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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12 month exercise and weight loss intervention
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, exercise, weight loss, executive function, breast cancer survivor

Eligibility Criteria

21 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vermont Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise and weight loss

Arm Description

12 month exercise and weight loss intervention

Outcomes

Primary Outcome Measures

Correlation of executive function and weight loss success
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
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
Determine the effectiveness of a behavioral weight loss and exercise intervention

Full Information

First Posted
January 30, 2014
Last Updated
December 2, 2014
Sponsor
University of Vermont
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT02052115
Brief Title
Behavioral Weight Loss and Exercise After Treatment (BEAT)
Acronym
BEAT
Official Title
Behavioral Weight Loss and Exercise After Treatment (BEAT): Predictors of Weight Loss Success in Overweight Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, exercise, weight loss, executive function, breast cancer survivor

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
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and weight loss
Arm Type
Other
Arm Description
12 month exercise and weight loss intervention
Intervention Type
Behavioral
Intervention Name(s)
12 month exercise and weight loss intervention
Primary Outcome Measure Information:
Title
Correlation of executive function and weight loss success
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Correlation of cancer related symptoms and weight loss
Description
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
Time Frame
12 months
Title
Efficacy of a weight loss intervention
Description
Determine the effectiveness of a behavioral weight loss and exercise intervention
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Dittus, MD, PhD
Phone
802-656-5470
Email
kim.dittus@vtmednet.org
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Wilson, CCRP
Phone
802-656-4101
Email
karen.m.wilson@uvm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Dittus, MD, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Dittus, MD, PhD
Phone
802-656-5470
Email
kim.dittus@vtmednet.org
First Name & Middle Initial & Last Name & Degree
Karen Wilson, MEd, CCRP
Phone
802-656-4101
Email
karen.m.wilson@uvm.edu
First Name & Middle Initial & Last Name & Degree
Kim Dittus, MD, PhD

12. IPD Sharing Statement

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Behavioral Weight Loss and Exercise After Treatment (BEAT)

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