Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2017-02-01
2019-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Adult women with early stage localized endometrial cancer
Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy
Home-based aerobic exercise and nutritional counseling
Moderate walking and running with nutritional counseling at study visits.
Interventions
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Home-based aerobic exercise and nutritional counseling
Moderate walking and running with nutritional counseling at study visits.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Duke Cancer Institute
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Angeles A Secord, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Schwartz AR, Bartlett DB, Johnson JL, Broadwater G, Channell M, Nolte KC, Wilkes PA, Huffman KM, Secord AA. A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors. Front Oncol. 2021 Jun 11;11:669961. doi: 10.3389/fonc.2021.669961. eCollection 2021.
Other Identifiers
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Pro00074542
Identifier Type: -
Identifier Source: org_study_id
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