Behavioral Weight Loss and Exercise After Treatment (BEAT)

University of Vermont

Status

Unknown

Conditions

Breast Cancer

Treatments

Behavioral: 12 month exercise and weight loss intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02052115

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

VCC 1311

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

21 to 69 years old

Volunteers

No 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