Questionnaire Study to Assess Quality of Life After Treatment of Fibroids

NCT00390494 | Unknown

• 2 other identifiers: 04-44020A-12818.2a
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Leiomyoma

Keywords

Fibroids; Leiomyoma; Hysterectomy; Myomectomy; Uterine Fibroid Embolization; Questionnaire

Interventions

Hysterectomy PROCEDURE

Myomectomy PROCEDURE

Uterine Fibroid Embolization PROCEDURE

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (4)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 20733447 DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

Hysterectomy; Uterine Myomectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• James B Spies, MD

  Georgetown University Hospital

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 19, 2006
• Study Start: December 1, 2005
• Study Completion: December 1, 2010
• Last Updated: June 30, 2008

Record last verified: 2008-06

Locations

US (4)