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

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: Breast Cancer
• Intervention / Treatment: Behavioral: Weight Loss and Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	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)	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	Change in Il-6, hsCRP before and after the intervention	Change from baseline inflammatory biomarkers at 6 months
Change in insulin resistance markers	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

• 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

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: Exercise; Weight loss; breast cancer survivor
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Body Weight; Body Weight Changes; Breast Neoplasms; Weight Loss
• Other Study ID Numbers: VCC 1109