A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Lifestyle intervention
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Lifestyle intervention
时间窗: 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.
次要结局
- Lipid Profiles, hemoglobin A1C(1 year)
研究者
Michelle Gallas
Clinical Research Administrator
Baptist Health South Florida