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

Endometrial Cancer Clinical Trial

Official title:

Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262938
• Other study ID #: CASE5804
• Status: Completed
• Phase: N/A
• Start date: February 2005
• Est. completion date: August 2011

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00420979

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2011
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight Changes
• Endometrial Cancer
• Endometrial Neoplasms
• Weight Changes

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36)		baseline, 3, 6, and 12 months
Primary	Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months		baseline, 3, 6, and 12 months