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

Breast Cancer Clinical Trial

— iWEB  

Official title:

An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01728506
• Other study ID #: VCC 1109
• Status: Active, not recruiting
• Phase: N/A
• First received: July 24, 2012
• Last updated: May 15, 2015
• Start date: October 2012
• Est. completion date: July 2015

Study information

• Verified date: May 2015
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 69 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Weight Loss

Intervention

Behavioral:
• Weight Loss and Exercise
Internet delivered, behaviorally based weight loss and exercise intervention

Locations

Country	Name	City	State
United States	Unviersity of Vermont/Fletcher Allen Health Care	Burlington	Vermont
United States	Dartmouth Hitchcock Medical Center	Hannover	New Hampshire
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont	Dartmouth-Hitchcock Medical Center, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from baseline fesability at 6 months	No
Primary	Change in diet measures	Efficacy will be measured using total calories and fat grams before and after the intervention	Change from baseline diet measures at 6 months	No
Primary	Change in anthropometric measures	Change in Weight, BMI, body fat percentage before and after the intervention	Change from baseline anthropometrics at 6 months	No
Primary	Change in active energy expenditure (ie exercise)	exercise will be measured using an accelerometer before and after the intervention	Change from baseline active energy expenditure at 6 months	No
Secondary	Change in inflammatory biomarkers	Change in Il-6, hsCRP before and after the intervention	Change from baseline inflammatory biomarkers at 6 months	No
Secondary	Change in insulin resistance markers	Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention	Change from baseline insulin resistance markers at 6 months	No