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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Kim Dittus, University of Vermont.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01728506
First Posted: November 19, 2012
Last Update Posted: May 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dartmouth-Hitchcock Medical Center
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Kim Dittus, University of Vermont
  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: Intervention Model: Single Group Assignment
Masking: None (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 Kim Dittus, University of Vermont:

Primary Outcome Measures:
  • 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 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 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 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


Secondary Outcome Measures:
  • 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 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


Estimated Enrollment: 48
Study Start Date: October 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 69 Years   (Adult, Senior)
Sexes 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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728506


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

Responsible Party: Kim Dittus, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT01728506     History of Changes
Other Study ID Numbers: VCC 1109
First Submitted: July 24, 2012
First Posted: November 19, 2012
Last Update Posted: May 18, 2015
Last Verified: May 2015

Keywords provided by Kim Dittus, 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


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