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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
First received
Last updated
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
Health authority
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

Study Design


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
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