Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262938
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2005-12-06
Brief Title:
Lifestyle Change and Quality of Life in Obese Patients With Stage III Endometrial Cancer in Remission
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 25-299 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
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 25-299 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None