Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors
- 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.
- Determine the feasibility and acceptability of lifestyle interventions in these
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months
baseline, 3, 6, and 12 months
Vivian von Gruenigen, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|