<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/NCT01687738</url>
  </required_header>
  <id_info>
    <org_study_id>11-0992</org_study_id>
    <secondary_id>121218-RSG-05-217-05-CPPB</secondary_id>
    <nct_id>NCT01687738</nct_id>
  </id_info>
  <brief_title>Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention</brief_title>
  <official_title>Lung Cancer Surgery: Decisions Against Life Saving Care - The Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>East Carolina University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: Overall lung surgery rates and black/white disparities have not improved during a&#xD;
      decade of documentation. The goal of this study is to incorporate lessons from the previous&#xD;
      prospective cohort study to optimize lung cancer surgery rates and narrow black-white&#xD;
      disparities for patients diagnosed with stage I or II, non-small cell lung cancer.&#xD;
&#xD;
      Participants: Stage I and II, non-small cell lung cancer at 3 participating sites.&#xD;
      Procedures: Phase I of the study has been completed. Phase I was a deidentified 3-year,&#xD;
      retrospective chart review, used to establish the baseline surgical rates for the&#xD;
      intervention. The patient enrollment phase of the study will move forward that will include&#xD;
      use of a real time registry to follow patient progression through clinical follow up,&#xD;
      diagnostic testing and treatment for biopsy proven or highly probable early stage, non-small&#xD;
      cell lung cancer. The patient enrollment portion of the study will start, September 2012. All&#xD;
      patients with Stage I or II non-small cell lung cancer who enroll in the study will be&#xD;
      entered into real time registries at every site. Patients' progress through the registries&#xD;
      including follow-up provider visits, diagnostic tests, and procedures will be transparent and&#xD;
      any missed appointments will be flagged. Feedback will be given to lung cancer providers in&#xD;
      both arms. The randomized trial will compare patients who receive usual care plus the&#xD;
      registry to those who receive the registry plus visits and calls from a trained cancer&#xD;
      communicator -educator (CCE) who is well versed in issues specific to lung cancer and trained&#xD;
      in active listening and communication that accounts for patients' limitations in health&#xD;
      literacy. The CCE will also use Kleinman's Patient Model to identify attitudes or beliefs&#xD;
      that represent barriers to recommended care that could potentially be addressed through&#xD;
      negotiation and more targeted communication.&#xD;
&#xD;
      The hypothesis is that an electronic warning system, data transparency, and enhanced&#xD;
      communication will optimize lung surgery rates and reduce racial gaps.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Note that the registry intervention will be compared to historical controls obtained from the&#xD;
      electronic chart review. The main outcome will be receipt of lung resection surgery and this&#xD;
      outcome will be assessed controlling for age, race, education, income, perceptions of&#xD;
      communication, co-morbid illnesses, and level of health literacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with stage I and II, non-small cell lung cancer who receive surgery.</measure>
    <time_frame>Baseline to 4 months</time_frame>
    <description>The primary outcome variable, surgery yes or no, will be compared in the control group randomized to usual care, to the intervention group randomized to the cancer communicator.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">238</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Communication Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Specially trained communicator addresses factual understanding and elicits other barriers to care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Real Time Registry and data feedback only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are enrolled in registry and clinicians receive warnings about delayed or missed care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>communication intervention</intervention_name>
    <description>Because of the gaps between documented outcomes of lung cancer surgery and patient communication barriers identified in our recent work, our communication intervention will focus on improving presentation of risk information and confirmation of understanding of patient medical.</description>
    <arm_group_label>Communication Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Real Time Registry and data feedback only</intervention_name>
    <description>This group of patients will not received the enhanced communication intervention</description>
    <arm_group_label>Real Time Registry and data feedback only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 21 years or greater;&#xD;
&#xD;
          2. A probability of 60% or higher of a lung lesion being malignant as calculated by a&#xD;
             Bayesian algorithm using clinical and radiographic characteristics or biopsy proven&#xD;
             disease; and&#xD;
&#xD;
          3. The patient has been clinically classified as having stage I or II disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. incarceration / ward of the state status,&#xD;
&#xD;
          2. Severe cognitive impairment. If a patient meets the inclusion criteria but is&#xD;
             consistently unable to comprehend survey questions during the interview process, we&#xD;
             will exclude that patient from the overall study.&#xD;
&#xD;
          3. absolute contraindications by pulmonary function testing (FEV-1 &lt; 25% of predicted)&#xD;
&#xD;
          4. Non-English speaking. Hispanic patients represent less than 4 percent of lung cancer&#xD;
             patients in North Carolina restricting our ability to document an intervention effect.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel Cykert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of North Carolina, Chapel Hill</investigator_affiliation>
    <investigator_full_name>Samuel Cykert, MD</investigator_full_name>
    <investigator_title>Professor of Medicine and Associate Director, Medical Education</investigator_title>
  </responsible_party>
  <keyword>non small cell lung cancer</keyword>
  <keyword>health disparities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 13, 2011</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT01687738/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 13, 2011</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT01687738/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT01687738
org study id: 11-0992
secondary id: 121218-RSG-05-217-05-CPPB
nct id: NCT01687738
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Purpose: Overall lung surgery rates and black/white disparities have not improved during a
      decade of documentation. The goal of this study is to incorporate lessons from the previous
      prospective cohort study to optimize lung cancer surgery rates and narrow black-white
      disparities for patients diagnosed with stage I or II, non-small cell lung cancer.

      Participants: Stage I and II, non-small cell lung cancer at 3 participating sites.
      Procedures: Phase I of the study has been completed. Phase I was a deidentified 3-year,
      retrospective chart review, used to establish the baseline surgical rates for the
      intervention. The patient enrollment phase of the study will move forward that will include
      use of a real time registry to follow patient progression through clinical follow up,
      diagnostic testing and treatment for biopsy proven or highly probable early stage, non-small
      cell lung cancer. The patient enrollment portion of the study will start, September 2012. All
      patients with Stage I or II non-small cell lung cancer who enroll in the study will be
      entered into real time registries at every site. Patients' progress through the registries
      including follow-up provider visits, diagnostic tests, and procedures will be transparent and
      any missed appointments will be flagged. Feedback will be given to lung cancer providers in
      both arms. The randomized trial will compare patients who receive usual care plus the
      registry to those who receive the registry plus visits and calls from a trained cancer
      communicator -educator (CCE) who is well versed in issues specific to lung cancer and trained
      in active listening and communication that accounts for patients' limitations in health
      literacy. The CCE will also use Kleinman's Patient Model to identify attitudes or beliefs
      that represent barriers to recommended care that could potentially be addressed through
      negotiation and more targeted communication.

      The hypothesis is that an electronic warning system, data transparency, and enhanced
      communication will optimize lung surgery rates and reduce racial gaps.
Note that the registry intervention will be compared to historical controls obtained from the
      electronic chart review. The main outcome will be receipt of lung resection surgery and this
      outcome will be assessed controlling for age, race, education, income, perceptions of
      communication, co-morbid illnesses, and level of health literacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of patients with stage I and II, non-small cell lung cancer who receive surgery.
time frame: Baseline to 4 months
description: The primary outcome variable, surgery yes or no, will be compared in the control group randomized to usual care, to the intervention group randomized to the cancer communicator.
arm group label: Communication Intervention
arm group type: Experimental
description: Specially trained communicator addresses factual understanding and elicits other barriers to care
arm group label: Real Time Registry and data feedback only
arm group type: Experimental
description: Patients are enrolled in registry and clinicians receive warnings about delayed or missed care.
intervention type: Other
intervention name: communication intervention
description: Because of the gaps between documented outcomes of lung cancer surgery and patient communication barriers identified in our recent work, our communication intervention will focus on improving presentation of risk information and confirmation of understanding of patient medical.
arm group label: Communication Intervention
intervention type: Other
intervention name: Real Time Registry and data feedback only
description: This group of patients will not received the enhanced communication intervention
arm group label: Real Time Registry and data feedback only
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel Cykert, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of North Carolina, Chapel Hill
investigator full name: Samuel Cykert, MD
investigator title: Professor of Medicine and Associate Director, Medical Education
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
provided document: 
provided document: 