Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer, Stage IIIA Uterine Corpus Cancer, Stage IIIB Uterine Corpus Cancer, Stage IIIC Uterine Corpus Cancer, Stage II Uterine Corpus Cancer, Stage IVA Uterine Corpus Cancer, Stage IVB Uterine Corpus Cancer
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALExercise Intervention
Participate in physical activity behavioral intervention
Sponsors
National Cancer Institute (NCI)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS) | 12 weeks | Data will be analyzed using Pearson Chi-square test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | Up to 12 weeks | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. |
| Change in ability to perform activities of daily living, assessed with the YPAS | Baseline to 12 weeks | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. |
| Change in sedentary time, assessed with the YPAS | Baseline to 12 weeks | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. |
| Exercise efficacy, measured using 5 point Likert scales | Up to 12 weeks | 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. |
| Fatigue, assessed by the FACT-Fatigue | Up to 12 weeks | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. |
| Barrier avoidance/coping, measured using 5 point Likert scales | Up to 12 weeks | 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. |
| Physical function score | Up to 12 weeks | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. |
| Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer | Up to 12 weeks | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. |
| Self-regulation, measured using 5 point Likert scales | Up to 12 weeks | 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. |
| Social support, measured using 5 point Likert scales | Up to 12 weeks | 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. |
| Waist circumference | Up to 12 weeks | Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests. |
| Outcome expectations, measured using 5 point Likert scales | Up to 12 weeks | 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. |
Countries
United States
Outcome results
None listed