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Decisionmaking for Abnormal Uterine Bleeding (AUB)

This study has been completed.
Information provided by (Responsible Party):
Lisa Hess, Indiana University Identifier:
First received: October 25, 2012
Last updated: April 21, 2015
Last verified: April 2015
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:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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)

  • Differences in decision regret between treatment groups [ Time Frame: 6 weeks ]
    Decision regret is measured by the Decision Regret Scale

Enrollment: 380
Study Start Date: May 2009
Study Completion Date: August 2012
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01721304

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
Principal Investigator: Lisa M Hess, PhD Indiana University
  More Information

Additional Information:
Responsible Party: Lisa Hess, Assistant Professor of Medicine and Public Health, Indiana University Identifier: NCT01721304     History of Changes
Other Study ID Numbers: 1009001853 (0904-66B)
Study First Received: October 25, 2012
Last Updated: April 21, 2015

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

Additional relevant MeSH terms:
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female processed this record on April 27, 2017