Trial record 1 of 1 for:    NCT01728506
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An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors (iWEB)

This study is currently recruiting participants.
Verified January 2013 by University of Vermont
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Kim Dittus, University of Vermont
ClinicalTrials.gov Identifier:
NCT01728506
First received: July 24, 2012
Last updated: January 7, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728506

Contacts
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

Locations
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         
Sponsors and Collaborators
University of Vermont
Dartmouth-Hitchcock Medical Center
University of Massachusetts, Worcester
Investigators
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 April 16, 2014