An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors (iWEB)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: Weight Loss and Exercise |
| Study Type: | Interventional |
| 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 ]Fesability 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 exependiture (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
| Estimated Enrollment: | 48 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 21 Years to 69 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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 40
- 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
Contacts and Locations| Contact: Kim L Dittus, MD PhD | 802-656-5487 ext x | kim.dittus@vtmednet.org |
| Contact: Karen Wilson, BS | 802-656-4101 | karen.wilson@uvm.edu |
| United States, Massachusetts | |
| University of Massachusetts | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| Contact: Susan Bakke, BS susan.bakke@umass.edu | |
| 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 christina.l.donnelly@hitchcock.org | |
| 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 karen.wilson@uvm.edu | |
| Principal Investigator: Kim L Dittus, MD, PhD | |
| Principal Investigator: | Kim L Dittus, MD PhD | University of Vermont |
More Information
No publications provided
| Responsible Party: | Kim Dittus, Assistant Professor, University of Vermont |
| ClinicalTrials.gov Identifier: | NCT01728506 History of Changes |
| Other Study ID Numbers: | VCC 1109 |
| Study First Received: | July 24, 2012 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Vermont:
|
breast cancer survivor Weight loss Exercise |
Additional relevant MeSH terms:
|
Breast Neoplasms Weight Loss Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013