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Decisionmaking for Abnormal Uterine Bleeding (AUB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01721304
First Posted: November 5, 2012
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lisa Hess, Indiana University
  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: None (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 Lisa Hess, 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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
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)
First Submitted: October 25, 2012
First Posted: November 5, 2012
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Lisa Hess, 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