Behavioral Weight Loss and Exercise After Treatment (BEAT) (BEAT)

December 2, 2014 updated by: Kim Dittus, University of Vermont

Behavioral Weight Loss and Exercise After Treatment (BEAT): Predictors of Weight Loss Success in Overweight Breast Cancer Survivors

Overweight and physically inactive breast cancer survivors are at increased risk of breast cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight loss and exercise success include the long term effects such as fatigue, psychological distress and impaired executive (cognitive) function.

This study will explore the variability in how breast cancer survivors respond to a behavioral weight loss intervention. The primary objectives include determining the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function as measured with task performance at 6 and 12 months and associated brain function imaging (fMRI), collected at baseline only.Additionally, the study is designed to determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months following entry into a behavioral weight loss and exercise intervention.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • Vermont Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kim Dittus, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Breast cancer diagnosis
  • Received surgery +/- chemotherapy +/- radiation for treatment of a Stage I, II or III breast cancer. Ongoing treatment with monoclonal antibodies and/or anti-estrogen therapy is acceptable
  • Completion of initial therapy 6 weeks prior to study initiation
  • BMI of 27-45 kg/m^2

Exclusion Criteria:

  • Prior diagnosis of malignancy other than non-melanoma skin cancer (i.e. prior non-melanoma skin cancer is not an exclusion criteria)
  • Medical conditions that limit food choices such as celiac sprue or inflammatory bowel disease
  • Inability to walk on flat ground (or a treadmill) at 2.5 mph for 5 minutes
  • Age <21 and >70
  • Presence of body metal
  • Psychotic or central nervous system impairment that would limit compliance with study requirements, including dementia
  • Evidence of metastatic disease
  • Symptomatic heart disease (chest pain or equivalent with activity)
  • Exercise limiting pulmonary disease or need for oxygen to exercise
  • Individuals taking mood stabilizing medications including: Lithium, valproic acid, also called divalproex sodium (Depakote), carbamazepine (Tegretol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), ziprasidone (Geodon), clozapine (clorazil)
  • Participants with an active neurologic disorder that affects the central nervous system, including seizures, and Parkinson's disease
  • Weight loss of >10 lbs in the previous 6 months
  • Participation in > 150 minutes of moderate intensity activity by self report, unless activity level by accelerometer is less than 150 minutes of moderate intensity activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Exercise and weight loss
12 month exercise and weight loss intervention
Behavioral: 12 month exercise and weight loss intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of executive function and weight loss success
Time Frame: 12 months
Determine the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function, measured with task performance and associated brain function imaging (fMRI), at 6 and 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of cancer related symptoms and weight loss
Time Frame: 12 months
Determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months
12 months
Efficacy of a weight loss intervention
Time Frame: 12 months
Determine the effectiveness of a behavioral weight loss and exercise intervention
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Kim Dittus, MD, PhD, University of Vermont

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCC 1311
  • 1P20GM103644-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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