Questionnaire Study to Assess Quality of Life After Treatment of Fibroids

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Walter Reed Army Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Walter Reed Army Medical Center
Georgetown University
The Cleveland Clinic
Magee-Womens Hospital
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00390494
First received: October 17, 2006
Last updated: June 26, 2008
Last verified: June 2008
  Purpose

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 Intervention
Leiomyoma
Procedure: Hysterectomy
Procedure: Myomectomy
Procedure: Uterine Fibroid Embolization

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Outcome From Fibroid Therapies: A Comparison With Normal Controls

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Estimated Enrollment: 400
Study Start Date: December 2005
Estimated Study Completion Date: December 2010
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.

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390494

Locations
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
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Medical Center
Georgetown University
The Cleveland Clinic
Magee-Womens Hospital
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 Magee-Womens Hospital
Principal Investigator: Linda D Bradley, MD The Cleveland Clinic
  More Information

No publications provided by Walter Reed Army Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00390494     History of Changes
Other Study ID Numbers: 04-44020, A-12818.2a
Study First Received: October 17, 2006
Last Updated: June 26, 2008
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Fibroids
Leiomyoma
Hysterectomy
Myomectomy
Uterine Fibroid Embolization
Questionnaire

Additional relevant MeSH terms:
Leiomyoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on October 23, 2014