<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/NCT01710215</url>
  </required_header>
  <id_info>
    <org_study_id>102011-069</org_study_id>
    <secondary_id>1U54CA163308-01</secondary_id>
    <nct_id>NCT01710215</nct_id>
    <nct_alias>NCT03404973</nct_alias>
  </id_info>
  <brief_title>Comparative Effectiveness of FIT, Colonoscopy, &amp; Usual Care Screening Strategies</brief_title>
  <official_title>Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, &amp; Usual Care Screening Strategies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Parkland Health and Hospital System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death&#xD;
      can be reduced by screening. However, there is uncertainty as to which screening strategy is&#xD;
      most clinically and cost-effective from a population perspective where the aim is to optimize&#xD;
      completion of the entire screening process continuum. Modeling studies suggest benefits and&#xD;
      harms of colonoscopy and stool blood test strategies are similar, but generally assume 100%&#xD;
      participation and subsequent clinically appropriate follow up--something never achieved in&#xD;
      clinical practice. Comparative effectiveness studies of testing strategies, including&#xD;
      comparisons of specific tests and approaches to optimizing effective test use, are necessary.&#xD;
      Safety-net health systems care for populations at increased risk for adverse CRC outcomes,&#xD;
      such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets&#xD;
      must resolve the uncertainty regarding the most effective screening strategy. The&#xD;
      investigators will conduct a system-level, randomized comparative effectiveness trial of the&#xD;
      benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age&#xD;
      50-64 years, who are not up-to-date with CRC screening, served by a large safety net health&#xD;
      system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual&#xD;
      mailed invitation outreach (including a test kit), and a centralized process to promote&#xD;
      participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed&#xD;
      invitation outreach, and a centralized process to promote participation and complete clinical&#xD;
      follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at&#xD;
      primary care visits. The primary measure of benefit will be an outcome measure that&#xD;
      summarizes patient-specific effective screening successes. The primary measure of harm will&#xD;
      be screening non-participation. The primary measure of cost will be cost per-patient&#xD;
      effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a&#xD;
      FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with&#xD;
      screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care&#xD;
      and b) the Colo strategy vs. Usual Care for CRC screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Benefit: Proportion of patients achieving one of the effective screening &quot;successes.&quot;</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>The primary benefit measure will be defined by the proportion of patients achieving an effective screening &quot;success&quot; defined as:&#xD;
Invited to colonoscopy (i.e. colo), responded to invite, determined to be too sick to scope by phone triage and clinical review&#xD;
Screening colo completed, no cancer detected&#xD;
Screening colo completed, cancer detected, 1st cancer treatment consultation visit completed&#xD;
FIT screening completed, test normal, FIT repeated annually for 2 years&#xD;
FIT screening completed, test abnormal, failed phone triage for direct scheduling for colo, and after GI clinic visit, determined to be too sick to scope&#xD;
FIT screening completed, test abnormal, failed phone triage and clinical review, GI clinic visit, determined to be scopable, colo completed&#xD;
FIT screening completed, test abnormal, colo completed, no cancer detected&#xD;
FIT screening completed, test abnormal, colo completed, cancer detected, 1st cancer treatment consultation visit completed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Harm: Rate of screening non-participation.</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>The primary measure of harms will be the rate of non-screening because initial test completion is a basic prerequisite for prevention of adverse CRC outcomes by a screening process. It is a readily measurable, basic quality assessment. Processes associated with high rates of non-screening would be expected to result in poor long term CRC outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cost: Cost per-patient effectively screened.</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>The primary measure of costs will be the cost per-patient effectively screened from the health system perspective, with effective screening defined by the proportion of patients achieving an effective screening &quot;success.&quot; Follow up time for cost-assessment will start at randomization and end either when a patient reaches an effective screening &quot;success&quot; endpoint, or at the end of the three year-follow up time. This outcome addresses a practical question most health systems will have in assessing our screening strategy: What is the strategy specific cost per-patient effectively screened?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Benefit: Number of CRCs, advanced adenomas, and adenomas detected.</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>Number of CRCs, advanced adenomas, and adenomas detected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benefit: Number of patients screened.</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>Number of patients screened, defined by the proportion of patients completing one time FIT or colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harm: Number of CRCs diagnosed based on symptoms/signs rather than screening.</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>Number of CRCs diagnosed based on symptoms/signs rather than screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harm: Ineffective screening.</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>Not achieving an effective screening &quot;success.&quot; See definition of effective screening &quot;successes&quot; above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harm: Post-colonoscopy bleeding or perforation.</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>Post-colonoscopy bleeding or perforation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harm: Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost: Cost per patient screened.</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>Cost per patient screened.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost: Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.</measure>
    <time_frame>All outcomes will be adjudicated within 3 years.</time_frame>
    <description>Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">5999</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No outreach mailed invitations.&#xD;
Ordering of colonoscopy or FIT for screening at the discretion of the primary provider.&#xD;
Follow up of abnormal tests and results reporting to the patient at the discretion of primary and specialty providers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FIT Screening Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).&#xD;
Two &quot;live&quot; phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.&#xD;
Centralized processes to promote guideline-based follow up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colon Screening Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.&#xD;
Two &quot;live&quot; phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.&#xD;
Centralized processes to promote guideline-based follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FIT Screening Strategy</intervention_name>
    <description>Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).&#xD;
Two &quot;live&quot; phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.&#xD;
Centralized processes to promote guideline-based follow up.</description>
    <arm_group_label>FIT Screening Strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Colon Screening Strategy</intervention_name>
    <description>Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.&#xD;
Two &quot;live&quot; phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.&#xD;
Centralized processes to promote guideline-based follow up.</description>
    <arm_group_label>Colon Screening Strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females&#xD;
&#xD;
          -  Age 50-64 years&#xD;
&#xD;
          -  Seen one or more times at a Parkland primary care clinic within one year (Index Year)&#xD;
&#xD;
          -  Participants in Parkland's medical assistance program for the uninsured (Parkland&#xD;
             Health Plus)&#xD;
&#xD;
          -  All races and ethnicities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Up-to-date with CRC screening, defined by:&#xD;
&#xD;
               1. Colonoscopy in the last 10 years&#xD;
&#xD;
               2. Sigmoidoscopy in the last 5 years&#xD;
&#xD;
               3. Stool blood test (FIT) in the last year&#xD;
&#xD;
          -  Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps&#xD;
&#xD;
          -  Address or phone number not on file&#xD;
&#xD;
          -  Incarcerated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amit Singal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkland Health &amp; Hospital System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>April 25, 2018</last_update_submitted>
  <last_update_submitted_qc>April 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Neoplasms</keyword>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Colon Cancer</keyword>
  <keyword>Mass Screening</keyword>
  <keyword>Health Services Research</keyword>
  <keyword>Comparative Effectiveness Research</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/NCT01710215
org study id: 102011-069
secondary id: 1U54CA163308-01
nct id: NCT01710215
nct alias: NCT03404973
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death
      can be reduced by screening. However, there is uncertainty as to which screening strategy is
      most clinically and cost-effective from a population perspective where the aim is to optimize
      completion of the entire screening process continuum. Modeling studies suggest benefits and
      harms of colonoscopy and stool blood test strategies are similar, but generally assume 100%
      participation and subsequent clinically appropriate follow up--something never achieved in
      clinical practice. Comparative effectiveness studies of testing strategies, including
      comparisons of specific tests and approaches to optimizing effective test use, are necessary.
      Safety-net health systems care for populations at increased risk for adverse CRC outcomes,
      such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets
      must resolve the uncertainty regarding the most effective screening strategy. The
      investigators will conduct a system-level, randomized comparative effectiveness trial of the
      benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age
      50-64 years, who are not up-to-date with CRC screening, served by a large safety net health
      system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual
      mailed invitation outreach (including a test kit), and a centralized process to promote
      participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed
      invitation outreach, and a centralized process to promote participation and complete clinical
      follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at
      primary care visits. The primary measure of benefit will be an outcome measure that
      summarizes patient-specific effective screening successes. The primary measure of harm will
      be screening non-participation. The primary measure of cost will be cost per-patient
      effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a
      FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with
      screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care
      and b) the Colo strategy vs. Usual Care for CRC screening.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: Benefit: Proportion of patients achieving one of the effective screening "successes."
time frame: All outcomes will be adjudicated within 3 years.
description: The primary benefit measure will be defined by the proportion of patients achieving an effective screening "success" defined as:
Invited to colonoscopy (i.e. colo), responded to invite, determined to be too sick to scope by phone triage and clinical review
Screening colo completed, no cancer detected
Screening colo completed, cancer detected, 1st cancer treatment consultation visit completed
FIT screening completed, test normal, FIT repeated annually for 2 years
FIT screening completed, test abnormal, failed phone triage for direct scheduling for colo, and after GI clinic visit, determined to be too sick to scope
FIT screening completed, test abnormal, failed phone triage and clinical review, GI clinic visit, determined to be scopable, colo completed
FIT screening completed, test abnormal, colo completed, no cancer detected
FIT screening completed, test abnormal, colo completed, cancer detected, 1st cancer treatment consultation visit completed
measure: Harm: Rate of screening non-participation.
time frame: All outcomes will be adjudicated within 3 years.
description: The primary measure of harms will be the rate of non-screening because initial test completion is a basic prerequisite for prevention of adverse CRC outcomes by a screening process. It is a readily measurable, basic quality assessment. Processes associated with high rates of non-screening would be expected to result in poor long term CRC outcomes.
measure: Cost: Cost per-patient effectively screened.
time frame: All outcomes will be adjudicated within 3 years.
description: The primary measure of costs will be the cost per-patient effectively screened from the health system perspective, with effective screening defined by the proportion of patients achieving an effective screening "success." Follow up time for cost-assessment will start at randomization and end either when a patient reaches an effective screening "success" endpoint, or at the end of the three year-follow up time. This outcome addresses a practical question most health systems will have in assessing our screening strategy: What is the strategy specific cost per-patient effectively screened?
measure: Benefit: Number of CRCs, advanced adenomas, and adenomas detected.
time frame: All outcomes will be adjudicated within 3 years.
description: Number of CRCs, advanced adenomas, and adenomas detected.
measure: Benefit: Number of patients screened.
time frame: All outcomes will be adjudicated within 3 years.
description: Number of patients screened, defined by the proportion of patients completing one time FIT or colonoscopy.
measure: Harm: Number of CRCs diagnosed based on symptoms/signs rather than screening.
time frame: All outcomes will be adjudicated within 3 years.
description: Number of CRCs diagnosed based on symptoms/signs rather than screening.
measure: Harm: Ineffective screening.
time frame: All outcomes will be adjudicated within 3 years.
description: Not achieving an effective screening "success." See definition of effective screening "successes" above.
measure: Harm: Post-colonoscopy bleeding or perforation.
time frame: All outcomes will be adjudicated within 3 years.
description: Post-colonoscopy bleeding or perforation.
measure: Harm: Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.
time frame: All outcomes will be adjudicated within 3 years.
description: Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.
measure: Cost: Cost per patient screened.
time frame: All outcomes will be adjudicated within 3 years.
description: Cost per patient screened.
measure: Cost: Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.
time frame: All outcomes will be adjudicated within 3 years.
description: Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.
arm group label: Usual Care
arm group type: No Intervention
description: No outreach mailed invitations.
Ordering of colonoscopy or FIT for screening at the discretion of the primary provider.
Follow up of abnormal tests and results reporting to the patient at the discretion of primary and specialty providers.
arm group label: FIT Screening Strategy
arm group type: Experimental
description: Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).
Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.
Centralized processes to promote guideline-based follow up.
arm group label: Colon Screening Strategy
arm group type: Experimental
description: Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.
Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.
Centralized processes to promote guideline-based follow up.
intervention type: Other
intervention name: FIT Screening Strategy
description: Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).
Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.
Centralized processes to promote guideline-based follow up.
arm group label: FIT Screening Strategy
intervention type: Other
intervention name: Colon Screening Strategy
description: Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.
Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.
Centralized processes to promote guideline-based follow up.
arm group label: Colon Screening Strategy
criteria: 
gender: All
minimum age: 50 Years
maximum age: 64 Years
healthy volunteers: No
last name: Amit Singal, MD
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms