Questionnaire Study to Assess Quality of Life After Treatment of Fibroids

June 26, 2008 updated by: U.S. Army Medical Research and Development Command

Outcome From Fibroid Therapies: A Comparison With Normal Controls

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

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

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Collaborators

Georgetown University
University of Pittsburgh
The Cleveland Clinic
Walter Reed Army Medical Center

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion

December 1, 2010

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (Estimate)

October 19, 2006

Study Record Updates

Last Update Posted (Estimate)

June 30, 2008

Last Update Submitted That Met QC Criteria

June 26, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-44020
  • A-12818.2a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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