<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/NCT04432753</url>
  </required_header>
  <id_info>
    <org_study_id>19-2709</org_study_id>
    <nct_id>NCT04432753</nct_id>
  </id_info>
  <brief_title>Effect of Incidental Findings Information on Lung Cancer Screening Intent</brief_title>
  <official_title>Effect of Incidental Findings Information on Lung Cancer Screening Intent: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UNC Cecil G. Sheps Center for Health Services Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</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>
      This online randomized controlled trial seeks to determine if inclusion of incidental&#xD;
      findings information in a lung cancer screening decision aid affects screening intent among&#xD;
      screening-eligible individuals. Participants will view either a decision aid with incidental&#xD;
      findings information or without and indicate their intent to pursue lung cancer screening.&#xD;
&#xD;
      Hypothesis: Inclusion of incidental findings in a decision aid will decrease intent to screen&#xD;
      among participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">August 22, 2020</completion_date>
  <primary_completion_date type="Actual">August 22, 2020</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>Screening</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of individuals who plan to pursue lung cancer screening</measure>
    <time_frame>Day 1</time_frame>
    <description>This will be assessed by a survey item where participants indicate their response to a statement of whether they plan to pursue lung cancer screening, with answer choices being strongly agree, agree, disagree and strongly disagree. Comparison between the intervention and control groups will be made.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean score on scale of lung cancer screening knowledge</measure>
    <time_frame>Day 1</time_frame>
    <description>Lung cancer screening knowledge tested by 6 multiple choice questions on facts of the benefit and harms of screening. The questions will be answered before and after participants watch a lung cancer screening decision aid. Scores will be determined by the number of correct answers for questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean rating of benefit and harms of screening</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants will rate (Likert 1-5 scale with 1 being less important and 5 being more important) 6 lung cancer screening benefits and harms on importance to them.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time Lung Cancer Screening Benefit and Harms are ranked first and last</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants will rank six lung cancer screening benefits and harms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean ranking of benefit and harms of screening</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants will rank six lung cancer screening benefits and harms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time each lung cancer screening harm is ranked highest of the five potential harms</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants will rank six lung cancer screening benefits and harms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean ranking of incidental findings attribute</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants will rank six lung cancer screening benefits and harms, including one on incidental findings. Comparison of mean ranking will be made between the intervention and control groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">419</enrollment>
  <condition>Neoplasm of Lung</condition>
  <condition>Decision Support Techniques</condition>
  <condition>Mass Screening</condition>
  <arm_group>
    <arm_group_label>Decision aid with incidental findings information</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will view a video decision aid that include information on incidental findings in lung cancer screening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decision aid without incidental findings information</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will view a video decision aid that does not include information on incidental findings in lung cancer screening.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lung Cancer Screening Decision Aid with Incidental Findings Information</intervention_name>
    <description>The intervention consists of a previously tested and developed brief lung cancer screening video decision aid with the addition of information on incidental findings for lung cancer screening.</description>
    <arm_group_label>Decision aid with incidental findings information</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lung Cancer Screening Decision Aid without Incidental Findings Information</intervention_name>
    <description>The intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings.</description>
    <arm_group_label>Decision aid without incidental findings information</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  55-80 year old male or female&#xD;
&#xD;
          -  Current or former smoker who quit within the last 15 years&#xD;
&#xD;
          -  At least 30 pack years of smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Clark, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Jonas, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>December 8, 2020</last_update_submitted>
  <last_update_submitted_qc>December 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Incidental Findings</keyword>
  <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/NCT04432753
org study id: 19-2709
nct id: NCT04432753
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This online randomized controlled trial seeks to determine if inclusion of incidental
      findings information in a lung cancer screening decision aid affects screening intent among
      screening-eligible individuals. Participants will view either a decision aid with incidental
      findings information or without and indicate their intent to pursue lung cancer screening.

      Hypothesis: Inclusion of incidental findings in a decision aid will decrease intent to screen
      among participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Investigator)
measure: Percentage of individuals who plan to pursue lung cancer screening
time frame: Day 1
description: This will be assessed by a survey item where participants indicate their response to a statement of whether they plan to pursue lung cancer screening, with answer choices being strongly agree, agree, disagree and strongly disagree. Comparison between the intervention and control groups will be made.
measure: Mean score on scale of lung cancer screening knowledge
time frame: Day 1
description: Lung cancer screening knowledge tested by 6 multiple choice questions on facts of the benefit and harms of screening. The questions will be answered before and after participants watch a lung cancer screening decision aid. Scores will be determined by the number of correct answers for questions.
measure: Mean rating of benefit and harms of screening
time frame: Day 1
description: Participants will rate (Likert 1-5 scale with 1 being less important and 5 being more important) 6 lung cancer screening benefits and harms on importance to them.
measure: Percentage of Time Lung Cancer Screening Benefit and Harms are ranked first and last
time frame: Day 1
description: Participants will rank six lung cancer screening benefits and harms.
measure: Mean ranking of benefit and harms of screening
time frame: Day 1
description: Participants will rank six lung cancer screening benefits and harms.
measure: Percentage of time each lung cancer screening harm is ranked highest of the five potential harms
time frame: Day 1
description: Participants will rank six lung cancer screening benefits and harms.
measure: Mean ranking of incidental findings attribute
time frame: Day 1
description: Participants will rank six lung cancer screening benefits and harms, including one on incidental findings. Comparison of mean ranking will be made between the intervention and control groups.
arm group label: Decision aid with incidental findings information
arm group type: Experimental
description: Participants in this arm will view a video decision aid that include information on incidental findings in lung cancer screening.
arm group label: Decision aid without incidental findings information
arm group type: Active Comparator
description: Participants in this arm will view a video decision aid that does not include information on incidental findings in lung cancer screening.
intervention type: Behavioral
intervention name: Lung Cancer Screening Decision Aid with Incidental Findings Information
description: The intervention consists of a previously tested and developed brief lung cancer screening video decision aid with the addition of information on incidental findings for lung cancer screening.
arm group label: Decision aid with incidental findings information
intervention type: Behavioral
intervention name: Lung Cancer Screening Decision Aid without Incidental Findings Information
description: The intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings.
arm group label: Decision aid without incidental findings information
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Clark, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Daniel Jonas, MD, MPH
role: Study Director
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms