Trial Information

Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors

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.