Clinical trial NCT02575872: Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors
Official title: The Effectiveness of a Comprehensive Physical Activity Behavioral Intervention on Underserved Diverse Obese Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-10-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Barrier avoidance/coping, measured using 5 point Likert scales
timeFrame: Up to 12 weeks
measure: BMI
timeFrame: Up to 12 weeks
measure: Change in ability to perform activities of daily living, assessed with the YPAS
timeFrame: Baseline to 12 weeks
measure: Change in sedentary time, assessed with the YPAS
timeFrame: Baseline to 12 weeks
measure: Exercise efficacy, measured using 5 point Likert scales
timeFrame: Up to 12 weeks
measure: Fatigue, assessed by the FACT-Fatigue
timeFrame: Up to 12 weeks
measure: Outcome expectations, measured using 5 point Likert scales
timeFrame: Up to 12 weeks
measure: Physical function score
timeFrame: Up to 12 weeks
measure: Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer
timeFrame: Up to 12 weeks
measure: Self-regulation, measured using 5 point Likert scales
timeFrame: Up to 12 weeks
measure: Social support, measured using 5 point Likert scales
timeFrame: Up to 12 weeks
measure: Waist circumference
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Nicole Nevadunsky
role: PRINCIPAL_INVESTIGATOR
References: