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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.
OBJECTIVES:
Primary
Secondary
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.
After completion of study treatment, patients are followed at 1 year.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle counseling | Active Comparator | 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. |
|
| Without Counseling | Active Comparator | Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral dietary intervention | Behavioral | 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. |
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed endometrial cancer meeting the following criteria:
Body Mass Index (BMI) ≥ 25
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY: Not specified
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| Name | Affiliation | Role |
|---|---|---|
| Vivian von Gruenigen, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5047 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21173649 | Derived | von Gruenigen VE, Waggoner SE, Frasure HE, Kavanagh MB, Janata JW, Rose PG, Courneya KS, Lerner E. Lifestyle challenges in endometrial cancer survivorship. Obstet Gynecol. 2011 Jan;117(1):93-100. doi: 10.1097/AOG.0b013e31820205b3. | |
| 19243603 | Derived | von Gruenigen VE, Gibbons HE, Kavanagh MB, Janata JW, Lerner E, Courneya KS. A randomized trial of a lifestyle intervention in obese endometrial cancer survivors: quality of life outcomes and mediators of behavior change. Health Qual Life Outcomes. 2009 Feb 25;7:17. doi: 10.1186/1477-7525-7-17. |
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|
| counseling intervention | Other | 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. |
|
| educational intervention | Other | 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. |
|
| preventative dietary intervention | Other | 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. |
|
| quality-of-life assessment | Procedure | Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months. |
|
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
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