<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/NCT03246438</url>
  </required_header>
  <id_info>
    <org_study_id>827818</org_study_id>
    <nct_id>NCT03246438</nct_id>
  </id_info>
  <brief_title>Choice Architecture and Colorectal Cancer Screening Outreach</brief_title>
  <official_title>Choice Architecture and Mailed Outreach for Colorectal Cancer Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</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 pilot study is a 3-arm randomized control trial assessing the effectiveness of&#xD;
      sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy&#xD;
      outreach only, in patients between 50-74 years old, who have received care at the University&#xD;
      City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and&#xD;
      are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control),&#xD;
      Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test)&#xD;
      (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active&#xD;
      Choice).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study is a 3-arm randomized control trial assessing the effectiveness of&#xD;
      sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The&#xD;
      investigators will randomize participants to one of three study arms:&#xD;
&#xD;
      Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by&#xD;
      mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT&#xD;
      (Active Choice).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2017</start_date>
  <completion_date type="Actual">July 14, 2018</completion_date>
  <primary_completion_date type="Actual">March 14, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CRC screening completion</measure>
    <time_frame>4 months</time_frame>
    <description>The percentage of participants who successfully complete FIT or colonoscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Choice of screening test</measure>
    <time_frame>4 months</time_frame>
    <description>The percentage of participants who choose either screening method (FIT vs. colonoscopy)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">423</enrollment>
  <condition>Cancer of Colon</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colonoscopy only outreach and follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequential Choice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colonoscopy outreach + mailed FIT follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Choice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colonoscopy + mailed FIT outreach and follow-up</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colonoscopy only</intervention_name>
    <description>Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colonoscopy outreach + mailed FIT follow-up</intervention_name>
    <description>Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit.</description>
    <arm_group_label>Sequential Choice</arm_group_label>
    <other_name>Sequential Choice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colonoscopy + Mailed FIT outreach and follow-up</intervention_name>
    <description>Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent.</description>
    <arm_group_label>Active Choice</arm_group_label>
    <other_name>Active Choice</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 50 and 74 years old&#xD;
&#xD;
          -  Has a primary care provider who is a University City or Valley Forge Family Medicine&#xD;
             provider&#xD;
&#xD;
          -  Has had at least 2 office visits at either practice&#xD;
&#xD;
          -  Is due for colorectal cancer screening&#xD;
&#xD;
          -  Is asymptomatic for CRC&#xD;
&#xD;
          -  Subject's zip code is within the Philadelphia-Wilmington-Camden Metropolitan&#xD;
             Statistical Area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, or FOBT/FIT&#xD;
             within twelve months of chart review (we will exclude patients who self-report any of&#xD;
             the above procedures)&#xD;
&#xD;
          -  Has a history of CRC or colonic polyps&#xD;
&#xD;
          -  Has a history of GI cancer&#xD;
&#xD;
          -  Has a history of confirmed Inflammatory Bowel Disease (IBD)&#xD;
&#xD;
          -  has a history of colitis other than Crohns disease or ulcerative colitis)&#xD;
&#xD;
          -  Has a first degree relative that has been diagnosed with CRC&#xD;
&#xD;
          -  Has had a colectomy&#xD;
&#xD;
          -  Has been diagnosed with Familial Adenomatous Polyposis (FAP)&#xD;
&#xD;
          -  Has been diagnosed with Lynch Syndrome (i.e. HNPCC)&#xD;
&#xD;
          -  Has iron-deficiency anemia&#xD;
&#xD;
          -  Has a history of lower GI bleeding&#xD;
&#xD;
          -  Has metastatic (Stage IV) blood or solid tumor cancer&#xD;
&#xD;
          -  Has end stage renal disease&#xD;
&#xD;
          -  Has cirrhosis&#xD;
&#xD;
          -  Has heart failure&#xD;
&#xD;
          -  Has dementia&#xD;
&#xD;
          -  Has any other condition that, in the opinion of the investigator, excludes the patient&#xD;
             from participating in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shivan Mehta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chyke Doubeni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 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 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Undecided</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/NCT03246438
org study id: 827818
nct id: NCT03246438
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study is a 3-arm randomized control trial assessing the effectiveness of
      sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy
      outreach only, in patients between 50-74 years old, who have received care at the University
      City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and
      are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control),
      Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test)
      (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active
      Choice).
This pilot study is a 3-arm randomized control trial assessing the effectiveness of
      sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The
      investigators will randomize participants to one of three study arms:

      Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by
      mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT
      (Active Choice).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Investigator)
measure: CRC screening completion
time frame: 4 months
description: The percentage of participants who successfully complete FIT or colonoscopy
measure: Choice of screening test
time frame: 4 months
description: The percentage of participants who choose either screening method (FIT vs. colonoscopy)
arm group label: Control
arm group type: Experimental
description: Colonoscopy only outreach and follow-up
arm group label: Sequential Choice
arm group type: Experimental
description: Colonoscopy outreach + mailed FIT follow-up
arm group label: Active Choice
arm group type: Experimental
description: Colonoscopy + mailed FIT outreach and follow-up
intervention type: Behavioral
intervention name: Colonoscopy only
description: Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy.
arm group label: Control
other name: Control
intervention type: Behavioral
intervention name: Colonoscopy outreach + mailed FIT follow-up
description: Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit.
arm group label: Sequential Choice
other name: Sequential Choice
intervention type: Behavioral
intervention name: Colonoscopy + Mailed FIT outreach and follow-up
description: Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent.
arm group label: Active Choice
other name: Active Choice
criteria: 
gender: All
minimum age: 50 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shivan Mehta, MD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Chyke Doubeni, MD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colonic Neoplasms
sharing ipd: Undecided