<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/NCT02190864</url>
  </required_header>
  <id_info>
    <org_study_id>318-13-EP</org_study_id>
    <nct_id>NCT02190864</nct_id>
  </id_info>
  <brief_title>Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients</brief_title>
  <official_title>Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our long-term goal is to integrate non-small cell lung cancer patient treatment preferences&#xD;
      into clinical treatment planning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The following specific aims are proposed:&#xD;
&#xD;
      Aim 1: Determine whether individual patients' preferences, characteristics, and treatment&#xD;
      experiences affect the definition of treatment success.&#xD;
&#xD;
      Aim 2: Determine how to best predict real-life patients' treatment choices based on patients'&#xD;
      preferences of adverse events.&#xD;
&#xD;
      Aim 3: Determine whether physicians are likely to change their oncologic clinical practice&#xD;
      after receiving a detailed communication of their patients' preferences of adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-defined &quot;treatment success&quot;</measure>
    <time_frame>Baseline</time_frame>
    <description>In advanced stage NSCLC patients does patient-defined &quot;treatment success&quot; differ when both survival and patient preferences of adverse events are accounted for, compared to when success is measured solely by survival? And does it also differ based on individual patient characteristics?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients' will to experience adverse events</measure>
    <time_frame>Baseline</time_frame>
    <description>Will the serious adverse events that an advanced stage NSCLC patient is willing to experience as part of his/her treatment differ after a real-life treatment experience, compared to before treatment?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Summary score derived from patient preferences of adverse events</measure>
    <time_frame>Up to three months</time_frame>
    <description>In advanced stage NSCLC patients, is a summary score derived from patient preferences of adverse events comparable to a real-life treatment scenario?</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physicians' will to select a treatment</measure>
    <time_frame>Two years</time_frame>
    <description>Are physicians treating NSCLC patients more likely to select a treatment that matches patients' drug choices when provided standardized, detailed information on patients' preferences of adverse events compared to when they follow regular clinical practice?</description>
  </other_outcome>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Particularly Rural/Urban Residence</condition>
  <condition>Gender</condition>
  <condition>Age</condition>
  <condition>FACT-TOI Scores</condition>
  <condition>Comorbid Conditions</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed advanced stage non-small cell lung cancer patients with age &gt; 19 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide consent&#xD;
&#xD;
          -  Greater than or equal to 19 years of age&#xD;
&#xD;
          -  Diagnosed with stage IV non-small cell lung cancer (NSCLC)&#xD;
&#xD;
          -  Able to understand spoken English&#xD;
&#xD;
          -  Eligible to undergo chemotherapy for stage IV NSCLC, to include, but not limited to,&#xD;
             those who:&#xD;
&#xD;
               1. have not yet started chemo&#xD;
&#xD;
               2. are currently undergoing chemo for stage IV NSCLC&#xD;
&#xD;
               3. have completed first line stage IV NSCLC chemo or progressed to maintenance for&#xD;
                  stage IV NSCLC within the last 30 days&#xD;
&#xD;
               4. elect to have chemo elsewhere -- not at one of the study sites&#xD;
&#xD;
               5. decline chemo&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;19 years&#xD;
&#xD;
          -  Not willing and/or able to provide consent&#xD;
&#xD;
          -  Not able to understand spoken English&#xD;
&#xD;
          -  Not eligible to undergo chemotherapy for stage IV NSCLC&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KM Munirul Islam, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>KM Munirul Islam, MD, PhD</last_name>
    <phone>402-559-8283</phone>
    <email>kmislam@unmc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612-9416</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jhanelle E Gray, MD</last_name>
      <phone>813-745-6895</phone>
      <email>katie.james@moffitt.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kansas City VA Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Spancer, RN</last_name>
      <phone>816-861-4700</phone>
      <phone_ext>57665</phone_ext>
      <email>sarah.spancer@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Francis Cancer Treatment Center</name>
      <address>
        <city>Grand Island</city>
        <state>Nebraska</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Southeast Nebraska Cancer center</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>bronson Riley, MS</last_name>
      <phone>402-327-7363</phone>
      <email>bronsonr@leadingcancercare.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Callahan Cancer Center of Great Plains Regional Medical Center</name>
      <address>
        <city>North Platte</city>
        <state>Nebraska</state>
        <zip>69101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irfan A Vaziri, MD</last_name>
      <phone>308-696-7864</phone>
      <email>vazirii@gprmc.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nebraska-Western Iowa (NWI) VA Health Care System</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joy Egan, RN</last_name>
      <phone>402-995-4143</phone>
      <email>joy.egan@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>KM Munirul Islam, MD, PhD</last_name>
      <phone>402-559-8283</phone>
      <email>kmislam@unmc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Avera Cancer Institute</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://pcori.org/</url>
    <description>Patient Centered Outcomes Research Institute</description>
  </link>
  <link>
    <url>http://www.saintfrancisgi.org/</url>
    <description>Saint Francis Cancer Treatment Center</description>
  </link>
  <link>
    <url>http://www.unmc.edu/</url>
    <description>University of Nebraska Medical Center</description>
  </link>
  <link>
    <url>https://net.unmc.edu/rss/</url>
    <description>UNMC IRB</description>
  </link>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>December 3, 2015</last_update_submitted>
  <last_update_submitted_qc>December 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>KM Islam, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>February 28, 2017</submitted>
    <returned>April 11, 2017</returned>
    <submitted>December 11, 2017</submitted>
    <returned>October 5, 2018</returned>
  </pending_results>
  <!-- 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/NCT02190864
org study id: 318-13-EP
nct id: NCT02190864
lead sponsor: 
collaborator: 
has dmc: No
Our long-term goal is to integrate non-small cell lung cancer patient treatment preferences
      into clinical treatment planning.
The following specific aims are proposed:

      Aim 1: Determine whether individual patients' preferences, characteristics, and treatment
      experiences affect the definition of treatment success.

      Aim 2: Determine how to best predict real-life patients' treatment choices based on patients'
      preferences of adverse events.

      Aim 3: Determine whether physicians are likely to change their oncologic clinical practice
      after receiving a detailed communication of their patients' preferences of adverse events.
observational model: Cohort
time perspective: Prospective
measure: Patient-defined "treatment success"
time frame: Baseline
description: In advanced stage NSCLC patients does patient-defined "treatment success" differ when both survival and patient preferences of adverse events are accounted for, compared to when success is measured solely by survival? And does it also differ based on individual patient characteristics?
measure: Patients' will to experience adverse events
time frame: Baseline
description: Will the serious adverse events that an advanced stage NSCLC patient is willing to experience as part of his/her treatment differ after a real-life treatment experience, compared to before treatment?
measure: Summary score derived from patient preferences of adverse events
time frame: Up to three months
description: In advanced stage NSCLC patients, is a summary score derived from patient preferences of adverse events comparable to a real-life treatment scenario?
measure: Physicians' will to select a treatment
time frame: Two years
description: Are physicians treating NSCLC patients more likely to select a treatment that matches patients' drug choices when provided standardized, detailed information on patients' preferences of adverse events compared to when they follow regular clinical practice?
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: KM Munirul Islam, MD, PhD
role: Principal Investigator
affiliation: University of Nebraska
last name: KM Munirul Islam, MD, PhD
phone: 402-559-8283
email: kmislam@unmc.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
country: United States
url: http://pcori.org/
description: Patient Centered Outcomes Research Institute
url: http://www.saintfrancisgi.org/
description: Saint Francis Cancer Treatment Center
url: http://www.unmc.edu/
description: University of Nebraska Medical Center
url: https://net.unmc.edu/rss/
description: UNMC IRB
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: KM Islam, PhD
investigator title: Principal Investigator
submitted: February 28, 2017
returned: April 11, 2017
submitted: December 11, 2017
returned: October 5, 2018