Questionnaire Study to Assess Quality of Life After Treatment of Fibroids
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|ClinicalTrials.gov Identifier: NCT00390494|
Recruitment Status : Unknown
Verified June 2008 by Walter Reed Army Medical Center.
Recruitment status was: Active, not recruiting
First Posted : October 19, 2006
Last Update Posted : June 30, 2008
|Condition or disease||Intervention/treatment|
|Leiomyoma||Procedure: Hysterectomy Procedure: Myomectomy Procedure: Uterine Fibroid Embolization|
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 annually are done because of uterine fibroids. Hysterectomy has been the definitive treatment for fibroids and has been demonstrated to be effective in controlling symptoms. However, there have been few studies comparing the outcome of hysterectomy to other surgical and non-surgical therapies or to the outcomes experienced by a "normal" population, i.e. those not diagnosed with fibroids. Similarly, the relative effectiveness of myomectomy and uterine fibroid embolization has not been evaluated in the context of other fibroid therapies and minimally invasive variations. Fibroid symptoms experienced by patients are subjective and have not been shown to correlate with fibroid number, size, location, or any other clinical measure of fibroids. As symptoms and their impact are the primary outcomes experienced by patients, a validated questionnaire to measure this impact is needed.
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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Outcome From Fibroid Therapies: A Comparison With Normal Controls|
|Study Start Date :||December 2005|
|Study Completion Date :||December 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390494
|United States, District of Columbia|
|Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307|
|United States, Ohio|
|The Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Study Director:||James B Spies, MD||Georgetown University Hospital|
|Principal Investigator:||LTC G. Larry Maxwell, MD||Walter Reed Army Medical Center|
|Principal Investigator:||Richard Guido, MD||Magee-Womens Hospital|
|Principal Investigator:||Linda D Bradley, MD||The Cleveland Clinic|