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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss and Exercise
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer survivor, Weight loss, Exercise

Eligibility Criteria

21 Years - 69 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Massachusetts
  • Dartmouth Hitchcock Medical Center
  • Unviersity of Vermont/Fletcher Allen Health Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight Loss & Exercise

Arm Description

Single arm intervention of a 24 week weight loss and exercise intervention.

Outcomes

Primary Outcome Measures

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 in diet measures
Efficacy will be measured using total calories and fat grams before and after the intervention
Change in anthropometric measures
Change in Weight, BMI, body fat percentage before and after the intervention
Change in active energy expenditure (ie exercise)
exercise will be measured using an accelerometer before and after the intervention

Secondary Outcome Measures

Change in inflammatory biomarkers
Change in Il-6, hsCRP before and after the intervention
Change in insulin resistance markers
Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention

Full Information

First Posted
July 24, 2012
Last Updated
May 15, 2015
Sponsor
University of Vermont
Collaborators
Dartmouth-Hitchcock Medical Center, University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT01728506
Brief Title
An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors
Acronym
iWEB
Official Title
An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Dartmouth-Hitchcock Medical Center, University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer survivor, Weight loss, Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight Loss & Exercise
Arm Type
Experimental
Arm Description
Single arm intervention of a 24 week weight loss and exercise intervention.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss and Exercise
Intervention Description
Internet delivered, behaviorally based weight loss and exercise intervention
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
Change from baseline fesability at 6 months
Title
Change in diet measures
Description
Efficacy will be measured using total calories and fat grams before and after the intervention
Time Frame
Change from baseline diet measures at 6 months
Title
Change in anthropometric measures
Description
Change in Weight, BMI, body fat percentage before and after the intervention
Time Frame
Change from baseline anthropometrics at 6 months
Title
Change in active energy expenditure (ie exercise)
Description
exercise will be measured using an accelerometer before and after the intervention
Time Frame
Change from baseline active energy expenditure at 6 months
Secondary Outcome Measure Information:
Title
Change in inflammatory biomarkers
Description
Change in Il-6, hsCRP before and after the intervention
Time Frame
Change from baseline inflammatory biomarkers at 6 months
Title
Change in insulin resistance markers
Description
Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention
Time Frame
Change from baseline insulin resistance markers at 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim L Dittus, MD PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Hannover
State/Province
New Hampshire
ZIP/Postal Code
03755
Country
United States
Facility Name
Unviersity of Vermont/Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

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

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