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| Name | Class |
|---|---|
| Duke Cancer Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult women with early stage localized endometrial cancer | Experimental | Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based aerobic exercise and nutritional counseling | Behavioral | Moderate walking and running with nutritional counseling at study visits. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| patient experience with exercise and nutrition counseling as measured by telephone questionnaire | 16 weeks |
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Inclusion Criteria:
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
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Angeles A Secord, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34178654 | Result | 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. |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Open Label
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |