<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/NCT02192034</url>
  </required_header>
  <id_info>
    <org_study_id>ACS255086</org_study_id>
    <nct_id>NCT02192034</nct_id>
  </id_info>
  <brief_title>Optimizing Navigation to Successful Colorectal Cancer Screening</brief_title>
  <official_title>Optimizing Navigation to Successful Colorectal Cancer Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer is the second leading cause of death from cancer in the United States. Two&#xD;
      major barriers to successful colorectal cancer screening are appointment keeping and proper&#xD;
      bowel preparation. The purpose of this study is to test the efficacy of a patient navigation&#xD;
      program to increase colorectal cancer screening at Rush University Medical Center. The&#xD;
      investigators hypothesize that colorectal cancer screening will be improved for subjects who&#xD;
      utilize a patient navigator.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Navigation role in colorectal cancer screening</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Primary endpoint will be the role of navigation to obtain colonoscopy attendance with adequate colonoscopy preparation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Colorectal Cancer Screening</condition>
  <arm_group>
    <arm_group_label>Navigation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive standard clinic instructions for the colonoscopy and two additional phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will receive only clinic instructions without intervention from the patient navigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Navigation</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Navigation Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject deemed appropriate for colorectal cancer screening by colonoscopy by a primary&#xD;
             care physician&#xD;
&#xD;
          -  Age 50 or greater or 40 or greater with family history of colorectal cancer in first&#xD;
             degree relative&#xD;
&#xD;
          -  Average risk for screening as defined as absence of symptomatic abdominal pain and&#xD;
             active GI bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 75 years old&#xD;
&#xD;
          -  Congestive Heart Failure&#xD;
&#xD;
          -  Chronic Obstructive Pulmonary Disease&#xD;
&#xD;
          -  Myocardial Infarction&#xD;
&#xD;
          -  Weight greater than 350 pounds&#xD;
&#xD;
          -  Anticoagulation&#xD;
&#xD;
          -  Inability to speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua E Melson, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>June 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>October 26, 2015</last_update_submitted>
  <last_update_submitted_qc>October 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>Colon cancer</keyword>
  <keyword>screening</keyword>
  <keyword>navigation</keyword>
  <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/NCT02192034
org study id: ACS255086
nct id: NCT02192034
lead sponsor: 
collaborator: 
has dmc: No
Colorectal cancer is the second leading cause of death from cancer in the United States. Two
      major barriers to successful colorectal cancer screening are appointment keeping and proper
      bowel preparation. The purpose of this study is to test the efficacy of a patient navigation
      program to increase colorectal cancer screening at Rush University Medical Center. The
      investigators hypothesize that colorectal cancer screening will be improved for subjects who
      utilize a patient navigator.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Screening
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Navigation role in colorectal cancer screening
time frame: Up to 90 days
description: Primary endpoint will be the role of navigation to obtain colonoscopy attendance with adequate colonoscopy preparation.
arm group label: Navigation Group
arm group type: Experimental
description: This group will receive standard clinic instructions for the colonoscopy and two additional phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure.
arm group label: Control
arm group type: Placebo Comparator
description: This group will receive only clinic instructions without intervention from the patient navigator.
intervention type: Behavioral
intervention name: Navigation
arm group label: Control
arm group label: Navigation Group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joshua E Melson, MD, MPH
role: Principal Investigator
affiliation: Rush University Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms