xml: <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/NCT06010355</url>
    </required_header>
    <id_info>
      <org_study_id>iRISID-2022-1320</org_study_id>
      <nct_id>NCT06010355</nct_id>
    </id_info>
    <brief_title>Culturally Tailored Educational Video to Promote Lung Cancer Screening in Vulnerable Communities</brief_title>
    <official_title>Breathe Easier, Philadelphia! Engaging Vulnerable Communities for Innovative Lung Cancer Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Thomas Jefferson University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Thomas Jefferson University</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 clinical trial evaluates the impact of a culturally tailored educational video on the&#xD;
        perceptions of lung cancer and lung cancer screening in vulnerable communities. Lung cancer&#xD;
        is the most common cancer type. African-American communities have a higher rate than any&#xD;
        other racial or ethnic group in the United States and accounts for the highest number of&#xD;
        deaths among African-Americans. Lung cancer is in the top three causes of cancer death among&#xD;
        Asian men and women. Research has shown that low-income, minority and immigrant individuals&#xD;
        may be under resourced to make decisions about prevention programs and early detection&#xD;
        measures for lung cancer. A culturally tailored educational video may be an effective method&#xD;
        to help people learn about lung cancer, susceptibility toward lung cancer and lung cancer&#xD;
        screening. This may increase lung cancer screening in vulnerable communities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. To understand barriers and opportunities for engaging three culturally distinct&#xD;
        populations in lung cancer screening.&#xD;
  &#xD;
        II. To develop three culturally tailored educational videos about lung cancer and the&#xD;
        benefits of lung cancer screening.&#xD;
  &#xD;
        III. To test the impact of the videos on susceptibility to lung cancer, knowledge of lung&#xD;
        cancer screening, and intentions to undergo lung cancer screening in a diverse sample of&#xD;
        at-risk individuals.&#xD;
  &#xD;
        OUTLINE: Participants are assigned to 1 of 3 arms.&#xD;
  &#xD;
        ARM I (AIM 1): Participants participate in a focus group over 1 hour in support of the&#xD;
        development of a culturally tailored educational video on study.&#xD;
  &#xD;
        ARM II (AIM 2): Participants watch a culturally tailored educational video over 3-5 minutes&#xD;
        and then immediately undergo an interview in support of the refinement of a culturally&#xD;
        tailored educational video on study.&#xD;
  &#xD;
        ARM III (AIM 3): Participants watch a culturally tailored educational video over 3-5 minutes&#xD;
        and complete a brief test pre- and post-video over 30 minutes on study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in knowledge about lung cancer screening</measure>
      <time_frame>From baseline to endpoint, up to 1 year</time_frame>
      <description>McNemar's test and 95% confidence intervals (CI) used to compare the post-video knowledge response (single multiple choice correct/incorrect item) to the pre-video baseline knowledge response. Generalized estimating equations (GEE) linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in perceptions of susceptibility to lung cancer</measure>
      <time_frame>From baseline to endpoint, up to 1 year</time_frame>
      <description>Paired t-tests and 95% CI used to compare the post-video perceived susceptibility scores (scored from four 4-point Likert scaled items to pre-video baseline scores. GEE linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in intention to undergo lung cancer screening</measure>
      <time_frame>From baseline to endpoint, up to 1 year</time_frame>
      <description>Paired t-tests and 95% CI used to compare the post-video intention to screen score (single 4-point Likert scaled item) to pre-video baseline scores. GEE linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Cigarette Smoking-Related Carcinoma</condition>
    <condition>Lung Carcinoma</condition>
    <arm_group>
      <arm_group_label>Arm I (Aim 1) (focus group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants participate in a focus group over 1 hour in support of the development of a culturally tailored educational video on study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm II (Aim 2) (video, interview)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants watch a culturally tailored educational video over 3-5 minutes and then immediately undergo an interview in support of the refinement of a culturally tailored educational video on study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm III (Aim 3) (video, test)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants watch a culturally tailored educational video over 3-5 minutes and complete a brief test pre- and post-video over 30 minutes on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Discussion</intervention_name>
      <description>Participate in focus groups</description>
      <arm_group_label>Arm I (Aim 1) (focus group)</arm_group_label>
      <other_name>Discuss</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Media Intervention</intervention_name>
      <description>Watch culturally appropriate video</description>
      <arm_group_label>Arm II (Aim 2) (video, interview)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interview</intervention_name>
      <description>Undergo interview</description>
      <arm_group_label>Arm II (Aim 2) (video, interview)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Media Intervention</intervention_name>
      <description>Watch culturally appropriate video</description>
      <arm_group_label>Arm III (Aim 3) (video, test)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Test</intervention_name>
      <description>Complete test</description>
      <arm_group_label>Arm III (Aim 3) (video, test)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  AIM 1: Participants must be African American, Korean, or Chinese adults who have&#xD;
               either: a history of smoking, a history of lung cancer, or who have undergone lung&#xD;
               cancer screening&#xD;
  &#xD;
            -  AIM 2: Participants must be African American, Korean, or Chinese adults who have&#xD;
               either: a history of smoking, a history of lung cancer, or who have undergone lung&#xD;
               cancer screening&#xD;
  &#xD;
            -  AIM 3: Those who are African American, Korean or Chinese, and are eligible for lung&#xD;
               cancer screening, based on current screening guidelines: Current or former smokers who&#xD;
               are between 50 and 80 years of age and who have smoked at least one pack a day for 20&#xD;
               years or two packs a day for 10 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  AIM 1: Those excluded from participating include children; those who are not members&#xD;
               of the African American, Chinese, or Korean community; those who do not have one of&#xD;
               the following: a history of smoking, a history of lung cancer, or have undergone lung&#xD;
               cancer screening&#xD;
  &#xD;
            -  AIM 2: Those excluded from participating include children; those who are not members&#xD;
               of the African American, Chinese, or Korean community; those who do not have one of&#xD;
               the following: a history of smoking, a history of lung cancer, or have undergone lung&#xD;
               cancer screening&#xD;
  &#xD;
            -  AIM 3: Those excluded from participating include children; those who are not members&#xD;
               of the African American, Chinese, or Korean community; those who do not have a history&#xD;
               of smoking; those who have been diagnosed with lung cancer; those who have undergone&#xD;
               lung cancer screening in the past&#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 R Leader, DrPH, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Thomas Jefferson University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amy Leader, DrPH, MPH</last_name>
      <phone>215-955-7739</phone>
      <email>Amy.Leader@jefferson.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Thomas Jefferson University Hospital</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amy Leader, DrPH, MPH</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</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>Carcinoma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010355
  org study id: iRISID-2022-1320
  nct id: NCT06010355
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial evaluates the impact of a culturally tailored educational video on the
        perceptions of lung cancer and lung cancer screening in vulnerable communities. Lung cancer
        is the most common cancer type. African-American communities have a higher rate than any
        other racial or ethnic group in the United States and accounts for the highest number of
        deaths among African-Americans. Lung cancer is in the top three causes of cancer death among
        Asian men and women. Research has shown that low-income, minority and immigrant individuals
        may be under resourced to make decisions about prevention programs and early detection
        measures for lung cancer. A culturally tailored educational video may be an effective method
        to help people learn about lung cancer, susceptibility toward lung cancer and lung cancer
        screening. This may increase lung cancer screening in vulnerable communities.
  PRIMARY OBJECTIVES:
  
        I. To understand barriers and opportunities for engaging three culturally distinct
        populations in lung cancer screening.
  
        II. To develop three culturally tailored educational videos about lung cancer and the
        benefits of lung cancer screening.
  
        III. To test the impact of the videos on susceptibility to lung cancer, knowledge of lung
        cancer screening, and intentions to undergo lung cancer screening in a diverse sample of
        at-risk individuals.
  
        OUTLINE: Participants are assigned to 1 of 3 arms.
  
        ARM I (AIM 1): Participants participate in a focus group over 1 hour in support of the
        development of a culturally tailored educational video on study.
  
        ARM II (AIM 2): Participants watch a culturally tailored educational video over 3-5 minutes
        and then immediately undergo an interview in support of the refinement of a culturally
        tailored educational video on study.
  
        ARM III (AIM 3): Participants watch a culturally tailored educational video over 3-5 minutes
        and complete a brief test pre- and post-video over 30 minutes on study.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Change in knowledge about lung cancer screening
  time frame: From baseline to endpoint, up to 1 year
  description: McNemar's test and 95% confidence intervals (CI) used to compare the post-video knowledge response (single multiple choice correct/incorrect item) to the pre-video baseline knowledge response. Generalized estimating equations (GEE) linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.
  measure: Change in perceptions of susceptibility to lung cancer
  time frame: From baseline to endpoint, up to 1 year
  description: Paired t-tests and 95% CI used to compare the post-video perceived susceptibility scores (scored from four 4-point Likert scaled items to pre-video baseline scores. GEE linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.
  measure: Change in intention to undergo lung cancer screening
  time frame: From baseline to endpoint, up to 1 year
  description: Paired t-tests and 95% CI used to compare the post-video intention to screen score (single 4-point Likert scaled item) to pre-video baseline scores. GEE linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.
  arm group label: Arm I (Aim 1) (focus group)
  arm group type: Experimental
  description: Participants participate in a focus group over 1 hour in support of the development of a culturally tailored educational video on study.
  arm group label: Arm II (Aim 2) (video, interview)
  arm group type: Experimental
  description: Participants watch a culturally tailored educational video over 3-5 minutes and then immediately undergo an interview in support of the refinement of a culturally tailored educational video on study.
  arm group label: Arm III (Aim 3) (video, test)
  arm group type: Experimental
  description: Participants watch a culturally tailored educational video over 3-5 minutes and complete a brief test pre- and post-video over 30 minutes on study.
  intervention type: Procedure
  intervention name: Discussion
  description: Participate in focus groups
  arm group label: Arm I (Aim 1) (focus group)
  other name: Discuss
  intervention type: Other
  intervention name: Media Intervention
  description: Watch culturally appropriate video
  arm group label: Arm II (Aim 2) (video, interview)
  intervention type: Other
  intervention name: Interview
  description: Undergo interview
  arm group label: Arm II (Aim 2) (video, interview)
  intervention type: Other
  intervention name: Media Intervention
  description: Watch culturally appropriate video
  arm group label: Arm III (Aim 3) (video, test)
  intervention type: Other
  intervention name: Test
  description: Complete test
  arm group label: Arm III (Aim 3) (video, test)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amy R Leader, DrPH, MPH
  role: Principal Investigator
  affiliation: Thomas Jefferson University
  last name: Amy Leader, DrPH, MPH
  phone: 215-955-7739
  email: Amy.Leader@jefferson.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Carcinoma