NCT00262938

Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission

Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably. PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage I or stage II endometrial cancer in remission.

Detailed description

OBJECTIVES: Primary * Determine the combined effect of exercise and dietary counseling on the weight loss and quality of life of obese patients with stage I or II endometrial cancer in remission. Secondary * Determine the feasibility and acceptability of lifestyle interventions in these patients. OUTLINE: This is a randomized, controlled study. Patients are stratified according to age and body mass index (25-29.9 vs ≥ 30). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months. * Arm II: Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months. After completion of study treatment, patients are followed at 1 year. PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

Conditions

• Endometrial Cancer
• Weight Changes

Interventions

Type	Name	Description
BEHAVIORAL	behavioral dietary intervention	Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
OTHER	counseling intervention	Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
OTHER	educational intervention	Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
OTHER	preventative dietary intervention	Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
PROCEDURE	quality-of-life assessment	Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.

Timeline

• Start date: 2005-02-01
• Primary completion: 2006-01-01
• Completion: 2011-08-01
• First posted: 2005-12-07
• Last updated: 2020-07-24

Locations

1 site across 1 country: United States