Overview

This trial is active, not recruiting.

Conditions cancer survivor, 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
Treatments exercise intervention, quality-of-life assessment, questionnaire administration
Sponsor Albert Einstein College of Medicine of Yeshiva University
Collaborator National Cancer Institute (NCI)
Start date October 2013
End date January 2016
Trial size 30 participants
Trial identifier NCT02575872, 000347, 2013-2167, NCI-2014-01510, P30CA013330

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
Arm
(Experimental)
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.
exercise intervention
Participate in physical activity behavioral intervention
quality-of-life assessment Quality of Life Assessment
Ancillary studies
questionnaire administration
Ancillary studies
(No 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 Outcomes

Measure
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

Secondary Outcomes

Measure
Barrier avoidance/coping, measured using 5 point Likert scales
time frame: Up to 12 weeks
BMI
time frame: Up to 12 weeks
Change in ability to perform activities of daily living, assessed with the YPAS
time frame: Baseline to 12 weeks
Change in sedentary time, assessed with the YPAS
time frame: Baseline to 12 weeks
Exercise efficacy, measured using 5 point Likert scales
time frame: Up to 12 weeks
Fatigue, assessed by the FACT-Fatigue
time frame: Up to 12 weeks
Outcome expectations, measured using 5 point Likert scales
time frame: Up to 12 weeks
Physical function score
time frame: Up to 12 weeks
Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer
time frame: Up to 12 weeks
Self-regulation, measured using 5 point Likert scales
time frame: Up to 12 weeks
Social support, measured using 5 point Likert scales
time frame: Up to 12 weeks
Waist circumference
time frame: Up to 12 weeks

Eligibility Criteria

Female participants from 18 years up to 90 years old.

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

Additional Information

Official title The Effectiveness of a Comprehensive Physical Activity Behavioral Intervention on Underserved Diverse Obese Endometrial Cancer Survivors
Principal investigator Nicole Nevadunsky
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Albert Einstein College of Medicine of Yeshiva University.
Location data was received from the National Cancer Institute and was last updated in April 2016.