Endometrial Cancer Clinical Trial
Official title:
Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors
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.
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.
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