Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

Stage II Uterine Corpus Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575872
• Other study ID #: 2013-2167
• Secondary ID: NCI-2014-0151020
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: June 2018

Study information

• Verified date: September 2019
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• 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
• Uterine Neoplasms

Intervention

Behavioral:
• Exercise Intervention
Participate in physical activity behavioral intervention

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	BMI	Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.	Up to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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