Breast Cancer
Conditions
Keywords
breast cancer, exercise, weight loss, executive function, breast cancer survivor
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.
Interventions
BEHAVIORAL12 month exercise and weight loss intervention
Sponsors
National Institute of General Medical Sciences (NIGMS)
University of Vermont
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of executive function and weight loss success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of cancer related symptoms and weight loss | 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 |
| Efficacy of a weight loss intervention | 12 months | Determine the effectiveness of a behavioral weight loss and exercise intervention |
Countries
United States
Contacts
Primary ContactKim Dittus, MD, PhD
Backup ContactKaren Wilson, CCRP
Outcome results
None listed