Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission
Condition: Endometrial Cancer; Weight Changes
MeSH terms: Endometrial Neoplasms; Body Weight Changes
Study type: Interventional

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.
    

Intervention name(s): behavioral dietary intervention; counseling intervention; educational intervention; preventative dietary intervention; quality-of-life assessment
Intervention type(s): Behavioral; Other; Other; Other; Procedure
Intervention description(s): 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.; 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.; 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.; 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.; Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: stage I endometrial carcinoma; stage II endometrial carcinoma; weight changes