<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/NCT03248661</url>
  </required_header>
  <id_info>
    <org_study_id>14-0662-P3H</org_study_id>
    <nct_id>NCT03248661</nct_id>
  </id_info>
  <brief_title>Assessing Repeat Fit Testing for CRC</brief_title>
  <acronym>ARFT</acronym>
  <official_title>Assessing Repeat Annual FIT Screening for Colo-Rectal Cancer (CRC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Richard Crosby</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will randomly assign 220 men and women to either a social media intervention or a&#xD;
      standard reminder system to have a repeat screening test for colo-rectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Only persons initially screening by FIT (through a Rural Cancer Prevention Center service&#xD;
      program) will be eligible for study participation. The objective is to test a social&#xD;
      media-based intervention designed to promote annual repeat colo-rectal cancer screening using&#xD;
      the Fecal Immunochemical Test (FIT) among person who have taken the FIT test once before. 220&#xD;
      men and women (50 to 75 years of age) will be recruited and randomly assigned to either the&#xD;
      intervention condition (monthly social media contact) or a control condition (standard of&#xD;
      care reminder for repeat testing one month before the annual test is due). The dependent&#xD;
      variable will be whether volunteers requested and retuned a FIT kit with 60 days of the&#xD;
      annual due date (one year from their initial screening).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Actual">September 25, 2018</completion_date>
  <primary_completion_date type="Actual">September 25, 2018</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary endpoint is a received completed FIT kit within 15 months after the participant received results from the original FIT test</measure>
    <time_frame>15 months</time_frame>
    <description>the endpoint is a received completed FIT kit</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Colo-rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention media condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>monthly social media contact will be used to keep people connected to the idea of completing a second screening test 12 months after their last one.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control condition</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>this group will receive only a standard reminder for the annual repeat test, one month before the test due date</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Now I'm Telling You</intervention_name>
    <description>Messages will be sent trough Facebook, Twitter, Instagram, e-mail, texting or other electronic/social media specified by study volunteers.</description>
    <arm_group_label>Intervention media condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must have completed and returned an initial FIT kit to us as part of a Rural Cancer&#xD;
             Prevention Center service program to the community&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  visible blood in stool or prior diagnosis of cool-rectal cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 24, 2015</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Richard Crosby</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal 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/NCT03248661
org study id: 14-0662-P3H
nct id: NCT03248661
lead sponsor: 
collaborator: 
has dmc: No
This study will randomly assign 220 men and women to either a social media intervention or a
      standard reminder system to have a repeat screening test for colo-rectal cancer.
Only persons initially screening by FIT (through a Rural Cancer Prevention Center service
      program) will be eligible for study participation. The objective is to test a social
      media-based intervention designed to promote annual repeat colo-rectal cancer screening using
      the Fecal Immunochemical Test (FIT) among person who have taken the FIT test once before. 220
      men and women (50 to 75 years of age) will be recruited and randomly assigned to either the
      intervention condition (monthly social media contact) or a control condition (standard of
      care reminder for repeat testing one month before the annual test is due). The dependent
      variable will be whether volunteers requested and retuned a FIT kit with 60 days of the
      annual due date (one year from their initial screening).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Primary endpoint is a received completed FIT kit within 15 months after the participant received results from the original FIT test
time frame: 15 months
description: the endpoint is a received completed FIT kit
arm group label: Intervention media condition
arm group type: Experimental
description: monthly social media contact will be used to keep people connected to the idea of completing a second screening test 12 months after their last one.
arm group label: control condition
arm group type: No Intervention
description: this group will receive only a standard reminder for the annual repeat test, one month before the test due date
intervention type: Behavioral
intervention name: Now I'm Telling You
description: Messages will be sent trough Facebook, Twitter, Instagram, e-mail, texting or other electronic/social media specified by study volunteers.
arm group label: Intervention media condition
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Richard Crosby
investigator title: PI
mesh term: Rectal Neoplasms