Questionnaire Study to Assess Quality of Life After Treatment of Fibroids

Sponsor

U.S. Army Medical Research and Development Command (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT00390494

Collaborator

Walter Reed Army Medical Center (U.S. Fed), Georgetown University (Other), The Cleveland Clinic (Other), University of Pittsburgh (Other)

400

Enrollment

Locations

Duration (Months)

100

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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 results obtained from patients who do not have fibroids in order to determine a score range that differentiates these two groups.

Condition or Disease	Intervention/Treatment	Phase
Leiomyoma	Procedure: Hysterectomy Procedure: Myomectomy Procedure: Uterine Fibroid Embolization

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 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:

To determine the change in symptoms and health-related quality of life in patients undergoing hysterectomy, myomectomy, and uterine fibroid embolization.
To compare the outcomes of each intervention with a normal control group as well as with the other therapies.
To validate the UFS-QoL questionnaire in a normal population to determine a normal score range.
To validate the UFS-QoL questionnaire in hysterectomy patients to determine a "normal" score for patients without a uterus.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Time Perspective:

Prospective

Official Title:

Outcome From Fibroid Therapies: A Comparison With Normal Controls

Study Start Date :

Dec 1, 2005

Study Completion Date :

Dec 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: 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

Inclusion Criteria: 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 Criteria: 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

Exclusion Criteria: Normal Control Group

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown University Hospital	Washington	District of Columbia	United States	20007
2	Walter Reed Army Medical Center	Washington	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

Sponsors and Collaborators

U.S. Army Medical Research and Development Command
Walter Reed Army Medical Center
Georgetown University
The Cleveland Clinic
University of Pittsburgh

Investigators

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, University of Pittsburgh
Principal Investigator: Linda D Bradley, MD, The Cleveland Clinic