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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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This early phase I clinical trial measures the changes in functional fitness following home-based comprehensive exercise program in patients who have endometrial cancer who have completed treatment. Endometrial cancer is an increasingly common diagnosis, with health and quality of life concerns persisting after the active cancer treatment period. Exercise in cancer survivors has the potential to reduce the risk of death by improving cardiovascular fitness, quality of life, strength, longevity, and independence. A home-based exercise programs may be a feasible approach for exercise programming in patients who have endometrial cancer who have completed treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional fitness following home-based comprehensive exercise program | Other | Patients complete a home-based exercise program, receive remote health coaching sessions, and complete functional fitness tests on study. Patients also wear a Fitbit and receive health education on study. |
| Measure | Description | Time Frame |
|---|---|---|
| Chair sit to stand test | Will be assessed using the Functional Fitness Test, which is a battery of six tests including the 30 second chair stand, the 30 second arm curl, the 6-minute walk, the chair sit and reach, the 8-foot up and go, and the back scratch tests. Mixed effects regression models will be used to estimate changes in each of the 6 tests included in the Functional Fitness Test from pre- to post-intervention. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean changes and associated 90% confidence intervals will be reported. Primary outcome is number of repetitions in the chair sit to stand test | baseline, pre-intervention and immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Will be summarized by system organ class and/or preferred term, type of adverse event, severity (based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, [NCI CTCAE v 5.0] grades), and relation to study treatment. The most severe grade per patient will be reported. | Up to 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Gorzelitz, PhD | University of Iowa Holden Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 55242 | United States |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Muscle strengthening exercise session adherence | Exercise session adherence will be defined as the proportion of planned exercise sessions in which a participant completes at least 50% of the prescribed exercises. The mean and associated 90% confidence interval will be reported | Up to 10 weeks |
| Aerobic physical activity adherence | Aerobic physical activity adherence will be defined as the proportion of planned weeks a participant accumulates 150 minutes of moderate intensity activity. The mean and associated 90% confidence interval will be reported. | Up to 10 weeks |
| Tele coaching adherence | Tele coaching adherence will be defined as the proportion of planned exercise sessions in which a participant completes. The mean and associated 90% confidence interval will be reported. | Up to 10 weeks |
| Exercise program acceptability | Acceptability will be assessed using Likert scale ratings of quality of exercise equipment, educational materials, health coaching, study feedback and distance-delivery format. Means and associated 90% confidence intervals will be reported for each item. | Up to 10 weeks |
| Body weight | Will be assessed by the within patient change of weight, waist and hip circumferences will be assessed from pre- to post-intervention. Mixed effects regression models will be used to estimate changes in anthropometrics. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean changes and associated 90% confidence intervals will be reported. Primary secondary outcome is changes in weight. | baseline, pre-intervention and immediately after the intervention |
| Ambulatory activity levels | Will be assessed by the within patient change in average daily steps taken within a week will be assessed from pre- to post-intervention. Mixed effects regression models will be used to estimate changes in ambulatory activity levels. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean and associated 90% confidence interval will be reported. | baseline, pre-intervention and immediately after the intervention |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |