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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01510 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2013-2167 | Other Identifier | Albert Einstein College of Medicine | |
| P30CA013330 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized clinical trial studies a physical activity behavioral intervention in obese endometrial cancer survivors. Learning about physical activity behavior while participating in a fitness class may help increase physical activity and improve the quality of life of obese endometrial cancer survivors.
PRIMARY OBJECTIVES:
I. To determine the effect of a 12-week behavior/exercise intervention on moderate-vigorous physical activity (> 150 minutes) among ethnically diverse endometrial cancer survivors.
SECONDARY OBJECTIVES:
I. To determine the effects of a 12-week behavior/exercise intervention on body composition among ethnically diverse endometrial cancer survivors.
TERTIARY OBJECTIVES:
I. To determine the effects of a 12-week behavior/exercise intervention for ethnically diverse endometrial cancer survivors on physical function and quality-of-life.
II. To determine the most important behavioral variables for predicting physical activity adherence.
III. To determine the most significant facilitators and barriers to adherence during the 12-week intervention.
IV. To compare the thematic differences between high-adherence and low-adherence participants and qualitatively assess the strengths and weaknesses of the 12-week intervention.
OUTLINE: Participants are randomized to 1 of 2 groups
GROUP I: Participants partake in 30 minutes of group discussions regarding physical activity behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of class for 12 weeks.
GROUP II: Participants receive a handout indicating the importance of physical activity and improved nutrition for health outcomes. After 12 weeks, patients are invited to participate in the physical behavior intervention as in Group I.
After completion of study, participants are followed up at 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental | Participants partake in 30 minutes of group discussions regarding physical activity behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of class for 12 weeks. |
|
| wait-list for intervention | No Intervention | Participants receive a handout indicating the importance of physical activity and improved nutrition for health outcomes. After 12 weeks, patients are invited to participate in the physical behavior intervention as in Group I. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Participate in physical activity behavioral intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS) | Data will be analyzed using Pearson Chi-square test. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Barrier avoidance/coping, measured using 5 point Likert scales | Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders. | Up to 12 weeks |
| BMI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Nevadunsky | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36971688 | Derived | Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3. |
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Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. |
| Up to 12 weeks |
| Change in ability to perform activities of daily living, assessed with the YPAS | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. | Baseline to 12 weeks |
| Change in sedentary time, assessed with the YPAS | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. | Baseline to 12 weeks |
| Exercise efficacy, measured using 5 point Likert scales | Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders. | Up to 12 weeks |
| Fatigue, assessed by the FACT-Fatigue | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. | Up to 12 weeks |
| Outcome expectations, measured using 5 point Likert scales | Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders. | Up to 12 weeks |
| Physical function score | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. | Up to 12 weeks |
| Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. | Up to 12 weeks |
| Self-regulation, measured using 5 point Likert scales | Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders. | Up to 12 weeks |
| Social support, measured using 5 point Likert scales | Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders. | Up to 12 weeks |
| Waist circumference | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. | Up to 12 weeks |