Behavioral Weight Loss and Exercise After Treatment (BEAT)
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 69 |
| Updated: | 4/2/2016 |
| Start Date: | January 2014 |
| End Date: | December 2016 |
| Contact: | Kim Dittus, MD, PhD |
| Email: | kim.dittus@vtmednet.org |
| Phone: | 802-656-5470 |
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.
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.
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
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