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.
Brief Title
Physical Activity Behavioral Intervention in 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.
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.
Completion Date
Completion Date Type
Actual
Conditions
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
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
* 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
Inclusion 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
* 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
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
90 Years
Minimum Age
18 Years
NCT Id
NCT02575872
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2013-2167
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The Effectiveness of a Comprehensive Physical Activity Behavioral Intervention on Underserved Diverse Obese Endometrial Cancer Survivors
Primary Outcomes
Outcome Description
Data will be analyzed using Pearson Chi-square test.
Outcome Measure
Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS)
Outcome Time Frame
12 weeks
Secondary Ids
Secondary Id
NCI-2014-01510
Secondary Id
2013-2167
Secondary Id
P30CA013330
Secondary Outcomes
Outcome 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.
Outcome Time Frame
Up to 12 weeks
Outcome Measure
Barrier avoidance/coping, measured using 5 point Likert scales
Outcome Description
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Outcome Time Frame
Up to 12 weeks
Outcome Measure
BMI
Outcome Description
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Outcome Time Frame
Baseline to 12 weeks
Outcome Measure
Change in ability to perform activities of daily living, assessed with the YPAS
Outcome Description
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Outcome Time Frame
Baseline to 12 weeks
Outcome Measure
Change in sedentary time, assessed with the YPAS
Outcome 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.
Outcome Time Frame
Up to 12 weeks
Outcome Measure
Exercise efficacy, measured using 5 point Likert scales
Outcome Description
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Outcome Time Frame
Up to 12 weeks
Outcome Measure
Fatigue, assessed by the FACT-Fatigue
Outcome 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.
Outcome Time Frame
Up to 12 weeks
Outcome Measure
Outcome expectations, measured using 5 point Likert scales
Outcome Description
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Outcome Time Frame
Up to 12 weeks
Outcome Measure
Physical function score
Outcome Description
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Outcome Time Frame
Up to 12 weeks
Outcome Measure
Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer
Outcome 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.
Outcome Time Frame
Up to 12 weeks
Outcome Measure
Self-regulation, measured using 5 point Likert scales
Outcome 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.
Outcome Time Frame
Up to 12 weeks
Outcome Measure
Social support, measured using 5 point Likert scales
Outcome Description
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Outcome Time Frame
Up to 12 weeks
Outcome Measure
Waist circumference
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
90
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nicole Nevadunsky
Investigator Email
nnevadun@montefiore.org
Investigator Phone
718-405-8082