Questionnaire Study to Assess Quality of Life After Treatment of Fibroids
NCT ID: NCT00390494
Last Updated: 2008-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2005-12-31
2010-12-31
Brief Summary
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Detailed Description
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The Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QoL) was developed from focus groups of women with leiomyomata. The original items captured key symptoms and areas of life impact voiced by the focus group participants. Content validity was established through cognitive debriefings of women with leiomyomata and review by expert clinicians. The UFS-QoL was then validated in a patient population of women with leiomyomata as well as "normal" controls.
Using the UFS-Qol as the primary measure, this study will provide the basis of comparison for women with uterine fibroids both before and after therapy. "Normal" scores will be established from patients without fibroids. These data will provide the basis for comparing these outcomes to those resulting from a variety of investigational therapies. It will also provide insight into the progression of fibroid-related symptoms in patients established as normal at baseline.
The objectives of this study are:
A. To determine the change in symptoms and health-related quality of life in patients undergoing hysterectomy, myomectomy, and uterine fibroid embolization.
B. To compare the outcomes of each intervention with a normal control group as well as with the other therapies.
C. To validate the UFS-QoL questionnaire in a normal population to determine a normal score range.
D. To validate the UFS-QoL questionnaire in hysterectomy patients to determine a "normal" score for patients without a uterus.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Interventions
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Hysterectomy
Myomectomy
Uterine Fibroid Embolization
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 Criteria
* 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
* Currently pregnant
* Presence of other gynecologic-related diseases (e.g. endometriosis, pelvic inflammatory disease)
* 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
35 Years
50 Years
FEMALE
Yes
Sponsors
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Walter Reed Army Medical Center
FED
Georgetown University
OTHER
The Cleveland Clinic
OTHER
University of Pittsburgh
OTHER
U.S. Army Medical Research and Development Command
FED
Principal Investigators
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James B Spies, MD
Role: STUDY_DIRECTOR
Georgetown University Hospital
LTC G. Larry Maxwell, MD
Role: PRINCIPAL_INVESTIGATOR
Walter Reed Army Medical Center
Richard Guido, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Linda D Bradley, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Georgetown University Hospital
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Countries
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References
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Spies JB, Bradley LD, Guido R, Maxwell GL, Levine BA, Coyne K. Outcomes from leiomyoma therapies: comparison with normal controls. Obstet Gynecol. 2010 Sep;116(3):641-652. doi: 10.1097/AOG.0b013e3181ed36b3.
Other Identifiers
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A-12818.2a
Identifier Type: -
Identifier Source: secondary_id
04-44020
Identifier Type: -
Identifier Source: org_study_id