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/NCT05978128</url>
    </required_header>
    <id_info>
      <org_study_id>22-000947</org_study_id>
      <secondary_id>NCI-2023-04133</secondary_id>
      <nct_id>NCT05978128</nct_id>
    </id_info>
    <brief_title>Utilizing Advocates and Supporters to Increase Lung Cancer Screening Rates in Eligible Participants</brief_title>
    <official_title>Utilizing Spheres of Influence to Increase Cancer Screening: Empowering Community Health Advocates</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jonsson Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jonsson 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial assesses the use of advocates and supporters of breast and lung cancer&#xD;
        screening to increase lung cancer screening rates amongst eligible participants.&#xD;
        Imaging-based cancer screening is utilized with variable frequency. Breast cancer screening&#xD;
        with mammography has been widely accepted and is commonly used among eligible women. Lung&#xD;
        screening with computed tomography scans is poorly used, despite the potential to decrease&#xD;
        deaths from lung cancer. There are many reasons lung screening isn't being used when compared&#xD;
        to breast screening, such as smoking stigma and fear, along with a lack of awareness of lung&#xD;
        screening. By conducting this trial, researchers want to assess the effectiveness of&#xD;
        advocates and supporters of breast and lung screening, and to learn about the psychological&#xD;
        barriers to cancer screening, identifying those that are unique to lung screening.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. Determine the number of patients undergoing breast screening who are eligible to&#xD;
        participate in lung screening.&#xD;
  &#xD;
        II. Determine whether patients currently participating in cancer screening (breast OR lung)&#xD;
        are successful as &quot;cancer screening advocates.&quot; III. Determine whether laypersons who are&#xD;
        aware of screening (including those who accompany friends and family members to their&#xD;
        screening appointments) are successful as &quot;cancer screening advocates.&quot; IV. Identify&#xD;
        knowledge base and psychological barriers to screening through surveys of potential screening&#xD;
        participants.&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Participants access an electronic patient portal with educational materials at baseline, 1-&#xD;
        and 2-year follow-ups, and also interact with a patient navigator on study. Patients also&#xD;
        receive materials to share with their friends/family on benefits of breast and lung cancer&#xD;
        screening on study.&#xD;
  &#xD;
        After completion of study intervention, participants are followed up yearly for up to 3&#xD;
        years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2028</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>Increased rates of lung and breast cancer screening adherence</measure>
      <time_frame>Up to 3 years</time_frame>
      <description>By following up with patients over the defined study period and assessing whether they obtained an incidence screen completed at one-year +/- 3 months from the recommended time. Will also measure the rates of survey completion by consented participants, the number of clicks and time spent reviewing educational materials, and the number of new participants who contacted the program through a referral by another participant.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Success of &quot;sphere of influence&quot; model</measure>
      <time_frame>Up to 3 years</time_frame>
      <description>Considered successful if increased lung cancer screening referrals are a direct result of women receiving screening mammograms inviting and educating friends and family about lung cancer screening.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">800</enrollment>
    <condition>Breast Carcinoma</condition>
    <condition>Lung Carcinoma</condition>
    <arm_group>
      <arm_group_label>Screening (electronic patient portal, patient navigation)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants access an electronic patient portal with educational materials at baseline, 1- and 2-year follow-ups, and also interact with a patient navigator on study. Patients also receive materials to share with their friends/family on benefits of breast and lung cancer screening on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health Education</intervention_name>
      <description>Access electronic patient portal with educational material</description>
      <arm_group_label>Screening (electronic patient portal, patient navigation)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Health Promotion and Education</intervention_name>
      <description>Receive materials on breast/lung cancer screening</description>
      <arm_group_label>Screening (electronic patient portal, patient navigation)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Patient Navigation</intervention_name>
      <description>Interact with a patient navigator</description>
      <arm_group_label>Screening (electronic patient portal, patient navigation)</arm_group_label>
      <other_name>Patient Navigator Program</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Screening (electronic patient portal, patient navigation)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age:&#xD;
  &#xD;
                 -  Breast screening &gt; 40&#xD;
  &#xD;
                 -  Lung screening 50-80&#xD;
  &#xD;
            -  Male (M) or Female (F)&#xD;
  &#xD;
            -  Current, former, or never smokers&#xD;
  &#xD;
            -  Close family or friend with smoking history (in or out of state)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age:&#xD;
  &#xD;
                 -  Breast screening &lt; 40&#xD;
  &#xD;
                 -  Lung screening &lt; 50 or &gt; 80&#xD;
  &#xD;
            -  Persons who had previously received a diagnosis of lung cancer, had hemoptysis, or had&#xD;
               an unexplained weight loss of more than 6.8 kg (15 lb) in the preceding year will also&#xD;
               be excluded&#xD;
  &#xD;
            -  Persons with an active cancer&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ashley E Prosper</last_name>
      <role>Principal Investigator</role>
      <affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>UCLA / Jonsson Comprehensive Cancer Center</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90095</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ashley E. Prosper</last_name>
        <phone>310-825-0958</phone>
        <email>APROSPER@MEDNET.UCLA.EDU</email>
      </contact>
      <investigator>
        <last_name>Ashley E. Prosper</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 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>
      <mesh_term>Breast Neoplasms</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/NCT05978128
  org study id: 22-000947
  secondary id: NCI-2023-04133
  nct id: NCT05978128
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This clinical trial assesses the use of advocates and supporters of breast and lung cancer
        screening to increase lung cancer screening rates amongst eligible participants.
        Imaging-based cancer screening is utilized with variable frequency. Breast cancer screening
        with mammography has been widely accepted and is commonly used among eligible women. Lung
        screening with computed tomography scans is poorly used, despite the potential to decrease
        deaths from lung cancer. There are many reasons lung screening isn't being used when compared
        to breast screening, such as smoking stigma and fear, along with a lack of awareness of lung
        screening. By conducting this trial, researchers want to assess the effectiveness of
        advocates and supporters of breast and lung screening, and to learn about the psychological
        barriers to cancer screening, identifying those that are unique to lung screening.
  PRIMARY OBJECTIVES:
  
        I. Determine the number of patients undergoing breast screening who are eligible to
        participate in lung screening.
  
        II. Determine whether patients currently participating in cancer screening (breast OR lung)
        are successful as "cancer screening advocates." III. Determine whether laypersons who are
        aware of screening (including those who accompany friends and family members to their
        screening appointments) are successful as "cancer screening advocates." IV. Identify
        knowledge base and psychological barriers to screening through surveys of potential screening
        participants.
  
        OUTLINE:
  
        Participants access an electronic patient portal with educational materials at baseline, 1-
        and 2-year follow-ups, and also interact with a patient navigator on study. Patients also
        receive materials to share with their friends/family on benefits of breast and lung cancer
        screening on study.
  
        After completion of study intervention, participants are followed up yearly for up to 3
        years.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Increased rates of lung and breast cancer screening adherence
  time frame: Up to 3 years
  description: By following up with patients over the defined study period and assessing whether they obtained an incidence screen completed at one-year +/- 3 months from the recommended time. Will also measure the rates of survey completion by consented participants, the number of clicks and time spent reviewing educational materials, and the number of new participants who contacted the program through a referral by another participant.
  measure: Success of "sphere of influence" model
  time frame: Up to 3 years
  description: Considered successful if increased lung cancer screening referrals are a direct result of women receiving screening mammograms inviting and educating friends and family about lung cancer screening.
  arm group label: Screening (electronic patient portal, patient navigation)
  arm group type: Experimental
  description: Participants access an electronic patient portal with educational materials at baseline, 1- and 2-year follow-ups, and also interact with a patient navigator on study. Patients also receive materials to share with their friends/family on benefits of breast and lung cancer screening on study.
  intervention type: Behavioral
  intervention name: Health Education
  description: Access electronic patient portal with educational material
  arm group label: Screening (electronic patient portal, patient navigation)
  intervention type: Other
  intervention name: Health Promotion and Education
  description: Receive materials on breast/lung cancer screening
  arm group label: Screening (electronic patient portal, patient navigation)
  intervention type: Behavioral
  intervention name: Patient Navigation
  description: Interact with a patient navigator
  arm group label: Screening (electronic patient portal, patient navigation)
  other name: Patient Navigator Program
  intervention type: Other
  intervention name: Survey Administration
  description: Ancillary studies
  arm group label: Screening (electronic patient portal, patient navigation)
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ashley E Prosper
  role: Principal Investigator
  affiliation: UCLA / Jonsson Comprehensive Cancer Center
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Breast Neoplasms