Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

Not Applicable

Completed

• Conditions: Stage IA Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage IIIC Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IB Uterine Corpus Cancer; Stage IIIA Uterine Corpus Cancer; Stage IIIB Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer
• Interventions: Behavioral: Exercise Intervention

• Registration Number: NCT02575872
• Lead Sponsor: Albert Einstein College of Medicine

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Primary Completion: 2018-04
• Study Completion: 2018-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Intervention	Exercise Intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.
BMI	Up 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.
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.
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.

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States