Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effectiveness of a Comprehensive Physical Activity Behavioral Intervention on Underserved Diverse Obese Endometrial Cancer Survivors

Conditions
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Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer, Stage II Uterine Corpus Cancer, Stage IIIA Uterine Corpus Cancer, Stage IIIB Uterine Corpus Cancer, Stage IIIC Uterine Corpus Cancer, Stage IVA Uterine Corpus Cancer, Stage IVB Uterine Corpus Cancer

Intervention / Treatment
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* Behavioral: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent form signed and dated by the subject English and/or Spanish speaking History of endometrial cancer stage I-IV > 6 months < 5 years, not currently receiving cancer treatment Overweight (body mass index [BMI] >= 30) Eastern Cooperative Oncology Group performance status (PS) of 0 - 2 Medically capable of performing moderate intensity exercise Exclusion Criteria: Must not have engaged in a regular (> 3x/week, physical activity program in the last 6 months) Medical contraindication to exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>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. | Behavioral: Exercise Intervention<br>* Participate in physical activity behavioral intervention<br>|
| No Intervention: wait-list for intervention<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |