<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/NCT04478110</url>
  </required_header>
  <id_info>
    <org_study_id>Korean CRC</org_study_id>
    <secondary_id>U54CA153513</secondary_id>
    <nct_id>NCT04478110</nct_id>
  </id_info>
  <brief_title>Korean CRC Screening Study PT13599</brief_title>
  <official_title>Community-Based Participatory Intervention to Improve Colorectal Cancer Screening Among Under-Served Korean Americans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Korean Americans report the lowest and declined rates of colorectal cancer (CRC) screening,&#xD;
      compared to general population in the United States. The present study aimed to evaluate the&#xD;
      efficacy of a community-based multifaceted intervention designed to improve CRC screening&#xD;
      among Korean Americans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2010</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CRC screening rates</measure>
    <time_frame>12 months</time_frame>
    <description>the completion of either FIT kit, sigmoidoscopy, or colonoscopy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">925</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Interactive education with linkage to care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Main intervention components included interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>general health education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receive a group education session focused on general health education and primary prevention issues.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care.</intervention_name>
    <description>The interactive group education was aimed to increase participant overall understanding of CRC, screening methods, and utilization of available resources such as home test kit and navigation services, with the ultimate goal of increasing screening rates. Clinical partners provided clinical support and ensured successful screening assessment and follow-ups by offering more flexible hours of clinic operation with bilingual medical staff on site. Patient navigation assistance was also offered based on participants' needs. The range of assistance included scheduling appointments with clinical partners for sigmoidoscopy/colonoscopy for screening and diagnosis after a FIT positive result, assisting paper.</description>
    <arm_group_label>Interactive education with linkage to care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education Session on General Health</intervention_name>
    <description>Participants in the control group received a group education session in a similar format with that of the intervention group delivered by trained Korean community health educators. Different from the intervention group, the education focused on general health education and primary prevention issues, including routine health examinations and screening for various diseases such as cancer. Korean version of work and communication with a physician, and arranging transportation. standard printed materials and guidelines related to the education contents were also provided, including CRC screening guidelines.</description>
    <arm_group_label>general health education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants were eligible to participate in this study if they:&#xD;
&#xD;
               1. were self-identified Korean Americans;&#xD;
&#xD;
               2. were 50 years and older;&#xD;
&#xD;
               3. did not have a colorectal polyp, CRC cancer, or a family history of CRC (first&#xD;
                  degree relative); and&#xD;
&#xD;
               4. non-adherent to CRC screening guidelines (never had any CRC screening or were&#xD;
                  overdue for screening).&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grace X Ma, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Asian Health, Lewis Katz School of Medicine, Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6746426/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Ma GX, Lee M, Beeber M, Das R, Feng Z, Wang MQ, Tan Y, Zhu L, Navder K, Shireman TI, Siu P, Rhee J, Nguyen MT. Community-Clinical Linkage Intervention to Improve Colorectal Cancer Screening Among Underserved Korean Americans. Cancer Health Disparities. 2019;3:e1-e15. Epub 2019 Aug 19.</citation>
    <PMID>31528846</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 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>Colorectal 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/NCT04478110
org study id: Korean CRC
secondary id: U54CA153513
nct id: NCT04478110
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Korean Americans report the lowest and declined rates of colorectal cancer (CRC) screening,
      compared to general population in the United States. The present study aimed to evaluate the
      efficacy of a community-based multifaceted intervention designed to improve CRC screening
      among Korean Americans.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Care Provider)
measure: CRC screening rates
time frame: 12 months
description: the completion of either FIT kit, sigmoidoscopy, or colonoscopy
arm group label: Interactive education with linkage to care
arm group type: Experimental
description: Main intervention components included interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care
arm group label: general health education
arm group type: Active Comparator
description: Receive a group education session focused on general health education and primary prevention issues.
intervention type: Behavioral
intervention name: interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care.
description: The interactive group education was aimed to increase participant overall understanding of CRC, screening methods, and utilization of available resources such as home test kit and navigation services, with the ultimate goal of increasing screening rates. Clinical partners provided clinical support and ensured successful screening assessment and follow-ups by offering more flexible hours of clinic operation with bilingual medical staff on site. Patient navigation assistance was also offered based on participants' needs. The range of assistance included scheduling appointments with clinical partners for sigmoidoscopy/colonoscopy for screening and diagnosis after a FIT positive result, assisting paper.
arm group label: Interactive education with linkage to care
intervention type: Behavioral
intervention name: Education Session on General Health
description: Participants in the control group received a group education session in a similar format with that of the intervention group delivered by trained Korean community health educators. Different from the intervention group, the education focused on general health education and primary prevention issues, including routine health examinations and screening for various diseases such as cancer. Korean version of work and communication with a physician, and arranging transportation. standard printed materials and guidelines related to the education contents were also provided, including CRC screening guidelines.
arm group label: general health education
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Grace X Ma, PhD
role: Principal Investigator
affiliation: Temple University
facility: 
country: United States
url: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6746426/
description: Related Info
citation: Ma GX, Lee M, Beeber M, Das R, Feng Z, Wang MQ, Tan Y, Zhu L, Navder K, Shireman TI, Siu P, Rhee J, Nguyen MT. Community-Clinical Linkage Intervention to Improve Colorectal Cancer Screening Among Underserved Korean Americans. Cancer Health Disparities. 2019;3:e1-e15. Epub 2019 Aug 19.
PMID: 31528846
responsible party type: Sponsor
mesh term: Colorectal Neoplasms