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Completed

NCT Number: NCT02575872

Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

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.

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Key information

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

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

Participate in physical activity behavioral intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2015
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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