Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Lifestyle counseling 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
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.
Other: counseling 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.
Other: educational 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.
Other: preventative 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.
Procedure: quality-of-life assessment
Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
|
| Active Comparator: Without Counseling Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months. |
Procedure: quality-of-life assessment
Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed endometrial cancer meeting the following criteria:
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Stage I or II disease
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Post-operative total abdominal hysterectomy and bilateral salpingo-oophorectomy
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Disease in remission
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44106-5047 |
Sponsors and Collaborators
- Case Comprehensive Cancer Center
Investigators
- Principal Investigator: Vivian von Gruenigen, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CASE5804
- NCT00420979