Endometrial Cancer Diet and Exercise
- Conditions
- Early Stage Endometrial Cancer
- Interventions
- Behavioral: Home-based aerobic exercise and nutritional counseling
- Registration Number
- NCT02987881
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
- 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:
-
Android
o Activity monitor is compatible with most Android devices equipped with Bluetooth 4.0 and running Android 4.3 (Jelly Bean) or later.
-
iOS
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adult women with early stage localized endometrial cancer Home-based aerobic exercise and nutritional counseling Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy
- Primary Outcome Measures
Name Time Method Feasibility as measured by adherence to weekly walking sessions 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 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 baseline and 12 weeks change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure baseline and 12 weeks change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak baseline and 12 weeks change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein baseline and 12 weeks change in cardiorespiratory fitness and CVD risk profile as measured by body composition baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method patient experience with exercise and nutrition counseling as measured by telephone questionnaire 16 weeks
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States