Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Feasibility as measured by adherence to weekly walking sessions
研究概览
简要总结
This study will evaluate whether the use of the Jawbone wristband monitor, in connection with home-based exercise and nutritional counseling can be safely completed and improve cardiorespiratory fitness (heart and lung health) in women with early stage endometrial cancer who have undergone surgery.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ages > 18 years.
- •Localized endometrial cancer (stage I and II); no evidence of stage III or IV disease.
- •At least 2 months was passed since the hysterectomy and enrollment.
- •Karnofsky performance status > 70%.
- •Body mass index of 30.0 - 49.9 and body weight < 300 pounds.
- •No plan for adjuvant endometrial cancer therapy.
- •Able to exercise safely on a treadmill.
- •No absolute contraindications to exercise testing as recommended by the American Thoracic Society. No recent (<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
- •The subject is not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting.
- •Able to provide informed consent.
- •Have reliable transportation to the testing facilities.
- •Subjects must be able to speak and understand English to participate in this study.
- •Subjects must have a personal mobile device compatible for the activity monitor
- •Compatible devices for the activity monitors are below:
- •o Activity monitor is compatible with most Android devices equipped with Bluetooth 4.0 and running Android 4.3 (Jelly Bean) or later.
- •iPhone 4s (or newer)
- •iPod touch (5th generation or newer)
- •iPad (3rd generation or newer)
- •iPad mini (1st generation or newer)
- •iPad Air (1st generation or newer)
排除标准
- 未提供
研究组 & 干预措施
Adult women with early stage localized endometrial cancer
Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy
干预措施: Home-based aerobic exercise and nutritional counseling (Behavioral)
结局指标
主要结局
Feasibility as measured by adherence to weekly walking sessions
时间窗: Week 12
Percentage of daily steps divided by total number of steps and daily walking sessions divided by total number of sessions prescribed
Safety as measured by the type and prevalence of adverse events during study-related assessments
时间窗: Week 12
Collection of events related to cardiopulmonary testing and self-reported events during off-site exercise training
change in cardiorespiratory fitness and CVD risk profile as measured by lipid profile
时间窗: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure
时间窗: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak
时间窗: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein
时间窗: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by body composition
时间窗: baseline and 12 weeks
次要结局
- patient experience with exercise and nutrition counseling as measured by telephone questionnaire(16 weeks)