Decisionmaking for Abnormal Uterine Bleeding (AUB)

April 21, 2015 updated by: Lisa Hess, Indiana University

Decision Making Among Treatment Alternatives for Abnormal Uterine Bleeding (AUB)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • North Carolina
      • Southern Pines, North Carolina, United States, 28388
        • Southern Pines Women's Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in patient-reported satisfaction between treatment groups
Time Frame: 6 weeks
Satisfaction with care as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Scale (FACT-TS-PS)
6 weeks
Differences in decision regret between treatment groups
Time Frame: 6 weeks
Decision regret is measured by the Decision Regret Scale
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Lisa M Hess, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

November 1, 2012

First Posted (Estimate)

November 4, 2012

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1009001853 (0904-66B)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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