Text Size

Decisionmaking for Abnormal Uterine Bleeding (AUB)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lisa Hess, Indiana University
ClinicalTrials.gov Identifier:
NCT01721304
First received: October 25, 2012
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study is a two-part study. The first pilot tests the computerized tool to ensure it is understood by patients, then the second part is a randomized study (computerized tool versus usual care) to see if improvements are made in satisfaction and if there are reductions in decision regret.


Condition Intervention
Abnormal Uterine Bleeding
 Other: Adaptive Conjoint Analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Decision Making Among Treatment Alternatives for Abnormal Uterine Bleeding (AUB)

Resource links provided by NLM:

MedlinePlus related topics: Vaginal Bleeding
U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Differences in patient-reported satisfaction between treatment groups [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Satisfaction with care as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Scale (FACT-TS-PS)

  • Differences in decision regret between treatment groups [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Decision regret is measured by the Decision Regret Scale


Enrollment: 380
Study Start Date: May 2009
Estimated Study Completion Date: August 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adaptive Conjoint Analysis
Computerized survey to elicit preferences
 Other: Adaptive Conjoint Analysis
Computerized survey to elicit patient preferences
No Intervention: Usual care
Patients are counseled by their physician as usual

Detailed Description:

The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study was designed to develop and test the use of ACA as part of routine clinical care for women diagnosed with AUB. After pilot testing, the ACA survey is administered in this study where patients are assigned to receive the ACA or to usual care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have received a diagnosis of dysfunctional or abnormal uterine bleeding (AUB) that is recommended for treatment
  • Have not yet selected or initiated treatment for current AUB diagnosis
  • Be at least 18 years of age.
  • Be possible candidates for either medical or surgical therapy
  • Able to provide informed consent for treatment options for oneself

Exclusion Criteria:

  • Are currently being treated for cancer
  • Any cancer diagnosis within the past 2 years (other than non-melanoma skin cancer)
  • AUB due to serious pelvic pathology, medications, pregnancy or systemic disease that limits their range of treatment options
  • Are not recommended for surgical intervention
  • Are not recommended for medical intervention
  • Are under 18 years of age
  • Have not received a diagnosis of AUB
  • Are currently being treated for AUB
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721304

Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, North Carolina
Southern Pines Women's Health Center
Southern Pines, North Carolina, United States, 28388
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Lisa M Hess, PhD Indiana University
  More Information

No publications provided

Responsible Party: Lisa Hess, Assistant Professor of Medicine and Public Health, Indiana University
ClinicalTrials.gov Identifier: NCT01721304     History of Changes
Other Study ID Numbers: 1009001853 (0904-66B)
Study First Received: October 25, 2012
Last Updated: November 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
decision making
abnormal uterine bleeding
adaptive conjoint analysis
satisfaction
regret

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013