Endometrial Cancer, Weight Changes
Conditions
Keywords
stage I endometrial carcinoma, stage II endometrial carcinoma, weight changes
Brief 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.
Interventions
BEHAVIORALbehavioral 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.
OTHERcounseling 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.
OTHEReducational 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.
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.
PROCEDUREquality-of-life assessment
Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed endometrial cancer meeting the following criteria: * Stage I or II disease * Post-operative total abdominal hysterectomy and bilateral salpingo-oophorectomy * Disease in remission * Body Mass Index (BMI) ≥ 25 PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Not specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months | baseline, 3, 6, and 12 months |
| Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) | baseline, 3, 6, and 12 months |
| Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months | baseline, 3, 6, and 12 months |
Countries
United States
Outcome results
None listed