A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Weight
- Sponsor
- Baptist Health South Florida
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Lifestyle intervention
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to test the hypothesis that an intervention of lifestyle modification will positively impact women with breast cancer who are overweight and/or obese. To that end, our primary endpoint is to examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.
Detailed Description
* Primary endpoint: To examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study. * Secondary endpoint: To assess the impact of such intervention on lipid profiles and hemoglobin A1C. The study group will be compared with a historical control group of patients with early stage breast cancer who are obese or overweight who were not given the intervention * Secondary endpoint: To examine whether an active intervention program will lead into longstanding lifestyle modification in breast cancer patients with a BMI greater or equal to 25.
Investigators
Michelle Gallas
Clinical Research Administrator
Baptist Health South Florida
Eligibility Criteria
Inclusion Criteria
- •Women with stage 0 - III breast cancer (histologic type ductal or lobular)
- •BMI \>=25
- •Patients must have completed all chemotherapy
- •Patients may be on hormonal therapy or radiation therapy
- •Age \>= 18 years old to 89 Years old
- •Patient must be medically stable and without significant impairments that would preclude following the proposed intervention regimen.
- •Time of diagnosis: patients enrolled are within 1 month to 18 months post-diagnosis.
Exclusion Criteria
- •Metastatic breast cancer patients and patients with inoperable or active loco-regional disease.
- •Patients following alternative/complementary diets or taking high dose antioxidant supplements.
- •Patients with a physical/psychiatric impairment that would seriously impair their physical mobility.
- •Patients who are currently suffering from severe nausea, anorexia or other diseases affecting health (e.g. arthritis and multiple sclerosis).
- •Patients younger than 18 and older than 89 years.
Outcomes
Primary Outcomes
Lifestyle intervention
Time Frame: One year
To examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.
Secondary Outcomes
- Lipid Profiles, hemoglobin A1C(1 year)