change from baseline diet measures at 6 months
Efficacy will be measured using total calories and fat grams before and after the intervention
Change from baseline diet measures at 6 months
Change in anthropometric measures
Time Frame: Change from baseline anthropometrics at 6 months
Change in Weight, BMI, body fat percentage before and after the intervention
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
exercise will be measured using an accelerometer before and after the intervention
Change from baseline active energy expenditure at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inflammatory biomarkers
Time Frame: Change from baseline inflammatory biomarkers at 6 months
Change in Il-6, hsCRP before and after the intervention
Change from baseline inflammatory biomarkers at 6 months
Change in insulin resistance markers
Time Frame: Change from baseline insulin resistance markers at 6 months
Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention
Change from baseline insulin resistance markers at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

Dartmouth-Hitchcock Medical Center
University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Kim L Dittus, MD PhD, University of Vermont

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

July 24, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 19, 2012

Study Record Updates

Last Update Posted (Estimate)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 15, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCC 1109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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