Status:
UNKNOWN
Questionnaire Study to Assess Quality of Life After Treatment of Fibroids
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
Walter Reed Army Medical Center
Georgetown University
Conditions:
Leiomyoma
Eligibility:
FEMALE
35-50 years
Brief Summary
The purpose of this study is to determine the change in symptoms and health-related quality of life in patients undergoing treatment for fibroids. Results from the questionnaire will be compared with ...
Detailed Description
Uterine fibroids are the most common benign uterine tumor affecting approximately 70% of all women in the United States. Sixty percent of the 600,000 hysterectomies performed in the United States annu...
Eligibility Criteria
Inclusion
- Fibroid Treatment Group
- Pre-menopausal
- Between the ages of 35 and 50, inclusive
- Scheduled to undergo hysterectomy, myomectomy, or uterine fibroid embolization for treatment of uterine fibroids at one of the participating institutions
- Willing to provide written informed consent
- Able to speak and read English
- Normal Control Group (patients not diagnosed with fibroids)
- Pre-menopausal
- Between the ages of 35 and 50, inclusive
- Normal gynecologic examination at time of enrollment with regular menstrual cycle at the time of enrollment
- Willing to provide written informed consent
- Able to read and speak English
Exclusion
- Fibroid Treatment Group
- Currently pregnant
- Cognitive impairment that would interfere with completing the questionnaire
- Severe psychiatric co-morbidity
- Co-morbid or life-threatening condition with life expectancy to be less than 1 year
- Active duty military healthcare beneficiary
Key Trial Info
Start Date :
December 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00390494
Start Date
December 1 2005
End Date
December 1 2010
Last Update
June 30 2008
Active Locations (4)
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1
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
2
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307
3
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
4
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213