Brief Title
Endometrial Cancer Diet and Exercise
Official Title
Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors
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.
Study Type
Interventional
Primary Outcome
Feasibility as measured by adherence to weekly walking sessions
Secondary Outcome
patient experience with exercise and nutrition counseling as measured by telephone questionnaire
Condition
Early Stage Endometrial Cancer
Intervention
Home-based aerobic exercise and nutritional counseling
Study Arms / Comparison Groups
Adult women with early stage localized endometrial cancer
Description: Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
16
Start Date
February 1, 2017
Completion Date
June 1, 2019
Primary Completion Date
June 1, 2019
Eligibility Criteria
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:
-
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Angeles A Secord, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02987881
Organization ID
Pro00074542
Responsible Party
Sponsor
Study Sponsor
Duke University
Collaborators
Duke Cancer Institute
Study Sponsor
Angeles A Secord, M.D., Principal Investigator, Duke University
Verification Date
June 2019