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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
30
Participate in physical activity behavioral intervention
Albert Einstein College of Medicine
The Bronx, New York, United States
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.
Time frame: 12 weeks
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.
Time frame: Up to 12 weeks
BMI
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 weeks
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