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Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02575872
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nicole Nevadunsky, Albert Einstein College of Medicine

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Exercise Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of a Comprehensive Physical Activity Behavioral Intervention on Underserved Diverse Obese Endometrial Cancer Survivors
Actual Study Start Date : October 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS) [ Time Frame: 12 weeks ]
    Data will be analyzed using Pearson Chi-square test.


Secondary Outcome Measures :
  1. Barrier avoidance/coping, measured using 5 point Likert scales [ Time Frame: Up to 12 weeks ]
    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.

  2. BMI [ Time Frame: Up to 12 weeks ]
    Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.

  3. Change in ability to perform activities of daily living, assessed with the YPAS [ Time Frame: Baseline to 12 weeks ]
    Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.

  4. Change in sedentary time, assessed with the YPAS [ Time Frame: Baseline to 12 weeks ]
    Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.

  5. Exercise efficacy, measured using 5 point Likert scales [ Time Frame: Up to 12 weeks ]
    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.

  6. Fatigue, assessed by the FACT-Fatigue [ Time Frame: Up to 12 weeks ]
    Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.

  7. Outcome expectations, measured using 5 point Likert scales [ Time Frame: Up to 12 weeks ]
    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.

  8. Physical function score [ Time Frame: Up to 12 weeks ]
    Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.

  9. Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer [ Time Frame: Up to 12 weeks ]
    Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.

  10. Self-regulation, measured using 5 point Likert scales [ Time Frame: Up to 12 weeks ]
    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.

  11. Social support, measured using 5 point Likert scales [ Time Frame: Up to 12 weeks ]
    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.

  12. Waist circumference [ Time Frame: Up to 12 weeks ]
    Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575872


Locations
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United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nicole Nevadunsky Albert Einstein College of Medicine

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Responsible Party: Nicole Nevadunsky, Principal Investigator, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02575872     History of Changes
Other Study ID Numbers: 2013-2167
NCI-2014-01510 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2013-2167 ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( U.S. NIH Grant/Contract )
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female