<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/NCT03817905</url>
  </required_header>
  <id_info>
    <org_study_id>CASE1219</org_study_id>
    <nct_id>NCT03817905</nct_id>
  </id_info>
  <brief_title>Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach</brief_title>
  <official_title>Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to determine whether a patient navigator can help improve follow up care&#xD;
      after a stool test shows the presence of blood or other abnormal markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants who recently had a stool test that had abnormal results will be asked to&#xD;
      participate in this study in order to determine whether the use of a navigator can increase&#xD;
      the use of colonoscopy, which is the recommended follow up to an abnormal stool test. A&#xD;
      navigator is an individual trained to help patients access necessary health care services and&#xD;
      understand the test results and next steps. Participants will be asked to meet the navigator&#xD;
      at their colonoscopy appointment and discuss any problems that are experienced in getting the&#xD;
      colonoscopy done. This will take about 10 minutes to complete. Participants will tell him or&#xD;
      her in their own words how the experience was and whether they faced any barriers to&#xD;
      scheduling and colonoscopy completion. Study personnel will also look at participants'&#xD;
      electronic medical record to see what testing participants had done that prompted the need&#xD;
      for colonoscopy.The study will include about 30 people.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants completing a follow-up colonoscopy procedure</measure>
    <time_frame>Up to 6 months from start of study</time_frame>
    <description>Feasibility of a navigator based intervention to improve follow up will be determined by comparing the colonoscopy completion rate to historical controls. This will be measured as number of participants completing a follow-up colonoscopy procedure.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Positive FIT or Stool DNA Testing Follow up</condition>
  <arm_group>
    <arm_group_label>Patient navigator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant meets the patient navigator at their colonoscopy appointment and discusses any problems they experienced in getting the colonoscopy done. Participant will tell navigator in their own words their experience and whether they faced any barriers to scheduling and colonoscopy completion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient navigator</intervention_name>
    <description>Intervention will utilize staff at the Seidman Cancer Center who are trained in patient navigation and have experience in navigating patients for breast cancer screening as well as sickle cell disease. The staff will undergo training for this study by study principal investigators which will include the target participant population, necessary steps in the navigation process and data that will be collected. In addition, they will receive brief training in supportive, listening technique. They will also be furnished with a telephone script for the initial participant contact.</description>
    <arm_group_label>Patient navigator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Positive test for FIT or sDNA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Does not understand English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory Cooper, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gregory Cooper, MD</last_name>
    <phone>1-800-641-2422</phone>
    <email>CTUReferral@UHhospitals.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gregory Cooper, MD</last_name>
      <phone>800-641-2422</phone>
      <email>CTUReferral@UHhospitals.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>Fecal Immunochemical Testing</keyword>
  <!-- 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/NCT03817905
org study id: CASE1219
nct id: NCT03817905
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to determine whether a patient navigator can help improve follow up care
      after a stool test shows the presence of blood or other abnormal markers.
Participants who recently had a stool test that had abnormal results will be asked to
      participate in this study in order to determine whether the use of a navigator can increase
      the use of colonoscopy, which is the recommended follow up to an abnormal stool test. A
      navigator is an individual trained to help patients access necessary health care services and
      understand the test results and next steps. Participants will be asked to meet the navigator
      at their colonoscopy appointment and discuss any problems that are experienced in getting the
      colonoscopy done. This will take about 10 minutes to complete. Participants will tell him or
      her in their own words how the experience was and whether they faced any barriers to
      scheduling and colonoscopy completion. Study personnel will also look at participants'
      electronic medical record to see what testing participants had done that prompted the need
      for colonoscopy.The study will include about 30 people.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of participants completing a follow-up colonoscopy procedure
time frame: Up to 6 months from start of study
description: Feasibility of a navigator based intervention to improve follow up will be determined by comparing the colonoscopy completion rate to historical controls. This will be measured as number of participants completing a follow-up colonoscopy procedure.
arm group label: Patient navigator
arm group type: Experimental
description: Participant meets the patient navigator at their colonoscopy appointment and discusses any problems they experienced in getting the colonoscopy done. Participant will tell navigator in their own words their experience and whether they faced any barriers to scheduling and colonoscopy completion.
intervention type: Other
intervention name: Patient navigator
description: Intervention will utilize staff at the Seidman Cancer Center who are trained in patient navigation and have experience in navigating patients for breast cancer screening as well as sickle cell disease. The staff will undergo training for this study by study principal investigators which will include the target participant population, necessary steps in the navigation process and data that will be collected. In addition, they will receive brief training in supportive, listening technique. They will also be furnished with a telephone script for the initial participant contact.
arm group label: Patient navigator
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Gregory Cooper, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
last name: Gregory Cooper, MD
phone: 1-800-641-2422
email: CTUReferral@UHhospitals.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor