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

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ClinicalTrials.gov Identifier: NCT01728506
Recruitment Status : Unknown
Verified May 2015 by Kim Dittus, University of Vermont.
Recruitment status was:  Active, not recruiting
First Posted : November 19, 2012
Last Update Posted : May 18, 2015
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Kim Dittus, University of Vermont

July 24, 2012
November 19, 2012
May 18, 2015
October 2012
July 2015   (Final data collection date for primary outcome measure)
  • 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
  • Feasibility [ Time Frame: Change from baseline fesability at 6 months ]
    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 ]
    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 exependiture (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
Complete list of historical versions of study NCT01728506 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors
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.

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Breast Cancer
Behavioral: Weight Loss and Exercise
Internet delivered, behaviorally based weight loss and exercise intervention
Experimental: Weight Loss & Exercise
Single arm intervention of a 24 week weight loss and exercise intervention.
Intervention: Behavioral: Weight Loss and Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
48
Same as current
July 2015
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
21 Years to 69 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01728506
VCC 1109
Yes
Not Provided
Not Provided
Kim Dittus, University of Vermont
University of Vermont
  • Dartmouth-Hitchcock Medical Center
  • University of Massachusetts, Worcester
Principal Investigator: Kim L Dittus, MD PhD University of Vermont
University of Vermont
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP