Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

Albert Einstein College of Medicine

Status: Completed

Conditions: Stage IIIB Uterine Corpus Cancer; Stage IIIA Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IIIC Uterine Corpus Cancer; Stage IA Uterine Corpus Cancer; Stage IB Uterine Corpus Cancer

Treatments: Behavioral: Exercise Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02575872

P30CA013330 (U.S. NIH Grant/Contract)

NCI-2014-01510 (Registry Identifier)

2013-2167 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Exercise Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Intervention

wait-list for intervention

No Intervention group

Description:

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.