Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

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

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.

Study Overview

• Status: Completed
• Conditions: Stage II Uterine Corpus Cancer; 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 IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer
• Intervention / Treatment: Behavioral: Exercise Intervention

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Exercise Intervention; Participate in physical activity behavioral intervention
No Intervention: wait-list for 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: 2013-2167 (Other Identifier: Albert Einstein College of Medicine); P30CA013330 (U.S. NIH Grant/Contract); NCI-2014-01510 (Registry Identifier: CTRP (Clinical Trial Reporting Program))