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

Not Applicable

Completed

• Conditions: Endometrial Cancer; Weight Changes
• Interventions: Procedure: quality-of-life assessment; Behavioral: behavioral dietary intervention; Other: counseling intervention; Other: educational intervention; Other: preventative dietary intervention

• Registration Number: NCT00262938
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-12-06
• Study First Submitted QC: 2005-12-06
• Study First Posted: 2005-12-07
• Primary Completion: 2006-01
• Study Completion: 2011-08
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	educational intervention	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	quality-of-life assessment	Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.
Lifestyle counseling	behavioral dietary intervention	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.
Lifestyle counseling	counseling intervention	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.
Lifestyle counseling	preventative dietary intervention	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.
Lifestyle counseling	quality-of-life assessment	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.

Primary Outcome Measures

Name	Time	Method
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
Comorbidities as measured by Charlson Co-Morbidity Score 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

Trial Locations

Locations (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States