<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/NCT04464668</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-20560</org_study_id>
    <nct_id>NCT04464668</nct_id>
  </id_info>
  <brief_title>Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health</brief_title>
  <acronym>CARES-REACH</acronym>
  <official_title>Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>H. Lee Moffitt Cancer Center and Research Institute</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to assess the impact of the CARES-REACH intervention on colorectal cancer&#xD;
      screening rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will not accrue individual patients. Instead, the investigators are collecting&#xD;
      process data from health care providers to determine the procedures that impact or help to&#xD;
      increase colorectal cancer screening rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">November 2025</completion_date>
  <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Colorectal Cancer Screening Rates - Initial FIT</measure>
    <time_frame>Years 1-5</time_frame>
    <description>Percentage of patients who complete initial Fecal Immunochemical Test (FIT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Colorectal Cancer Screening Rates - Repeat FIT</measure>
    <time_frame>Years 1-5</time_frame>
    <description>Percentage of patients who complete a repeat Fecal Immunochemical Test (FIT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in Screening Rates</measure>
    <time_frame>Years 2-5</time_frame>
    <description>Screening rate differences to determine how variables such as clinic setting (rural vs urban), population characteristics such as nativity (foreign born status), language preference, education, income, health insurance, etc. differentially impact annual clinic Colorectal Cancer (CRC) screening rates.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">49</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Wave 1 Only: Clinics using CARES Intervention</arm_group_label>
    <description>Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics to implement the Colorectal Cancer Awareness, Research, Education &amp; Screening (CARES) intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wave 1 Only: Control Clinics</arm_group_label>
    <description>Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics as control (usual care) clinics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>All Clinics</arm_group_label>
    <description>For Wave 2, the 7 clinics in the control group will roll out as intervention clinic, thus, all 14 clinics will be exposed to the intervention by year 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Provider Tools</intervention_name>
    <description>Providers will be trained to use Electronic Medical Record (EMR) tools and prompts, and an organization wide cancer control champion will be trained to motivate providers and navigate patients.</description>
    <arm_group_label>All Clinics</arm_group_label>
    <arm_group_label>Wave 1 Only: Clinics using CARES Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Provider surveys</intervention_name>
    <description>Remote/electronic data collection surveys will be conducted with clinic institution leaders, cancer control champions, and providers from various clinic locations to solicit feedback about implementation processes at three time points (baseline, mid-point and end of study implementation)</description>
    <arm_group_label>All Clinics</arm_group_label>
    <arm_group_label>Wave 1 Only: Clinics using CARES Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Staff and providers from the two participating Federally Qualified Health Care systems -&#xD;
        Central Florida Health Centers and Manatee County Rural Health Services.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Staff and providers working in a clinic within one of the two participating systems&#xD;
&#xD;
          -  Involved in adult patient care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Staff and providers who are not engaged in directing or decisions related to&#xD;
             colo-rectal cancer screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clement K Gwede, PhD MPH RN FAAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moffitt Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fecal Immunochemical Test</keyword>
  <keyword>F.I.T.</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/NCT04464668
org study id: MCC-20560
nct id: NCT04464668
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is to assess the impact of the CARES-REACH intervention on colorectal cancer
      screening rates.
This study will not accrue individual patients. Instead, the investigators are collecting
      process data from health care providers to determine the procedures that impact or help to
      increase colorectal cancer screening rates.
observational model: Case-Only
time perspective: Prospective
measure: Change in Colorectal Cancer Screening Rates - Initial FIT
time frame: Years 1-5
description: Percentage of patients who complete initial Fecal Immunochemical Test (FIT)
measure: Change in Colorectal Cancer Screening Rates - Repeat FIT
time frame: Years 1-5
description: Percentage of patients who complete a repeat Fecal Immunochemical Test (FIT)
measure: Differences in Screening Rates
time frame: Years 2-5
description: Screening rate differences to determine how variables such as clinic setting (rural vs urban), population characteristics such as nativity (foreign born status), language preference, education, income, health insurance, etc. differentially impact annual clinic Colorectal Cancer (CRC) screening rates.
arm group label: Wave 1 Only: Clinics using CARES Intervention
description: Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics to implement the Colorectal Cancer Awareness, Research, Education & Screening (CARES) intervention.
arm group label: Wave 1 Only: Control Clinics
description: Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics as control (usual care) clinics.
arm group label: All Clinics
description: For Wave 2, the 7 clinics in the control group will roll out as intervention clinic, thus, all 14 clinics will be exposed to the intervention by year 2.
intervention type: Behavioral
intervention name: Provider Tools
description: Providers will be trained to use Electronic Medical Record (EMR) tools and prompts, and an organization wide cancer control champion will be trained to motivate providers and navigate patients.
arm group label: All Clinics
arm group label: Wave 1 Only: Clinics using CARES Intervention
intervention type: Behavioral
intervention name: Provider surveys
description: Remote/electronic data collection surveys will be conducted with clinic institution leaders, cancer control champions, and providers from various clinic locations to solicit feedback about implementation processes at three time points (baseline, mid-point and end of study implementation)
arm group label: All Clinics
arm group label: Wave 1 Only: Clinics using CARES Intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clement K Gwede, PhD MPH RN FAAN
role: Principal Investigator
affiliation: Moffitt Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms