A Cardiac Rehabilitation Program for Breast Cancer Survivors: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasibility of conducting a 14-week CR program
研究概览
简要总结
This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause of death of women in both the general population and the breast cancer survivor population. There are many risk factors common to both heart disease and breast cancer development, including physical inactivity. A cardiac rehabilitation program may help improve cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of life among breast cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. Assess the feasibility of conducting a 14-week cardiac rehabilitation (CR) program in women with breast cancer after completion of acute therapy.
II. Preliminarily evaluate the efficacy of CR in improving cardiorespiratory fitness (peak oxygen uptake, maximum volume of oxygen [VO2 max]) at baseline and 14 weeks.
III. Explore changes in cardiovascular disease (CVD) risk factors (blood pressure, cholesterol, fasting glucose, and body mass index) between baseline and 14-week follow-up. Blood pressure and body mass index will also be checked at 8 weeks.
IV. Quantify the difference in quality of life (QoL) between baseline, 8 week, and 14 week follow up, adjusting for baseline QoL values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with breast cancer stages 0-III within 6 months after completion of all planned surgery, radiation and or chemotherapy treatments
- •Concurrent endocrine therapy permissible
- •Ability to understand and the willingness to sign a written informed consent
- •Willingness to participate in CR program
排除标准
- •Existing CVD
- •Existing diabetes
- •Contraindications to exercise
- •Metastatic breast cancer
- •Other concurrent malignancies except skin cancer
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situation that would limit compliance with study requirements
- •Pregnant or nursing women
- •Unable to give informed consent
- •Any contraindication to cardiac stress testing
- •Travel distance greater than 50 miles
结局指标
主要结局
Feasibility of conducting a 14-week CR program
时间窗: 14 weeks
During the course of the 14-week intervention period, the CR medical director will monitor CR staff adherence to the study protocol. Every 2 weeks, they will review intervention participants' baseline graded exercise test results and subsequent exercise prescriptions to ensure the intervention is targeted at the appropriate level of each participant's VO2 max. Will administer a satisfaction questionnaire to intervention participants. Results from these surveys will be evaluated during the course of the study by the principal investigator and used to improve the study process as appropriate.
次要结局
- Efficacy of CR in improving cardiorespiratory fitness(At 14 weeks)