<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/NCT04444232</url>
  </required_header>
  <id_info>
    <org_study_id>RG1001018</org_study_id>
    <secondary_id>P30CA015704</secondary_id>
    <secondary_id>NCI-2020-04236</secondary_id>
    <secondary_id>8182</secondary_id>
    <nct_id>NCT04444232</nct_id>
  </id_info>
  <brief_title>Cancer Communication Within Hispanic Social Networks</brief_title>
  <official_title>Cancer Communication Within Social Networks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial examines cancer communication within Hispanic social networks. Hispanics have the&#xD;
      lowest colorectal cancer screening rate of any major ethnic group and health interventions&#xD;
      are crucially needed among Hispanics. Patient decision aids are health communication&#xD;
      interventions designed to provide patients with targeted health information and have shown to&#xD;
      improve colorectal cancer screening rates among Hispanics. The goal of this study is to&#xD;
      investigate, in a sample of Hispanics, how a colorectal cancer decision aid aimed at&#xD;
      increasing individuals' colorectal cancer screening behavior has effects on their alters'&#xD;
      intention to get screened for colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE:&#xD;
&#xD;
      Participants view an educational video on cancer and cancer screening options over 12&#xD;
      minutes. Participants also complete a phone survey over 10-15 minutes before attending the&#xD;
      video session and 2 months after the video session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2014</start_date>
  <completion_date type="Actual">March 9, 2015</completion_date>
  <primary_completion_date type="Actual">February 10, 2015</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients' communication with their families, friends, and co-workers about colorectal cancer (CRC) screening</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will be assessed using a single dichotomized question with two response options ('yes' or 'no'). CRC communication constitutes in-person conversation, email, phone, or post on social media (e.g., blog, Twitter, Facebook). Will also assess the characteristics of the alters by asking the patients two questions on social-tie dimensions: 1) contact frequency (never, rarely, sometimes, often, or very often) and 2) personal relationship (acquaintance , close friend , co-worker, relatives, or spouse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alters' intent to become screened for CRC in the next six months</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Intent will be assessed using a single categorical item with three response options (definitely planning to be screened, considering being screened, not considering being screened).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Colorectal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Health services research (educational video, survey)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants view an educational video on cancer and cancer screening options over 12 minutes. Participants also complete a phone survey over 10-15 minutes before attending the video session and 2 months after the video session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Media Intervention</intervention_name>
    <description>View an educational video</description>
    <arm_group_label>Health services research (educational video, survey)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Complete survey</description>
    <arm_group_label>Health services research (educational video, survey)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identify as &quot;Hispanic&quot; or &quot;Latino&quot;&#xD;
&#xD;
          -  Have no family history of CRC&#xD;
&#xD;
          -  Have no personal history of pre-cancerous (adenomatous) colonic polyps&#xD;
&#xD;
          -  Have not had either an annual fecal occult blood test (FOBT) within the past year or&#xD;
             colonoscopy within the last 10 years (defined as up-to-date with CRC screening by&#xD;
             current United States [U.S.] Preventive Services Task Force recommendations)&#xD;
&#xD;
          -  Have at least two family members, friends, or co-workers who are ages 50-75&#xD;
&#xD;
          -  Alters will be eligible if they are ages 50-75&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda Ko</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04444232
org study id: RG1001018
secondary id: P30CA015704
secondary id: NCI-2020-04236
secondary id: 8182
nct id: NCT04444232
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial examines cancer communication within Hispanic social networks. Hispanics have the
      lowest colorectal cancer screening rate of any major ethnic group and health interventions
      are crucially needed among Hispanics. Patient decision aids are health communication
      interventions designed to provide patients with targeted health information and have shown to
      improve colorectal cancer screening rates among Hispanics. The goal of this study is to
      investigate, in a sample of Hispanics, how a colorectal cancer decision aid aimed at
      increasing individuals' colorectal cancer screening behavior has effects on their alters'
      intention to get screened for colorectal cancer.
OUTLINE:

      Participants view an educational video on cancer and cancer screening options over 12
      minutes. Participants also complete a phone survey over 10-15 minutes before attending the
      video session and 2 months after the video session.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patients' communication with their families, friends, and co-workers about colorectal cancer (CRC) screening
time frame: Up to 6 months
description: Will be assessed using a single dichotomized question with two response options ('yes' or 'no'). CRC communication constitutes in-person conversation, email, phone, or post on social media (e.g., blog, Twitter, Facebook). Will also assess the characteristics of the alters by asking the patients two questions on social-tie dimensions: 1) contact frequency (never, rarely, sometimes, often, or very often) and 2) personal relationship (acquaintance , close friend , co-worker, relatives, or spouse).
measure: Alters' intent to become screened for CRC in the next six months
time frame: Up to 6 months
description: Intent will be assessed using a single categorical item with three response options (definitely planning to be screened, considering being screened, not considering being screened).
arm group label: Health services research (educational video, survey)
arm group type: Experimental
description: Participants view an educational video on cancer and cancer screening options over 12 minutes. Participants also complete a phone survey over 10-15 minutes before attending the video session and 2 months after the video session.
intervention type: Other
intervention name: Media Intervention
description: View an educational video
arm group label: Health services research (educational video, survey)
intervention type: Other
intervention name: Survey Administration
description: Complete survey
arm group label: Health services research (educational video, survey)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Linda Ko
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No