<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/NCT03820557</url>
  </required_header>
  <id_info>
    <org_study_id>17G.352</org_study_id>
    <nct_id>NCT03820557</nct_id>
  </id_info>
  <brief_title>Decision Counseling Program in Increasing Shared Decision Making and Clinical Trial Participation in Patients With Stage 0-IV Lung Cancer (Free to Breathe)</brief_title>
  <official_title>Increasing Shared Decision Making and Patient Participation in Lung Cancer Clinical Trials (Free to Breathe)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This clinical trial studies how well the Decision Counseling Program works in increasing&#xD;
      patient-physician shared decision making and participation in clinical trials for lung cancer&#xD;
      patients. Decision aids help provide patients with information that may help them select a&#xD;
      course of action related to their cancer care when more than one alternative is available. It&#xD;
      also encourages shared decision making allowing patients and their providers to make health&#xD;
      decisions together. Determining how patients make decisions about participating in a clinical&#xD;
      trial may help doctors facilitate patient decision making and improve participation in lung&#xD;
      cancer clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Facilitate patient deliberation about participation in a lung cancer clinical trial using&#xD;
      the Decision Counseling Program (DCP).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Document the extent to which patient values and preferences are incorporated into&#xD;
      physician-patient shared decision making (SDM) about cancer clinical trials.&#xD;
&#xD;
      II. Assess changes in patient knowledge, anxiety, and decisional conflict related to clinical&#xD;
      trial participation.&#xD;
&#xD;
      III. Characterize patient and physician experience with intervention exposure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2017</start_date>
  <completion_date type="Actual">March 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient perception related to clinical trials participation, measured by follow up survey questions</measure>
    <time_frame>Baseline to 30 days</time_frame>
    <description>Will compute descriptive statistics for all sections and determine the variables on which to compare patient responses at the two time points (baseline and endpoint) using paired t-tests.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Decision Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo participation in the DCP prior to an audio-recorded oncology appointment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Undergo Decision Counseling Program</description>
    <arm_group_label>Decision Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with lung cancer (Stages 0, 1, 2, 3, 4)&#xD;
&#xD;
          -  Lung cancer patients for which there is an available interventional clinical trial&#xD;
             open at Jefferson Kimmel Cancer Center&#xD;
&#xD;
          -  Patients being treated by a lung medical oncologist on the Center City Campus of&#xD;
             Thomas Jefferson University&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to communicate in English&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Not eligible for an open, actively accruing interventional trial at Jefferson&#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>Amy Leader, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sidney Kimmel Cancer Center at Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sidney Kimmel Cancer Center at Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT03820557
org study id: 17G.352
nct id: NCT03820557
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This clinical trial studies how well the Decision Counseling Program works in increasing
      patient-physician shared decision making and participation in clinical trials for lung cancer
      patients. Decision aids help provide patients with information that may help them select a
      course of action related to their cancer care when more than one alternative is available. It
      also encourages shared decision making allowing patients and their providers to make health
      decisions together. Determining how patients make decisions about participating in a clinical
      trial may help doctors facilitate patient decision making and improve participation in lung
      cancer clinical trials.
PRIMARY OBJECTIVES:

      I. Facilitate patient deliberation about participation in a lung cancer clinical trial using
      the Decision Counseling Program (DCP).

      SECONDARY OBJECTIVES:

      I. Document the extent to which patient values and preferences are incorporated into
      physician-patient shared decision making (SDM) about cancer clinical trials.

      II. Assess changes in patient knowledge, anxiety, and decisional conflict related to clinical
      trial participation.

      III. Characterize patient and physician experience with intervention exposure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patient perception related to clinical trials participation, measured by follow up survey questions
time frame: Baseline to 30 days
description: Will compute descriptive statistics for all sections and determine the variables on which to compare patient responses at the two time points (baseline and endpoint) using paired t-tests.
arm group label: Decision Counseling
arm group type: Experimental
description: Patients undergo participation in the DCP prior to an audio-recorded oncology appointment.
intervention type: Other
intervention name: Educational Intervention
description: Undergo Decision Counseling Program
arm group label: Decision Counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amy Leader, DrPH
role: Principal Investigator
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
facility: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Lung Neoplasms