<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/NCT02239328</url>
  </required_header>
  <id_info>
    <org_study_id>17525</org_study_id>
    <nct_id>NCT02239328</nct_id>
  </id_info>
  <brief_title>A Study of Patient-reported Outcomes in Patients With Lung or Esophageal Cancer</brief_title>
  <official_title>A Study of Patient-reported Outcomes in Patients With Lung or Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alliance for Clinical Trials in Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This survey study is looking to determine if patient reported outcomes(using the PROMIS&#xD;
      survey) will vary according to the presence of recurrent or metastatic lung or esophageal&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A patient-centered approach to lung cancer surveillance following resection needs to&#xD;
      incorporate patient reported outcomes. The Patient Reported Outcomes Measurement Information&#xD;
      System (PROMIS®) was designed to revolutionize the assessment of patient reported outcomes by&#xD;
      establishing a national resource for the measurement of patient-reported symptoms and other&#xD;
      health outcomes.&#xD;
&#xD;
      The PROMIS Assessment Center, the management tool within the larger PROMIS system, will be&#xD;
      used to securely store de identified data, provide automated accrual reports and data export&#xD;
      for this specific study. This study will have it's own study specific website.&#xD;
&#xD;
      Patients seen at the University of Virginia Cancer Center will be identified and invited to&#xD;
      participate in an assessment of their reported outcomes over multiple domains available in&#xD;
      PROMIS. Collecting this information on lung cancer survivors may provide a robust platform to&#xD;
      design a patient-centered surveillance strategy following resection.&#xD;
&#xD;
      The study team hypothesizes that patient reported outcomes will vary according to the&#xD;
      presence of recurrence or metastasis of lung or esophageal cancer. The study team also&#xD;
      believes including patient reported outcomes into routine post-treatment surveillance will&#xD;
      improve patient satisfaction and improve outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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 Reported Outcomes Measurement Information System (PROMIS) Scores.</measure>
    <time_frame>Over a 3 year period</time_frame>
    <description>Enrolled subjects with lung or esophageal cancer will be asked to complete an on-line (web-based) survey (PROMIS) using a computer. Most patients will only be asked to complete this survey once, but some patients will be asked to answer the questions a second or third time over a maximum five year period. The PROMIS assessment center was used to develop and administer patient reported outcomes (PROs) for each of these five cancer domains. PROMIS scores are continuous and range from 0-100. Total scores were calculated and calibrated to the weighted distribution of scores from a large representative sample of the U.S. general population using the 'T-score' algorithm 18. The T-scores for the study population are calibrated to the surveyed population mean of 50 and standard deviation of 10, such that a study patient with a T-score of 40 is one standard deviation below the U.S. general population mean.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">182</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>Lung Cancer, Esophageal Cancer</arm_group_label>
    <description>Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Lung cancer Esophageal cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Suspected or Known diagnosis of lung or esophageal cancer&#xD;
&#xD;
          -  Willing and able to complete questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects unwilling to provide informed consent&#xD;
&#xD;
          -  Subjects unwilling or unable to answer the questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin Kozower, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>July 13, 2017</results_first_submitted>
  <results_first_submitted_qc>January 8, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 26, 2018</results_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Benjamin Kozower, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Lung cancer</keyword>
  <keyword>esophageal cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 31, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02239328/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 31, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02239328/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were screened and recruited in the Thoracic surgery clinic during their appointments. Subject recruitment began on 08/20/2014 and was completed on 11/20/2015.</recruitment_details>
      <pre_assignment_details>There was no wash out or run-in period for this study. Subjects were consented and then immediately completed the survey.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lung Cancer, Esophageal Cancer</title>
          <description>Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="182"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Benign disease noted at time of surgery</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Equipment or website malfunction</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lung Cancer, Esophageal Cancer</title>
          <description>Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="174"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.8" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="174"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current smokers</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Outcomes Measurement Information System (PROMIS) Scores.</title>
        <description>Enrolled subjects with lung or esophageal cancer will be asked to complete an on-line (web-based) survey (PROMIS) using a computer. Most patients will only be asked to complete this survey once, but some patients will be asked to answer the questions a second or third time over a maximum five year period. The PROMIS assessment center was used to develop and administer patient reported outcomes (PROs) for each of these five cancer domains. PROMIS scores are continuous and range from 0-100. Total scores were calculated and calibrated to the weighted distribution of scores from a large representative sample of the U.S. general population using the 'T-score' algorithm 18. The T-scores for the study population are calibrated to the surveyed population mean of 50 and standard deviation of 10, such that a study patient with a T-score of 40 is one standard deviation below the U.S. general population mean.</description>
        <time_frame>Over a 3 year period</time_frame>
        <population>All patients who completed at least 1 PROMIS survey who had a diagnosis of lung cancer.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer, Esophageal Cancer</title>
            <description>Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Outcomes Measurement Information System (PROMIS) Scores.</title>
          <description>Enrolled subjects with lung or esophageal cancer will be asked to complete an on-line (web-based) survey (PROMIS) using a computer. Most patients will only be asked to complete this survey once, but some patients will be asked to answer the questions a second or third time over a maximum five year period. The PROMIS assessment center was used to develop and administer patient reported outcomes (PROs) for each of these five cancer domains. PROMIS scores are continuous and range from 0-100. Total scores were calculated and calibrated to the weighted distribution of scores from a large representative sample of the U.S. general population using the 'T-score' algorithm 18. The T-scores for the study population are calibrated to the surveyed population mean of 50 and standard deviation of 10, such that a study patient with a T-score of 40 is one standard deviation below the U.S. general population mean.</description>
          <population>All patients who completed at least 1 PROMIS survey who had a diagnosis of lung cancer.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Function</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.05" spread="8.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.51" spread="9.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.64" spread="8.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.74" spread="9.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.45" spread="9.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Multilevel random coefficient models estimated the mean score of each PROMIS domain as a function of time elapsed between date of surgery and assessment (in years), and patient comorbidity. Statistical significance of estimated fixed effects were assessed by the F-test statistic for type 3 tests, p &lt; 0.05.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Over a 3 year period</time_frame>
      <desc>An adverse event will be considered any undesirable sign, symptom or medical condition considered related to the intervention. Medical conditions/ diseases present before starting the intervention will be considered adverse events only if they worsen after starting the study and that worsening is considered to be related to the study intervention. OR any undesirable and unintended effect of research occurring in human subjects as a result of collection of private identifiable information.</desc>
      <group_list>
        <group group_id="E1">
          <title>Lung Cancer, Esophageal Cancer</title>
          <description>Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Benjamin Kozower</name_or_title>
      <organization>Washington University</organization>
      <phone>314-362-8089</phone>
      <email>kozower@wustl.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02239328
org study id: 17525
nct id: NCT02239328
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This survey study is looking to determine if patient reported outcomes(using the PROMIS
      survey) will vary according to the presence of recurrent or metastatic lung or esophageal
      cancer.
A patient-centered approach to lung cancer surveillance following resection needs to
      incorporate patient reported outcomes. The Patient Reported Outcomes Measurement Information
      System (PROMIS®) was designed to revolutionize the assessment of patient reported outcomes by
      establishing a national resource for the measurement of patient-reported symptoms and other
      health outcomes.

      The PROMIS Assessment Center, the management tool within the larger PROMIS system, will be
      used to securely store de identified data, provide automated accrual reports and data export
      for this specific study. This study will have it's own study specific website.

      Patients seen at the University of Virginia Cancer Center will be identified and invited to
      participate in an assessment of their reported outcomes over multiple domains available in
      PROMIS. Collecting this information on lung cancer survivors may provide a robust platform to
      design a patient-centered surveillance strategy following resection.

      The study team hypothesizes that patient reported outcomes will vary according to the
      presence of recurrence or metastasis of lung or esophageal cancer. The study team also
      believes including patient reported outcomes into routine post-treatment surveillance will
      improve patient satisfaction and improve outcomes.
observational model: Cohort
time perspective: Prospective
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Scores.
time frame: Over a 3 year period
description: Enrolled subjects with lung or esophageal cancer will be asked to complete an on-line (web-based) survey (PROMIS) using a computer. Most patients will only be asked to complete this survey once, but some patients will be asked to answer the questions a second or third time over a maximum five year period. The PROMIS assessment center was used to develop and administer patient reported outcomes (PROs) for each of these five cancer domains. PROMIS scores are continuous and range from 0-100. Total scores were calculated and calibrated to the weighted distribution of scores from a large representative sample of the U.S. general population using the 'T-score' algorithm 18. The T-scores for the study population are calibrated to the surveyed population mean of 50 and standard deviation of 10, such that a study patient with a T-score of 40 is one standard deviation below the U.S. general population mean.
arm group label: Lung Cancer, Esophageal Cancer
description: Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Kozower, MD
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Benjamin Kozower, MD
investigator title: Principal Investigator
mesh term: Esophageal Neoplasms
sharing ipd: Yes
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 