<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01721304</url>
  </required_header>
  <id_info>
    <org_study_id>1009001853 (0904-66B)</org_study_id>
    <nct_id>NCT01721304</nct_id>
  </id_info>
  <brief_title>Decisionmaking for Abnormal Uterine Bleeding (AUB)</brief_title>
  <official_title>Decision Making Among Treatment Alternatives for Abnormal Uterine Bleeding (AUB)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if using a computer survey about preferences for&#xD;
      treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient&#xD;
      satisfaction with clinical care and decision making. This study is a two-part study. The&#xD;
      first pilot tests the computerized tool to ensure it is understood by patients, then the&#xD;
      second part is a randomized study (computerized tool versus usual care) to see if&#xD;
      improvements are made in satisfaction and if there are reductions in decision regret.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine if using a computer survey about preferences for&#xD;
      treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient&#xD;
      satisfaction with clinical care and decision making. This study was designed to develop and&#xD;
      test the use of ACA as part of routine clinical care for women diagnosed with AUB. After&#xD;
      pilot testing, the ACA survey is administered in this study where patients are assigned to&#xD;
      receive the ACA or to usual care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in patient-reported satisfaction between treatment groups</measure>
    <time_frame>6 weeks</time_frame>
    <description>Satisfaction with care as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Scale (FACT-TS-PS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in decision regret between treatment groups</measure>
    <time_frame>6 weeks</time_frame>
    <description>Decision regret is measured by the Decision Regret Scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">380</enrollment>
  <condition>Abnormal Uterine Bleeding</condition>
  <arm_group>
    <arm_group_label>Adaptive Conjoint Analysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computerized survey to elicit preferences</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients are counseled by their physician as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adaptive Conjoint Analysis</intervention_name>
    <description>Computerized survey to elicit patient preferences</description>
    <arm_group_label>Adaptive Conjoint Analysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have received a diagnosis of dysfunctional or abnormal uterine bleeding (AUB) that is&#xD;
             recommended for treatment&#xD;
&#xD;
          -  Have not yet selected or initiated treatment for current AUB diagnosis&#xD;
&#xD;
          -  Be at least 18 years of age.&#xD;
&#xD;
          -  Be possible candidates for either medical or surgical therapy&#xD;
&#xD;
          -  Able to provide informed consent for treatment options for oneself&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are currently being treated for cancer&#xD;
&#xD;
          -  Any cancer diagnosis within the past 2 years (other than non-melanoma skin cancer)&#xD;
&#xD;
          -  AUB due to serious pelvic pathology, medications, pregnancy or systemic disease that&#xD;
             limits their range of treatment options&#xD;
&#xD;
          -  Are not recommended for surgical intervention&#xD;
&#xD;
          -  Are not recommended for medical intervention&#xD;
&#xD;
          -  Are under 18 years of age&#xD;
&#xD;
          -  Have not received a diagnosis of AUB&#xD;
&#xD;
          -  Are currently being treated for AUB&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa M Hess, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Pines Women's Health Center</name>
      <address>
        <city>Southern Pines</city>
        <state>North Carolina</state>
        <zip>28388</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/25074354</url>
    <description>Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial.</description>
  </link>
  <results_reference>
    <citation>Hess LM, Litwiller A, Byron J, Stutsman J, Kasper K, Learman LA. Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial. Patient. 2015 Apr;8(2):217-27. doi: 10.1007/s40271-014-0078-8.</citation>
    <PMID>25074354</PMID>
  </results_reference>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>April 21, 2015</last_update_submitted>
  <last_update_submitted_qc>April 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Lisa Hess</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine and Public Health</investigator_title>
  </responsible_party>
  <keyword>decision making</keyword>
  <keyword>abnormal uterine bleeding</keyword>
  <keyword>adaptive conjoint analysis</keyword>
  <keyword>satisfaction</keyword>
  <keyword>regret</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01721304
org study id: 1009001853 (0904-66B)
nct id: NCT01721304
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Differences in patient-reported satisfaction between treatment groups
time frame: 6 weeks
description: Satisfaction with care as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Scale (FACT-TS-PS)
measure: Differences in decision regret between treatment groups
time frame: 6 weeks
description: Decision regret is measured by the Decision Regret Scale
arm group label: Adaptive Conjoint Analysis
arm group type: Experimental
description: Computerized survey to elicit preferences
arm group label: Usual care
arm group type: No Intervention
description: Patients are counseled by their physician as usual
intervention type: Other
intervention name: Adaptive Conjoint Analysis
description: Computerized survey to elicit patient preferences
arm group label: Adaptive Conjoint Analysis
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lisa M Hess, PhD
role: Principal Investigator
affiliation: Indiana University
facility: 
facility: 
country: United States
url: http://www.ncbi.nlm.nih.gov/pubmed/25074354
description: Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial.
citation: Hess LM, Litwiller A, Byron J, Stutsman J, Kasper K, Learman LA. Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial. Patient. 2015 Apr;8(2):217-27. doi: 10.1007/s40271-014-0078-8.
PMID: 25074354
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Lisa Hess
investigator title: Assistant Professor of Medicine and Public Health
mesh term: Uterine Hemorrhage
mesh term: Hemorrhage