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/NCT06000683</url>
    </required_header>
    <id_info>
      <org_study_id>IRB#3439</org_study_id>
      <nct_id>NCT06000683</nct_id>
    </id_info>
    <brief_title>Empowering Patients' Lung Cancer Screening Uptake</brief_title>
    <acronym>Empower-LCS</acronym>
    <official_title>Empowering Patients' Lung Cancer Screening Uptake (Empower LCS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Irvine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Irvine</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>
        Lung cancer is the leading cause of cancer related mortality. Lung cancer screening (LCS)&#xD;
        with low dose computed tomography (LDCT) decreases mortality rate of lung cancer by 20%. Yet&#xD;
        many patients who are eligible for lung cancer screening are still falling through the cracks&#xD;
        which prevents patients the ability to detect lung cancer early. This study will test the&#xD;
        effect of a a multi-level intervention on ordering LDCT within 6 months after patient&#xD;
        enrollment. Our proposed intervention includes (1) Primary care provider notifications of&#xD;
        patients' LCS eligibility; (2) patients' education ; (3) patients' referral to financial&#xD;
        navigation resources; and (4) patients' reminder to discuss LCS during PCP visit.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Order of LDCT</measure>
      <time_frame>within 6 months of enrollment</time_frame>
      <description>Primary end point is order of LDCT within 6 months after enrollment assessed with self-reported surveys and EMR data extraction.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Perceived Risk of lung cancer</measure>
      <time_frame>at baseline and 6 month post enrollment</time_frame>
      <description>self reported in survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Severity of lung cancer</measure>
      <time_frame>at baseline and 6 month post enrollment</time_frame>
      <description>self reported in survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Benefit of lung cancer screening</measure>
      <time_frame>at baseline and 6 month post enrollment</time_frame>
      <description>self reported in survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived barriers lung cancer screening</measure>
      <time_frame>at baseline and 6 month post enrollment</time_frame>
      <description>self reported in survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy for lung cancer screening</measure>
      <time_frame>at baseline and 6 month post enrollment</time_frame>
      <description>self reported in survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knowledge about lung cancer and screening</measure>
      <time_frame>at baseline and 6 month post enrollment</time_frame>
      <description>self reported in survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LCS discussion</measure>
      <time_frame>within 6 months after enrollment</time_frame>
      <description>Patient and Primary Care Provider discussing lung cancer screening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Receipt of LDCT</measure>
      <time_frame>Within 6 months of enrollment</time_frame>
      <description>A receipt of LDCT for LCS will be checked either through self reported or EMR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Providers' Perceived barriers</measure>
      <time_frame>within 3 month after last patient enrolled</time_frame>
      <description>Provider will be asked about perceived barriers and knowledge of Lung cancer screening though a survey</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Patient and provider experience with intervention</measure>
      <time_frame>At the end of all study enrollments a subgroup of patients and providers will be interviewed</time_frame>
      <description>Patient and Providers will be asked questions about their experience with intervention components interview</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Empower LCS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patient will be given education material(addressing knowledge barriers); patients' referral to financial navigation resources (addressing health-related social risks); and patients' reminder to discuss LCS during PCP visit. Providers will also be notified of eligibility of their patients to receive LCS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Patient education</intervention_name>
      <description>Patients will be sent information (in preferred language) on lung cancer risk, lung cancer screening (LCS) benefits, harms, false positive rates, recommendations of follow-up for positive results, and exam insurance coverage.</description>
      <arm_group_label>Empower LCS</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Referral to financial navigation resources</intervention_name>
      <description>Patients who self-report needing help with health-related social risks at baseline will be sent a brochure (in preferred language) from patient advocate foundation (PAF), a national non-profit financial navigation organization, where patients can self-refer.</description>
      <arm_group_label>Empower LCS</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Patient Reminders</intervention_name>
      <description>Within 2 weeks prior to primary care appointment, patients will receive a text message or a phone call (if not having a phone that receives text messaging) encouraging patients to discuss the LCS with their provider.</description>
      <arm_group_label>Empower LCS</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Provider Reminers</intervention_name>
      <description>Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for LCS.</description>
      <arm_group_label>Empower LCS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged 50- 80 years of age.&#xD;
  &#xD;
            2. Be able to Speak English, Spanish, or Vietnamese&#xD;
  &#xD;
            3. Must have a scheduled appointment with their Primary Care Providers with in next one&#xD;
               to three months.&#xD;
  &#xD;
            4. The Scheduled PCP appointment is at any of the UCI Health primary care clinics in&#xD;
               Orange County including two UCI federally qualified health centers&#xD;
  &#xD;
            5. History of 20 pack year smoking history ( based on survey self report)&#xD;
  &#xD;
            6. Current smoker or a former smoker who has quit smoking within the last 15 years (based&#xD;
               on survey self report)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1 No prior history of lung cancer 2, No chest CT for any reason in the last 12 months based&#xD;
          on self-report and UCI EMR 3,No history of Alzheimer's disease or dementia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gelareh Sadigh, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, Irvine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gelareh Sadigh, MD</last_name>
      <phone>949-745-5066</phone>
      <email>gsadigh@uci.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Desiree Caballero, MS</last_name>
      <phone>949-745-5066</phone>
      <email>dncaball@uci.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Irvine</investigator_affiliation>
      <investigator_full_name>Gelareh Sadigh</investigator_full_name>
      <investigator_title>Associate Professor In Residence</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06000683
  org study id: IRB#3439
  nct id: NCT06000683
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Lung cancer is the leading cause of cancer related mortality. Lung cancer screening (LCS)
        with low dose computed tomography (LDCT) decreases mortality rate of lung cancer by 20%. Yet
        many patients who are eligible for lung cancer screening are still falling through the cracks
        which prevents patients the ability to detect lung cancer early. This study will test the
        effect of a a multi-level intervention on ordering LDCT within 6 months after patient
        enrollment. Our proposed intervention includes (1) Primary care provider notifications of
        patients' LCS eligibility; (2) patients' education ; (3) patients' referral to financial
        navigation resources; and (4) patients' reminder to discuss LCS during PCP visit.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Order of LDCT
  time frame: within 6 months of enrollment
  description: Primary end point is order of LDCT within 6 months after enrollment assessed with self-reported surveys and EMR data extraction.
  measure: Perceived Risk of lung cancer
  time frame: at baseline and 6 month post enrollment
  description: self reported in survey
  measure: Perceived Severity of lung cancer
  time frame: at baseline and 6 month post enrollment
  description: self reported in survey
  measure: Perceived Benefit of lung cancer screening
  time frame: at baseline and 6 month post enrollment
  description: self reported in survey
  measure: Perceived barriers lung cancer screening
  time frame: at baseline and 6 month post enrollment
  description: self reported in survey
  measure: Self-efficacy for lung cancer screening
  time frame: at baseline and 6 month post enrollment
  description: self reported in survey
  measure: Knowledge about lung cancer and screening
  time frame: at baseline and 6 month post enrollment
  description: self reported in survey
  measure: LCS discussion
  time frame: within 6 months after enrollment
  description: Patient and Primary Care Provider discussing lung cancer screening
  measure: Receipt of LDCT
  time frame: Within 6 months of enrollment
  description: A receipt of LDCT for LCS will be checked either through self reported or EMR
  measure: Providers' Perceived barriers
  time frame: within 3 month after last patient enrolled
  description: Provider will be asked about perceived barriers and knowledge of Lung cancer screening though a survey
  measure: Patient and provider experience with intervention
  time frame: At the end of all study enrollments a subgroup of patients and providers will be interviewed
  description: Patient and Providers will be asked questions about their experience with intervention components interview
  arm group label: Empower LCS
  arm group type: Experimental
  description: Patient will be given education material(addressing knowledge barriers); patients' referral to financial navigation resources (addressing health-related social risks); and patients' reminder to discuss LCS during PCP visit. Providers will also be notified of eligibility of their patients to receive LCS.
  intervention type: Behavioral
  intervention name: Patient education
  description: Patients will be sent information (in preferred language) on lung cancer risk, lung cancer screening (LCS) benefits, harms, false positive rates, recommendations of follow-up for positive results, and exam insurance coverage.
  arm group label: Empower LCS
  intervention type: Behavioral
  intervention name: Referral to financial navigation resources
  description: Patients who self-report needing help with health-related social risks at baseline will be sent a brochure (in preferred language) from patient advocate foundation (PAF), a national non-profit financial navigation organization, where patients can self-refer.
  arm group label: Empower LCS
  intervention type: Behavioral
  intervention name: Patient Reminders
  description: Within 2 weeks prior to primary care appointment, patients will receive a text message or a phone call (if not having a phone that receives text messaging) encouraging patients to discuss the LCS with their provider.
  arm group label: Empower LCS
  intervention type: Behavioral
  intervention name: Provider Reminers
  description: Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for LCS.
  arm group label: Empower LCS
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Gelareh Sadigh, MD
  role: Principal Investigator
  affiliation: University of California, Irvine
  last name: Gelareh Sadigh, MD
  phone: 949-745-5066
  email: gsadigh@uci.edu
  last name: Desiree Caballero, MS
  phone: 949-745-5066
  email: dncaball@uci.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Irvine
  investigator full name: Gelareh Sadigh
  investigator title: Associate Professor In Residence
  mesh term: Lung Neoplasms
  sharing ipd: No