Behavioral Weight Loss and Exercise After Treatment (BEAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Vermont
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kim Dittus, University of Vermont
ClinicalTrials.gov Identifier:
NCT02052115
First received: January 30, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: 12 month exercise and weight loss intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Behavioral Weight Loss and Exercise After Treatment (BEAT): Predictors of Weight Loss Success in Overweight Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Correlation of executive function and weight loss success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Correlation of cancer related symptoms and weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

  • Efficacy of a weight loss intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determine the effectiveness of a behavioral weight loss and exercise intervention


Estimated Enrollment: 80
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Exercise and weight loss
12 month exercise and weight loss intervention
Behavioral: 12 month exercise and weight loss intervention

  Eligibility

Ages Eligible for Study:   21 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 6-36 months 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052115

Contacts
Contact: Kim Dittus, MD, PhD 802-656-5470 kim.dittus@vtmednet.org
Contact: Karen Wilson, CCRP 802-656-4101 karen.m.wilson@uvm.edu

Locations
United States, Vermont
Vermont Cancer Center Recruiting
Burlington, Vermont, United States, 05405
Contact: Kim Dittus, MD, PhD    802-656-5470    kim.dittus@vtmednet.org   
Contact: Karen Wilson, MEd, CCRP    802-656-4101    karen.m.wilson@uvm.edu   
Principal Investigator: Kim Dittus, MD, PhD         
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Kim Dittus, MD, PhD University of Vermont
  More Information

No publications provided

Responsible Party: Kim Dittus, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT02052115     History of Changes
Other Study ID Numbers: VCC 1311, 1P20GM103644-01A1
Study First Received: January 30, 2014
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
breast cancer
exercise
weight loss
executive function
breast cancer survivor

Additional relevant MeSH terms:
Breast Neoplasms
Weight Loss
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014