LeiomyomaNCT00390494
Questionnaire Study to Assess Quality of Life After Treatment of Fibroids
An observational study of Leiomyoma, run by U.S. Army Medical Research and Development Command at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma
- What is being tested?
- Hysterectomy, Myomectomy and Uterine Fibroid Embolization
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2005to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: 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.
Read the 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.
- Conditions
- Leiomyoma
- Being tested
- Hysterectomy, Myomectomy, Uterine Fibroid Embolization
- Keywords
- Fibroids, Leiomyoma, Hysterectomy, Myomectomy, Uterine Fibroid Embolization, Questionnaire
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysterectomyProcedure or surgery
MyomectomyProcedure or surgery
Uterine Fibroid EmbolizationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startDec 2005
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Medical Center, Georgetown University, The Cleveland Clinic, University of Pittsburgh
- Investigators
- James B Spies, MD, Study director, Georgetown University HospitalLTC G. Larry Maxwell, MD, Principal investigator, Walter Reed Army Medical CenterRichard Guido, MD, Principal investigator, University of PittsburghLinda D Bradley, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390494
- Sponsor's protocol ID
- 04-44020
- Other IDs
- A-12818.2a
- Status last verified
- Jun 2008
- First submitted
- 17 Oct 2006
- Last updated
- 30 Jun 2008
- Results posted
- No
Publications
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.
PubMed 20733447
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome From Fibroid Therapies: A Comparison With Normal Controls
- ClinicalTrials.gov ID
- NCT00390494
- Acronym / sponsor ID
- 04-44020
- Conditions
- Leiomyoma
- Keywords
- Fibroids, Leiomyoma, Hysterectomy, Myomectomy, Uterine Fibroid Embolization, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Medical Center, Georgetown University, The Cleveland Clinic, University of Pittsburgh
- Study start
- Dec 2005
- Study completion
- Dec 2010
- First posted
- 19 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysterectomy | Procedure or surgery | – |
| Myomectomy | Procedure or surgery | – |
| Uterine Fibroid Embolization | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2008.
- Derived from this study: PubMed 20733447Spies 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James B Spies, MD study director
Georgetown University Hospital
LTC G. Larry Maxwell, MD principal investigator
Walter Reed Army Medical Center
Richard Guido, MD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiomyoma, run by U.S. Army Medical Research and Development Command at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00390494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2008.