<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/NCT03031171</url>
  </required_header>
  <id_info>
    <org_study_id>SB09/10-034</org_study_id>
    <secondary_id>8P20GM103440-11</secondary_id>
    <nct_id>NCT03031171</nct_id>
  </id_info>
  <brief_title>Community Engaged Colon Cancer Screening Patient Navigator Program</brief_title>
  <official_title>Community Engaged Colon Cancer Screening Patient Navigator Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nevada, Reno</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nevada, Reno</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>
      The goal of the project is to increase colorectal cancer screening within the priority&#xD;
      population of female and male adults age 50 to 85 in Northern Nevada. A successful&#xD;
      community-based cancer patient navigator program will be modified in partnership with the&#xD;
      community into a multi-level screening intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the project is to increase colorectal cancer screening within the priority&#xD;
      population of female and male adults age 50 to 85 in Northern Nevada. A successful&#xD;
      community-based cancer patient navigator program will be modified in partnership with the&#xD;
      community into a multi-level screening intervention. A well-tested behavioral change theory&#xD;
      (the health belief model; HBM) will guide the intervention and the relative efficacy of a)&#xD;
      the theory's constructs and b) evidence-based intervention practices on increasing screening&#xD;
      rates will be examined. Although increased screening rates are associated with program&#xD;
      navigators, it is unclear which program components are related to the outcome. In addition,&#xD;
      there is ambiguity surrounding a) the temporal impact of the HBM on cancer screening and b)&#xD;
      the relationships among the model's constructs. A quasi-experimental time-series design will&#xD;
      be used to evaluate the outcome objective of increased screening rates by comparing screening&#xD;
      rates one year pre- and post-intervention and whether navigated patients are better prepared&#xD;
      for screening than non-navigated patients. A minimum of 315 participants (to correspond with&#xD;
      a power level of .80) in the navigator program will be surveyed on knowledge about colorectal&#xD;
      cancer, and satisfaction with and usefulness of the program. The anticipated contribution of&#xD;
      the project will be to increase community efficacy, colorectal cancer screening in the&#xD;
      project area, and to reduce cancer morbidity and mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">August 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Colonoscopy completion</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">415</enrollment>
  <condition>ColoRectal Cancer</condition>
  <arm_group>
    <arm_group_label>Navigated: Screening patient navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinic patients who received navigation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Navigated</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Randomly matched sample of non-navigated clinic patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Screening patient navigation</intervention_name>
    <description>The program offered assistance with scheduling, paperwork, arranging transportation, answering questions and providing education about screening and colorectal cancer.</description>
    <arm_group_label>Navigated: Screening patient navigation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-Navigated</intervention_name>
    <description>Randomly matched sample of non-navigated clinic patients</description>
    <arm_group_label>Non-Navigated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Insurance, no history of colon cancer,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No experience of relevant GI symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Devereux, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nevada, Reno</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univeristy of Nevada, Reno</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>January 21, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 21, 2017</last_update_submitted>
  <last_update_submitted_qc>January 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>community engagement, navigation, cancer screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic 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/NCT03031171
org study id: SB09/10-034
secondary id: 8P20GM103440-11
nct id: NCT03031171
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of the project is to increase colorectal cancer screening within the priority
      population of female and male adults age 50 to 85 in Northern Nevada. A successful
      community-based cancer patient navigator program will be modified in partnership with the
      community into a multi-level screening intervention.
The goal of the project is to increase colorectal cancer screening within the priority
      population of female and male adults age 50 to 85 in Northern Nevada. A successful
      community-based cancer patient navigator program will be modified in partnership with the
      community into a multi-level screening intervention. A well-tested behavioral change theory
      (the health belief model; HBM) will guide the intervention and the relative efficacy of a)
      the theory's constructs and b) evidence-based intervention practices on increasing screening
      rates will be examined. Although increased screening rates are associated with program
      navigators, it is unclear which program components are related to the outcome. In addition,
      there is ambiguity surrounding a) the temporal impact of the HBM on cancer screening and b)
      the relationships among the model's constructs. A quasi-experimental time-series design will
      be used to evaluate the outcome objective of increased screening rates by comparing screening
      rates one year pre- and post-intervention and whether navigated patients are better prepared
      for screening than non-navigated patients. A minimum of 315 participants (to correspond with
      a power level of .80) in the navigator program will be surveyed on knowledge about colorectal
      cancer, and satisfaction with and usefulness of the program. The anticipated contribution of
      the project will be to increase community efficacy, colorectal cancer screening in the
      project area, and to reduce cancer morbidity and mortality.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Colonoscopy completion
time frame: 2 years
arm group label: Navigated: Screening patient navigation
arm group type: Experimental
description: Clinic patients who received navigation
arm group label: Non-Navigated
arm group type: Active Comparator
description: Randomly matched sample of non-navigated clinic patients
intervention type: Behavioral
intervention name: Screening patient navigation
description: The program offered assistance with scheduling, paperwork, arranging transportation, answering questions and providing education about screening and colorectal cancer.
arm group label: Navigated: Screening patient navigation
intervention type: Behavioral
intervention name: Non-Navigated
description: Randomly matched sample of non-navigated clinic patients
arm group label: Non-Navigated
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Devereux, PhD, MPH
role: Principal Investigator
affiliation: University of Nevada, Reno
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colonic Neoplasms
sharing ipd: No