Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390494
Status:
UNKNOWN
Last Update Posted:
2008-06-30
First Post:
2006-10-17
Brief Title:
Questionnaire Study to Assess Quality of Life After Treatment of Fibroids
Sponsor:
US Army Medical Research and Development Command
Organization:
Walter Reed Army Medical Center
Study Overview
Official Title:
Outcome From Fibroid Therapies A Comparison With Normal Controls
Status:
UNKNOWN
Status Verified Date:
2008-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 600000 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 ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A-128182a | None | None | None |