A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer

N/ACompletedNCT02037542

Baptist Health South Florida100 enrolled

Overview

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.

* 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Weight

Interventions

Diet and exerciseBEHAVIORAL

Upon enrollment, the patient will be asked to meet with a dietitian to assess the individual patient's current diet and exercise routines. In the first session, the dietitian will provide individual counseling and together with the patient devise weight loss / exercise strategies that fit the patients' lifestyle. Following the initial assessment, patients will embark on a weekly program, with weekly meetings lasting 30min - 1h. Patients will be asked to record meal portions weekly in a Food Log (Appendix B), according to the established goal. At each meeting, the dietitian will review the Food Log with the patient and evaluate progress.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * DCIS * 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.

Locations (1)

South Miami Hospital

Miami, Florida, United States

Outcomes

Primary Outcomes

Lifestyle intervention

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.

Time frame: One year

Secondary Outcomes

Lipid Profiles, hemoglobin A1C

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 and 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.

Time frame: 1 year

Data from ClinicalTrials.gov

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