Endometrial Cancer Diet and Exercise

Study Overview
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Brief Summary
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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.

Official Title
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Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors

Conditions
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Early Stage Endometrial Cancer

Intervention / Treatment
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* Behavioral: Home-based aerobic exercise and nutritional counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult women with early stage localized endometrial cancer<br>Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy | Behavioral: Home-based aerobic exercise and nutritional counseling<br>* Moderate walking and running with nutritional counseling at study visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by adherence to weekly walking sessions | Percentage of daily steps divided by total number of steps and daily walking sessions divided by total number of sessions prescribed | Week 12 | 
| Safety as measured by the type and prevalence of adverse events during study-related assessments | Collection of events related to cardiopulmonary testing and self-reported events during off-site exercise training | Week 12 | 
| 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 blood pressure |  | baseline and 12 weeks | 
| 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 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient experience with exercise and nutrition counseling as measured by telephone questionnaire |  | 16 weeks |