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

NCT01728506 | Unknown DMC

• 1 other identifier: VCC 1109
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

breast cancer survivor; Weight loss; Exercise

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Change in anthropometric measures

  Change in Weight, BMI, body fat percentage before and after the intervention

  Change from baseline anthropometrics at 6 months

• 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

Secondary Outcomes (2)

• Change in inflammatory biomarkers

  Change from baseline inflammatory biomarkers at 6 months

• Change in insulin resistance markers

  Change from baseline insulin resistance markers at 6 months

Study Arms (1)

Weight Loss & Exercise

EXPERIMENTAL

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

Behavioral: Weight Loss and Exercise

Interventions

Weight Loss and Exercise BEHAVIORAL

Internet delivered, behaviorally based weight loss and exercise intervention

Weight Loss & Exercise

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• Dartmouth-Hitchcock Medical Center: collaborator
• University of Massachusetts, Worcester: collaborator

Study Sites (3)

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Dartmouth Hitchcock Medical Center

Hannover, New Hampshire, 03755, United States

Location

Unviersity of Vermont/Fletcher Allen Health Care

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Weight Loss; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kim L Dittus, MD PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: November 19, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

US (3)