Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors

Conditions
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Weight Changes, Endometrial Cancer

Intervention / Treatment
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* Behavioral: behavioral dietary intervention
* Other: counseling intervention
* Other: educational intervention
* Other: preventative dietary intervention
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle counseling<br>Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling.Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months. | Behavioral: behavioral dietary intervention<br>* 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.<br>Other: counseling intervention<br>* 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.<br>Other: educational intervention<br>* 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.<br>Other: preventative dietary intervention<br>* 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.<br>Procedure: quality-of-life assessment<br>* Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.<br>|
| Active Comparator: Without Counseling<br>Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months. | Procedure: quality-of-life assessment<br>* Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I endometrial carcinoma, stage II endometrial carcinoma, weight changes