<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/NCT04406714</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC2056</org_study_id>
    <secondary_id>4UH3CA233251-02</secondary_id>
    <nct_id>NCT04406714</nct_id>
  </id_info>
  <brief_title>Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)</brief_title>
  <acronym>SCORE</acronym>
  <official_title>Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE): A State-Level Program to Reduce Colorectal Cancer Burden in Vulnerable Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>East Carolina University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</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 will test the effectiveness of mailing fecal immunochemical tests (FITs) in&#xD;
      increasing colorectal cancer (CRC) screening rates in U.S. adults ages 45-75. We are&#xD;
      implementing this study in two age groups, 45-49 years and 50-75 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trial (Age Group 50-75) This randomized controlled trial assesses the effectiveness,&#xD;
      feasibility, acceptability, and cost-effectiveness of mailing FITs from a central location to&#xD;
      patients served by FQHCs. Subjects are randomly selected and assigned to receive either a&#xD;
      mailed FIT intervention (Arm 1: Trial Mailed FIT Intervention - Age Group 50-75) or usual&#xD;
      care (Arm 2: Trial Usual Care - Age Group 50-75). To assess United States Preventive Services&#xD;
      Task Force recommendations for annual screening, we will mail subjects one round of FIT per&#xD;
      year for up to two years.&#xD;
&#xD;
      Sub-study (Age Group 45-49) A sub-study assesses the effectiveness of mailing FITs from a&#xD;
      central location to patients who are 45-49 years of age and newly eligible for CRC screening.&#xD;
      The sub-study also assesses the impact of varying the appearance of the FIT packet mailing&#xD;
      envelope on FIT return. All eligible patients from one FQHC clinic site are randomly assigned&#xD;
      to receive either a mailed FIT intervention that includes an enhanced mailing envelope (Arm&#xD;
      3: Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) or a plain envelope&#xD;
      (Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49).&#xD;
&#xD;
      The Trial (Age Group 50-75) and the Sub-study (Age Group 45-49) also assess the effectiveness&#xD;
      of delivering patient navigation from a central location to facilitate follow up colonoscopy&#xD;
      for patients with a positive (abnormal) FIT result.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>
    <intervention_model_description>Trial (Age Group 50-75) Using a randomized controlled trial study design, subjects are assigned to one of two arms: Arm 1: Trial Mailed FIT Intervention; or Arm 2: Trial Usual Care. Arm 1 (intervention) receives a mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the study (i.e., two annual rounds of mailed FIT).&#xD;
Sub-study (Age Group 45-49) Subjects, ages 45-49, are randomly assigned to one of two arms: Arm 3: Sub-Study Mailed FIT Intervention - Enhanced Envelope; or Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope. Subjects in both Arm 3 and Arm 4 receive mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the sub-study (i.e., one annual round of mailed FIT).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects, ages 50-75, who complete CRC screening within 6 months (Trial - Age Group 50-75)</measure>
    <time_frame>6 months after randomization</time_frame>
    <description>Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who complete CRC screening using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test [FOBT], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who return a completed mailed FIT at 60 days (Trial - Age Group 50-75)</measure>
    <time_frame>60 days after randomization</time_frame>
    <description>Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) who return a completed FIT per electronic health record review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who complete a follow-up (diagnostic) colonoscopy at 6 months (Trial - Age Group 50-75)</measure>
    <time_frame>6 months after diagnostic colonoscopy result date</time_frame>
    <description>Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who complete a follow-up (diagnostic) colonoscopy per electronic health record review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of CRCs and advanced adenomas detected at 12 months (Trial - Age Group 50-75)</measure>
    <time_frame>12 months after screening or diagnostic colonoscopy result date</time_frame>
    <description>Number of CRCs and advanced adenomas detected among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who complete a screening or follow-up (diagnostic) colonoscopy per electronic health record review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days from CRC diagnosis to the date of evaluation for CRC treatment (Trial - Age Group 50-75)</measure>
    <time_frame>Up to 12 months after CRC diagnosis</time_frame>
    <description>Number of days from CRC diagnosis to the date of evaluation for CRC treatment among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of CRC diagnosis and evaluation for CRC treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects who receive referral for cancer treatment (Trial - Age Group 50-75)</measure>
    <time_frame>6 months after cancer diagnosis date</time_frame>
    <description>Number of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who receive referral for cancer treatment among individuals diagnosed with CRC per electronic health record review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of mailed FITs completed after two rounds of annual FIT outreach (Trial - Age Group 50-75)</measure>
    <time_frame>Up to 18 months after randomization</time_frame>
    <description>Number of mailed FITs completed (0, 1, or 2) by subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) after two rounds of annual FIT outreach, per electronic health record review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental cost of each additional patient screened in the intervention arm compared to usual care (Trial - Age Group 50-75)</measure>
    <time_frame>Through study completion, up to 36 months after randomization</time_frame>
    <description>Comparison of the programmatic costs incurred and number of subjects screened in Arm 1(Trial Mailed FIT Intervention - Age Group 50-75) compared to Arm 2 (Trial Usual Care - Age Group 50-75), measured as cost of intervention minus the cost of usual care, divided by the number screened in Arm 1 minus the number screened in Arm 2. Intervention costs will be assessed using periodic episodes of direct observation of mailed FIT outreach activities, time logs maintained by the intervention team, and assembly of administrative data capturing non-personnel/non-labor expenditures, such as costs associated with materials printing, FIT processing, and mailing costs. Usual care costs will be assessed using a combination of clinic observations and interviews with staff.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects, ages 45-49, who are current with CRC screening (Sub-study - Age Group 45-49)</measure>
    <time_frame>6 months after randomization</time_frame>
    <description>The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who who are current with any CRC screening compared to baseline, using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test [FOBT], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects, ages 45-49, who completed mailed FIT at 60 days (Sub-study - Age Group 45-49)</measure>
    <time_frame>60 days after randomization</time_frame>
    <description>The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) compared to subjects in Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who return a completed FIT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who complete a follow-up diagnostic colonoscopy at 60 days (Sub-study - Age Group 45-49)</measure>
    <time_frame>60 days after abnormal FIT result date</time_frame>
    <description>Proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-40) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who complete a follow-up (diagnostic) colonoscopy per electronic health record review.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of participants who return a completed mailed FIT at 90 days (exploratory outcome) (Trial Age Group 50-75)</measure>
    <time_frame>90 days after randomization</time_frame>
    <description>Proportion of participants in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) who return a completed FIT per electronic health record review.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of days from abnormal FIT result date to diagnostic colonoscopy (Trial - Age Group 50-75)</measure>
    <time_frame>Up to 6 months after abnormal FIT result date</time_frame>
    <description>Number of days from abnormal FIT result to the date of completed diagnostic colonoscopy among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of FIT result and diagnostic colonoscopy.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">4400</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Trial Mailed FIT Intervention - Age Group 50-75</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trial Usual Care - Age Group 50-75</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-40</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trial Mailed FIT Intervention - Age Group 50-75</intervention_name>
    <description>Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.</description>
    <arm_group_label>Trial Mailed FIT Intervention - Age Group 50-75</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49</intervention_name>
    <description>Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an enhanced envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The enhanced envelope is a yellow padded envelope with a USPS tracking label and sticker message: &quot;Important information from your doctor&quot;. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.</description>
    <arm_group_label>Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49</intervention_name>
    <description>Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in plain envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The plain envelope is a white envelope without a USPS tracking label or sticker message. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.</description>
    <arm_group_label>Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-40</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 45-75 years&#xD;
&#xD;
          -  At average risk for CRC (&quot;average risk&quot; is defined as those patients who do not have&#xD;
             any of the following: documented history of CRC, colorectal neoplasms, colorectal&#xD;
             polyps, colonic adenomas, family history of CRC among first degree relative [father,&#xD;
             mother, sister, brother], or diagnosis of inflammatory bowel disease)&#xD;
&#xD;
          -  No record of fecal occult blood test (FOBT)/FIT within the past 12 months or&#xD;
             colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5&#xD;
             years, or computed tomography (CT) colonography within 10 years of the EHR query date&#xD;
&#xD;
          -  No record of any CRC diagnosis or total colectomy&#xD;
&#xD;
          -  No record of comorbidities or screening contraindications, including dementia, hospice&#xD;
             care, assisted living, end-stage renal disease, and other cancers (glioblastoma,&#xD;
             pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer,&#xD;
             mesothelioma)&#xD;
&#xD;
          -  Has a complete North Carolina mailing address in the EHR&#xD;
&#xD;
          -  Active patient of the clinic (seen within the past 18 months) at the time of&#xD;
             randomization&#xD;
&#xD;
          -  No record of a positive (abnormal) FIT result in the first study round (Trial Ages&#xD;
             50-75 only)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age younger than 45 years or older than 75 years&#xD;
&#xD;
          -  Not at average risk for CRC (&quot;average risk&quot; is defined as those patients who do not&#xD;
             have any of the following: documented history of CRC, colorectal neoplasms, colorectal&#xD;
             polyps, colonic adenomas, family history of CRC among first degree relative [father,&#xD;
             mother, sister, brother], or diagnosis of inflammatory bowel disease)&#xD;
&#xD;
          -  Record of FOBT/FIT within the past 12 months or colonoscopy within 10 years,&#xD;
             sigmoidoscopy within 5 years, barium enema within 5 years, or CT colonography within&#xD;
             10 years of the EHR query date&#xD;
&#xD;
          -  Record of any CRC diagnosis or total colectomy&#xD;
&#xD;
          -  Record of comorbidities or screening contraindications, including dementia, hospice&#xD;
             care, assisted living, end-stage renal disease, and other cancers (glioblastoma,&#xD;
             pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer,&#xD;
             mesothelioma)&#xD;
&#xD;
          -  Does not have a complete North Carolina mailing address in the EHR&#xD;
&#xD;
          -  Not an active patient of the clinic (not seen within the past 18 months) at the time&#xD;
             of randomization&#xD;
&#xD;
          -  Record of a positive (abnormal) FIT result reported during the first study round&#xD;
             (Trial Ages 50-75)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel S Reuland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roanoke Chowan Community Health Center</name>
      <address>
        <city>Ahoskie</city>
        <state>North Carolina</state>
        <zip>27910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Ridge Health</name>
      <address>
        <city>Hendersonville</city>
        <state>North Carolina</state>
        <zip>28792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://unclineberger.org/patientcare/clinical-trials/</url>
    <description>UNC Lineberger Comprehensive Cancer Center Clinical Trials</description>
  </link>
  <reference>
    <citation>Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening test use--United States, 2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):881-8.</citation>
    <PMID>24196665</PMID>
  </reference>
  <reference>
    <citation>Church TR, Yeazel MW, Jones RM, Kochevar LK, Watt GD, Mongin SJ, Cordes JE, Engelhard D. A randomized trial of direct mailing of fecal occult blood tests to increase colorectal cancer screening. J Natl Cancer Inst. 2004 May 19;96(10):770-80. doi: 10.1093/jnci/djh134.</citation>
    <PMID>15150305</PMID>
  </reference>
  <reference>
    <citation>Daly JM, Levy BT, Merchant ML, Wilbur J. Mailed fecal-immunochemical test for colon cancer screening. J Community Health. 2010 Jun;35(3):235-9. doi: 10.1007/s10900-010-9227-8.</citation>
    <PMID>20127156</PMID>
  </reference>
  <reference>
    <citation>Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1725-32. doi: 10.1001/jamainternmed.2013.9294.</citation>
    <PMID>23921906</PMID>
  </reference>
  <reference>
    <citation>Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Value of patient time invested in the colonoscopy screening process: time requirements for colonoscopy study. Med Decis Making. 2008 Jan-Feb;28(1):56-65. doi: 10.1177/0272989X07309643.</citation>
    <PMID>18263561</PMID>
  </reference>
  <reference>
    <citation>Kempe KL, Shetterly SM, France EK, Levin TR. Automated phone and mail population outreach to promote colorectal cancer screening. Am J Manag Care. 2012 Jul;18(7):370-8.</citation>
    <PMID>22823531</PMID>
  </reference>
  <reference>
    <citation>Levy BT, Daly JM, Xu Y, Ely JW. Mailed fecal immunochemical tests plus educational materials to improve colon cancer screening rates in Iowa Research Network (IRENE) practices. J Am Board Fam Med. 2012 Jan-Feb;25(1):73-82. doi: 10.3122/jabfm.2012.01.110055.</citation>
    <PMID>22218627</PMID>
  </reference>
  <reference>
    <citation>Sabatino SA, Lawrence B, Elder R, Mercer SL, Wilson KM, DeVinney B, Melillo S, Carvalho M, Taplin S, Bastani R, Rimer BK, Vernon SW, Melvin CL, Taylor V, Fernandez M, Glanz K; Community Preventive Services Task Force. Effectiveness of interventions to increase screening for breast, cervical, and colorectal cancers: nine updated systematic reviews for the guide to community preventive services. Am J Prev Med. 2012 Jul;43(1):97-118. doi: 10.1016/j.amepre.2012.04.009.</citation>
    <PMID>22704754</PMID>
  </reference>
  <reference>
    <citation>Siegel RL, Sahar L, Robbins A, Jemal A. Where can colorectal cancer screening interventions have the most impact? Cancer Epidemiol Biomarkers Prev. 2015 Aug;24(8):1151-6. doi: 10.1158/1055-9965.EPI-15-0082. Epub 2015 Jul 8.</citation>
    <PMID>26156973</PMID>
  </reference>
  <reference>
    <citation>US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, Garcia FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989. Erratum In: JAMA. 2016 Aug 2;316(5):545. JAMA. 2017 Jun 6;317(21):2239.</citation>
    <PMID>27304597</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer Screening</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Community Health Centers</keyword>
  <keyword>Implementation Science</keyword>
  <keyword>Patient Navigation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium. Dataset Items in the LDS are defined by the Common Data Elements. There also will be a &quot;public use data set&quot; that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers. In addition, all data that underlie results in publications will be available per Cancer Moonshot Notice of Award.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>The IPD sharing time frame has not been defined at this time.</ipd_time_frame>
    <ipd_access_criteria>There are 2 classes of dataset requests: public use and special. Requests are submitted via the IMS website. Requestors electronically sign and submit necessary forms, including an agreement to acknowledge ACCSIS in publications and presentations. A public use dataset containing common data elements is made available to external researchers by application. IMS responds to public use dataset applications by sending the requestor one-time access to a data download link. External researchers may also request a more customized data set. Requestors must submit a brief concept form or ancillary studies form, for preliminary review by the ACCSIS Steering Committee (SC), before invitation to submit a full proposal. Full proposals receive administrative review by NCI and RTI before being sent to the SC for review and approval. Requestors report every 6 months and published articles or conference presentations to RTI. Requestors are encouraged to make articles available through PubMed Central.</ipd_access_criteria>
  </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/NCT04406714
org study id: LCCC2056
secondary id: 4UH3CA233251-02
nct id: NCT04406714
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will test the effectiveness of mailing fecal immunochemical tests (FITs) in
      increasing colorectal cancer (CRC) screening rates in U.S. adults ages 45-75. We are
      implementing this study in two age groups, 45-49 years and 50-75 years.
Trial (Age Group 50-75) This randomized controlled trial assesses the effectiveness,
      feasibility, acceptability, and cost-effectiveness of mailing FITs from a central location to
      patients served by FQHCs. Subjects are randomly selected and assigned to receive either a
      mailed FIT intervention (Arm 1: Trial Mailed FIT Intervention - Age Group 50-75) or usual
      care (Arm 2: Trial Usual Care - Age Group 50-75). To assess United States Preventive Services
      Task Force recommendations for annual screening, we will mail subjects one round of FIT per
      year for up to two years.

      Sub-study (Age Group 45-49) A sub-study assesses the effectiveness of mailing FITs from a
      central location to patients who are 45-49 years of age and newly eligible for CRC screening.
      The sub-study also assesses the impact of varying the appearance of the FIT packet mailing
      envelope on FIT return. All eligible patients from one FQHC clinic site are randomly assigned
      to receive either a mailed FIT intervention that includes an enhanced mailing envelope (Arm
      3: Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) or a plain envelope
      (Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49).

      The Trial (Age Group 50-75) and the Sub-study (Age Group 45-49) also assess the effectiveness
      of delivering patient navigation from a central location to facilitate follow up colonoscopy
      for patients with a positive (abnormal) FIT result.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Trial (Age Group 50-75) Using a randomized controlled trial study design, subjects are assigned to one of two arms: Arm 1: Trial Mailed FIT Intervention; or Arm 2: Trial Usual Care. Arm 1 (intervention) receives a mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the study (i.e., two annual rounds of mailed FIT).
Sub-study (Age Group 45-49) Subjects, ages 45-49, are randomly assigned to one of two arms: Arm 3: Sub-Study Mailed FIT Intervention - Enhanced Envelope; or Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope. Subjects in both Arm 3 and Arm 4 receive mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the sub-study (i.e., one annual round of mailed FIT).
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Proportion of subjects, ages 50-75, who complete CRC screening within 6 months (Trial - Age Group 50-75)
time frame: 6 months after randomization
description: Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who complete CRC screening using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test [FOBT], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review.
measure: Proportion of subjects who return a completed mailed FIT at 60 days (Trial - Age Group 50-75)
time frame: 60 days after randomization
description: Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) who return a completed FIT per electronic health record review.
measure: Proportion of subjects who complete a follow-up (diagnostic) colonoscopy at 6 months (Trial - Age Group 50-75)
time frame: 6 months after diagnostic colonoscopy result date
description: Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who complete a follow-up (diagnostic) colonoscopy per electronic health record review.
measure: Number of CRCs and advanced adenomas detected at 12 months (Trial - Age Group 50-75)
time frame: 12 months after screening or diagnostic colonoscopy result date
description: Number of CRCs and advanced adenomas detected among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who complete a screening or follow-up (diagnostic) colonoscopy per electronic health record review.
measure: Number of days from CRC diagnosis to the date of evaluation for CRC treatment (Trial - Age Group 50-75)
time frame: Up to 12 months after CRC diagnosis
description: Number of days from CRC diagnosis to the date of evaluation for CRC treatment among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of CRC diagnosis and evaluation for CRC treatment.
measure: Number of subjects who receive referral for cancer treatment (Trial - Age Group 50-75)
time frame: 6 months after cancer diagnosis date
description: Number of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who receive referral for cancer treatment among individuals diagnosed with CRC per electronic health record review.
measure: Number of mailed FITs completed after two rounds of annual FIT outreach (Trial - Age Group 50-75)
time frame: Up to 18 months after randomization
description: Number of mailed FITs completed (0, 1, or 2) by subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) after two rounds of annual FIT outreach, per electronic health record review.
measure: Incremental cost of each additional patient screened in the intervention arm compared to usual care (Trial - Age Group 50-75)
time frame: Through study completion, up to 36 months after randomization
description: Comparison of the programmatic costs incurred and number of subjects screened in Arm 1(Trial Mailed FIT Intervention - Age Group 50-75) compared to Arm 2 (Trial Usual Care - Age Group 50-75), measured as cost of intervention minus the cost of usual care, divided by the number screened in Arm 1 minus the number screened in Arm 2. Intervention costs will be assessed using periodic episodes of direct observation of mailed FIT outreach activities, time logs maintained by the intervention team, and assembly of administrative data capturing non-personnel/non-labor expenditures, such as costs associated with materials printing, FIT processing, and mailing costs. Usual care costs will be assessed using a combination of clinic observations and interviews with staff.
measure: Proportion of subjects, ages 45-49, who are current with CRC screening (Sub-study - Age Group 45-49)
time frame: 6 months after randomization
description: The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who who are current with any CRC screening compared to baseline, using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test [FOBT], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review.
measure: Proportion of subjects, ages 45-49, who completed mailed FIT at 60 days (Sub-study - Age Group 45-49)
time frame: 60 days after randomization
description: The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) compared to subjects in Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who return a completed FIT.
measure: Proportion of subjects who complete a follow-up diagnostic colonoscopy at 60 days (Sub-study - Age Group 45-49)
time frame: 60 days after abnormal FIT result date
description: Proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-40) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who complete a follow-up (diagnostic) colonoscopy per electronic health record review.
measure: Proportion of participants who return a completed mailed FIT at 90 days (exploratory outcome) (Trial Age Group 50-75)
time frame: 90 days after randomization
description: Proportion of participants in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) who return a completed FIT per electronic health record review.
measure: Number of days from abnormal FIT result date to diagnostic colonoscopy (Trial - Age Group 50-75)
time frame: Up to 6 months after abnormal FIT result date
description: Number of days from abnormal FIT result to the date of completed diagnostic colonoscopy among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of FIT result and diagnostic colonoscopy.
arm group label: Trial Mailed FIT Intervention - Age Group 50-75
arm group type: Experimental
description: Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.
arm group label: Trial Usual Care - Age Group 50-75
arm group type: No Intervention
description: Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.
arm group label: Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49
arm group type: Experimental
description: Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.
arm group label: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-40
arm group type: Active Comparator
description: Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.
intervention type: Behavioral
intervention name: Trial Mailed FIT Intervention - Age Group 50-75
description: Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.
arm group label: Trial Mailed FIT Intervention - Age Group 50-75
intervention type: Behavioral
intervention name: Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49
description: Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an enhanced envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The enhanced envelope is a yellow padded envelope with a USPS tracking label and sticker message: "Important information from your doctor". Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.
arm group label: Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49
intervention type: Behavioral
intervention name: Sub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49
description: Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in plain envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The plain envelope is a white envelope without a USPS tracking label or sticker message. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.
arm group label: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-40
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel S Reuland, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
facility: 
country: United States
url: https://unclineberger.org/patientcare/clinical-trials/
description: UNC Lineberger Comprehensive Cancer Center Clinical Trials
citation: Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening test use--United States, 2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):881-8.
PMID: 24196665
citation: Church TR, Yeazel MW, Jones RM, Kochevar LK, Watt GD, Mongin SJ, Cordes JE, Engelhard D. A randomized trial of direct mailing of fecal occult blood tests to increase colorectal cancer screening. J Natl Cancer Inst. 2004 May 19;96(10):770-80. doi: 10.1093/jnci/djh134.
PMID: 15150305
citation: Daly JM, Levy BT, Merchant ML, Wilbur J. Mailed fecal-immunochemical test for colon cancer screening. J Community Health. 2010 Jun;35(3):235-9. doi: 10.1007/s10900-010-9227-8.
PMID: 20127156
citation: Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1725-32. doi: 10.1001/jamainternmed.2013.9294.
PMID: 23921906
citation: Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Value of patient time invested in the colonoscopy screening process: time requirements for colonoscopy study. Med Decis Making. 2008 Jan-Feb;28(1):56-65. doi: 10.1177/0272989X07309643.
PMID: 18263561
citation: Kempe KL, Shetterly SM, France EK, Levin TR. Automated phone and mail population outreach to promote colorectal cancer screening. Am J Manag Care. 2012 Jul;18(7):370-8.
PMID: 22823531
citation: Levy BT, Daly JM, Xu Y, Ely JW. Mailed fecal immunochemical tests plus educational materials to improve colon cancer screening rates in Iowa Research Network (IRENE) practices. J Am Board Fam Med. 2012 Jan-Feb;25(1):73-82. doi: 10.3122/jabfm.2012.01.110055.
PMID: 22218627
citation: Sabatino SA, Lawrence B, Elder R, Mercer SL, Wilson KM, DeVinney B, Melillo S, Carvalho M, Taplin S, Bastani R, Rimer BK, Vernon SW, Melvin CL, Taylor V, Fernandez M, Glanz K; Community Preventive Services Task Force. Effectiveness of interventions to increase screening for breast, cervical, and colorectal cancers: nine updated systematic reviews for the guide to community preventive services. Am J Prev Med. 2012 Jul;43(1):97-118. doi: 10.1016/j.amepre.2012.04.009.
PMID: 22704754
citation: Siegel RL, Sahar L, Robbins A, Jemal A. Where can colorectal cancer screening interventions have the most impact? Cancer Epidemiol Biomarkers Prev. 2015 Aug;24(8):1151-6. doi: 10.1158/1055-9965.EPI-15-0082. Epub 2015 Jul 8.
PMID: 26156973
citation: US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, Garcia FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989. Erratum In: JAMA. 2016 Aug 2;316(5):545. JAMA. 2017 Jun 6;317(21):2239.
PMID: 27304597
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: Yes
ipd description: As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium. Dataset Items in the LDS are defined by the Common Data Elements. There also will be a "public use data set" that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers. In addition, all data that underlie results in publications will be available per Cancer Moonshot Notice of Award.
ipd info type: Study Protocol
ipd time frame: The IPD sharing time frame has not been defined at this time.
ipd access criteria: There are 2 classes of dataset requests: public use and special. Requests are submitted via the IMS website. Requestors electronically sign and submit necessary forms, including an agreement to acknowledge ACCSIS in publications and presentations. A public use dataset containing common data elements is made available to external researchers by application. IMS responds to public use dataset applications by sending the requestor one-time access to a data download link. External researchers may also request a more customized data set. Requestors must submit a brief concept form or ancillary studies form, for preliminary review by the ACCSIS Steering Committee (SC), before invitation to submit a full proposal. Full proposals receive administrative review by NCI and RTI before being sent to the SC for review and approval. Requestors report every 6 months and published articles or conference presentations to RTI. Requestors are encouraged to make articles available through PubMed Central.