<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/NCT03251976</url>
  </required_header>
  <id_info>
    <org_study_id>F12345678</org_study_id>
    <nct_id>NCT03251976</nct_id>
  </id_info>
  <brief_title>CPR Decision Aid For Patients With Advanced Gynecologic Malignancies</brief_title>
  <official_title>The Effect of a CPR Decision Aid on CPR Knowledge and Code-Status Preferences in Patients With Advanced Gynecologic Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR)&#xD;
      decision aid video on CPR knowledge and end-of-life preferences in women with advanced&#xD;
      gynecologic malignancy. We will assess the baseline CPR knowledge in our research population,&#xD;
      gauge the improvement after viewing a decision aid video, and evaluate its effects on patient&#xD;
      preferences regarding CPR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Actual">May 6, 2019</completion_date>
  <primary_completion_date type="Actual">May 6, 2019</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CPR knowledge</measure>
    <time_frame>one month after intervention</time_frame>
    <description>Patient CPR knowledge assessment score (0-4)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CPR preference</measure>
    <time_frame>baseline</time_frame>
    <description>Patient CPR preference (Yes, No, Unsure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CPR preference</measure>
    <time_frame>one month after intervention</time_frame>
    <description>Patient CPR preference (Yes, No, Unsure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CPR knowledge</measure>
    <time_frame>baseline</time_frame>
    <description>Patient CPR knowledge assessment score (0-4)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Advance Care Planning</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>video decision aid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>video</intervention_name>
    <description>informational video</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>usual care</intervention_name>
    <description>usual physician counseling on end of life care</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with stage III or greater cervical, ovarian, or uterine malignancies&#xD;
&#xD;
          -  receiving chemotherapy at UAB gynecologic oncology infusion center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  early stage gynecologic cancer&#xD;
&#xD;
          -  receiving chemotherapy at a different location&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  deafness&#xD;
&#xD;
          -  blindness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kerri Bevis, MD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 15, 2019</last_update_submitted>
  <last_update_submitted_qc>August 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Kerri Bevis</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>ovarian cancer</keyword>
  <keyword>cardiopulmonary resuscitation</keyword>
  <keyword>end of life care</keyword>
  <keyword>endometrial cancer</keyword>
  <keyword>cervical cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03251976
org study id: F12345678
nct id: NCT03251976
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR)
      decision aid video on CPR knowledge and end-of-life preferences in women with advanced
      gynecologic malignancy. We will assess the baseline CPR knowledge in our research population,
      gauge the improvement after viewing a decision aid video, and evaluate its effects on patient
      preferences regarding CPR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: CPR knowledge
time frame: one month after intervention
description: Patient CPR knowledge assessment score (0-4)
measure: CPR preference
time frame: baseline
description: Patient CPR preference (Yes, No, Unsure)
measure: CPR preference
time frame: one month after intervention
description: Patient CPR preference (Yes, No, Unsure)
measure: CPR knowledge
time frame: baseline
description: Patient CPR knowledge assessment score (0-4)
arm group label: Intervention
arm group type: Experimental
description: video decision aid
arm group label: Usual care
arm group type: Active Comparator
intervention type: Behavioral
intervention name: video
description: informational video
arm group label: Intervention
intervention type: Behavioral
intervention name: usual care
description: usual physician counseling on end of life care
arm group label: Usual care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Kerri Bevis, MD, MSPH
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Kerri Bevis
investigator title: Associate Professor
mesh term: Neoplasms
sharing ipd: No