Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in weight
研究概览
简要总结
This study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of Hispanic or African descent (n=45). This is a randomized, crossover pilot and feasibility study to test the effects of a 30-minute circuit-based exercise program that combines resistance training with aerobic exercise in conjunction with a low-fat calorie reduced diet. Participants will be randomized to either an immediate 6-months of exercise and dietary change, or a delayed group who will begin their exercise and dietary change program 6-months after the study begins. Participants in the immediate group will be followed for an additional 6-months in order to evaluate adherence to the exercise and dietary change recommendations. Participants in both groups will exercise at a neighborhood Curves® facility at least 5 times per week for six months and will participate in a series of nutrition education classes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •21-70 yrs
- •Stage 0-IIIa breast cancer
- •No evidence of recurrent/metastatic disease
- •Hispanic or African descent (African-American or Caribbean)
- •BMI > 25kg/m2
- •Sedentary
- •Completed surgery, chemotherapy, and radiation therapy ≥ 6 months
- •Blood pressure < 140/90
- •HgbA1C < 8
- •LDL cholesterol < 150
- •No uncontrolled comorbidities
- •VO2 max normal EKG changes
- •Non-smoker
排除标准
- •Evidence of recurrent or metastatic breast cancer
- •Uncontrolled co-morbid illness including, but not limited to, type I diabetes mellitus, type II diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements
- •Currently taking Herceptin therapy, or abnormal echo or MUGA post-Herceptin therapy
- •Active tobacco use
- •Currently active in an exercise and/or dietary change weight loss program
- •If a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.
结局指标
主要结局
Change in weight
时间窗: 6 months, 12 months
Intervention adherence
时间窗: 6 months, 12 months
次要结局
- Barriers to participation(3 months, 6 months, 9 months, 12 months)
- Predictors of adherence(3 months, 6 months, 9 months, 12 months)
- Changes in anthropometric measures(3 months, 6 months, 9 months, 12 months)
- Changes in fitness(3 months, 6 months, 9 months, 12 months)
- Changes in hormonal biomarkers(3 months, 6 months, 9 months, 12 months)
- Changes in metabolic markers(3 months, 6 months, 9 months, 12 months)
- Changes in psychological and quality of life measures(3 months, 6 months, 9 months, 12 months)
研究者
Heather Greenlee
Assistant Professor, Department of Epidemiology
Columbia University