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Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

Primary Purpose

Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer, Stage II Uterine Corpus Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage IA Uterine Corpus Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Intervention

wait-list for intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
BMI
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
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
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
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
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
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
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
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
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
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
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.

Full Information

First Posted
October 13, 2015
Last Updated
September 13, 2019
Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02575872
Brief Title
Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors
Official Title
The Effectiveness of a Comprehensive Physical Activity Behavioral Intervention on Underserved Diverse Obese Endometrial Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
wait-list for intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Participate in physical activity behavioral intervention
Primary Outcome Measure Information:
Title
Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS)
Description
Data will be analyzed using Pearson Chi-square test.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Barrier avoidance/coping, measured using 5 point Likert scales
Description
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
Title
BMI
Description
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
Title
Change in ability to perform activities of daily living, assessed with the YPAS
Description
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
Title
Change in sedentary time, assessed with the YPAS
Description
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
Title
Exercise efficacy, measured using 5 point Likert scales
Description
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
Title
Fatigue, assessed by the FACT-Fatigue
Description
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
Title
Outcome expectations, measured using 5 point Likert scales
Description
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
Title
Physical function score
Description
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
Title
Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer
Description
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
Title
Self-regulation, measured using 5 point Likert scales
Description
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
Title
Social support, measured using 5 point Likert scales
Description
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
Title
Waist circumference
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Nevadunsky
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

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