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/NCT05980182</url>
    </required_header>
    <id_info>
      <org_study_id>MCC-21-18632</org_study_id>
      <secondary_id>HM20023619</secondary_id>
      <secondary_id>CA264067-01</secondary_id>
      <nct_id>NCT05980182</nct_id>
    </id_info>
    <brief_title>Engaging Black Men in Colorectal Cancer Screening</brief_title>
    <acronym>SUCCEED</acronym>
    <official_title>SUCCEED: Engaging Black Men in Colorectal Cancer Screening (CRC) Screening</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Virginia Commonwealth University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Virginia Commonwealth 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>
        To determine the unmet needs, attitudes, barriers and facilitators of African American (AA)/&#xD;
        Black men use of colorectal cancer screening and describe how community leaders such as&#xD;
        barbers may act as Community Champions to educate and facilitate screening participation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 5, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Colorectal Screening Status</measure>
      <time_frame>3 Months</time_frame>
      <description>The number of participants that complete screening (any type)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determine feasibility of Mobile Health (mHealth) Application -Enrollment</measure>
      <time_frame>Week 1</time_frame>
      <description>The number of men that enroll for the intervention (application)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine the feasibility of the mHealth Application-Videos</measure>
      <time_frame>Week 1</time_frame>
      <description>The number of participants that view the videos</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine the feasibility of the mHealth Application- Retention</measure>
      <time_frame>Baseline (Day 1), Week 2, and Week 12</time_frame>
      <description>The number of participants that complete Questionnaires (&gt;75%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine the feasibility of the mHealth Application- Clinic/ Screening Request</measure>
      <time_frame>Week 12</time_frame>
      <description>The number of participants that respond to the request to contact clinic/ navigation services</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine the feasibility of the mHealth Application - Sharing Content</measure>
      <time_frame>Week 12</time_frame>
      <description>The number of participants that share content on social network</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Colorectal Cancer</condition>
    <condition>CRC</condition>
    <condition>Behavior</condition>
    <arm_group>
      <arm_group_label>Tailored Screen to Save (S2S) content</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Content to be delivered using a combination of short video and text-based information optimized for delivery via Quick Response (QR) codes for smartphones.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>mHealth Application</intervention_name>
      <description>Self-directed application (app) that is downloaded to the participant's personal device. The app contains five informational videos, that provide an orientation to the content on the app, and discuss what colorectal cancer is, and the type of CRC screening tests that are available as well as a video with a personal history. There is a a National Cancer Institute (NCI) risk calculation tool, and a family history infographic. Once the videos have been viewed participants have the option to indicate if they wish to receive a call from the healthcare clinic to discuss scheduling an appointment for screening.</description>
      <arm_group_label>Tailored Screen to Save (S2S) content</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult men&#xD;
  &#xD;
            -  Identify as Black or African American&#xD;
  &#xD;
            -  Work or live in Petersburg, VA or surrounding counties&#xD;
  &#xD;
            -  Eligible for colorectal cancer (CRC) screening at time of study enrollment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to speak or read English&#xD;
  &#xD;
            -  Currently up-to-date with CRC screening&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>74 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maria Thomson, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Virginia Commonwealt University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maria Thomson, Ph.D.</last_name>
      <phone>804-628-2640</phone>
      <email>mthomson2@vcu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Virginia Commonwealth University</name>
        <address>
          <city>Richmond</city>
          <state>Virginia</state>
          <zip>23298</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maria Thomson, Ph.D.</last_name>
        <phone>804-628-2640</phone>
        <email>mthomson2@vcu.edu</email>
      </contact>
      <investigator>
        <last_name>Maria Thomson, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Colorectal Screening behaviors</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</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/NCT05980182
  org study id: MCC-21-18632
  secondary id: HM20023619
  secondary id: CA264067-01
  nct id: NCT05980182
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To determine the unmet needs, attitudes, barriers and facilitators of African American (AA)/
        Black men use of colorectal cancer screening and describe how community leaders such as
        barbers may act as Community Champions to educate and facilitate screening participation.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Colorectal Screening Status
  time frame: 3 Months
  description: The number of participants that complete screening (any type)
  measure: Determine feasibility of Mobile Health (mHealth) Application -Enrollment
  time frame: Week 1
  description: The number of men that enroll for the intervention (application)
  measure: Determine the feasibility of the mHealth Application-Videos
  time frame: Week 1
  description: The number of participants that view the videos
  measure: Determine the feasibility of the mHealth Application- Retention
  time frame: Baseline (Day 1), Week 2, and Week 12
  description: The number of participants that complete Questionnaires (>75%)
  measure: Determine the feasibility of the mHealth Application- Clinic/ Screening Request
  time frame: Week 12
  description: The number of participants that respond to the request to contact clinic/ navigation services
  measure: Determine the feasibility of the mHealth Application - Sharing Content
  time frame: Week 12
  description: The number of participants that share content on social network
  arm group label: Tailored Screen to Save (S2S) content
  arm group type: Experimental
  description: Content to be delivered using a combination of short video and text-based information optimized for delivery via Quick Response (QR) codes for smartphones.
  intervention type: Behavioral
  intervention name: mHealth Application
  description: Self-directed application (app) that is downloaded to the participant's personal device. The app contains five informational videos, that provide an orientation to the content on the app, and discuss what colorectal cancer is, and the type of CRC screening tests that are available as well as a video with a personal history. There is a a National Cancer Institute (NCI) risk calculation tool, and a family history infographic. Once the videos have been viewed participants have the option to indicate if they wish to receive a call from the healthcare clinic to discuss scheduling an appointment for screening.
  arm group label: Tailored Screen to Save (S2S) content
  criteria: 
  gender: Male
  minimum age: 45 Years
  maximum age: 74 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maria Thomson, Ph.D.
  role: Principal Investigator
  affiliation: Virginia Commonwealt University
  last name: Maria Thomson, Ph.D.
  phone: 804-628-2640
  email: mthomson2@vcu.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  sharing ipd: Yes