<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/NCT02188927</url>
  </required_header>
  <id_info>
    <org_study_id>TEAM/2012-9/5</org_study_id>
    <nct_id>NCT02188927</nct_id>
  </id_info>
  <brief_title>Effect of an Advanced Notification Letter on Screening Colonoscopy Participation</brief_title>
  <official_title>Participation in Screening Colonoscopy in Response to an Advanced Notification Letter Plus Standard Invitation Versus Standard Invitation Only - a Population-based Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maria Sklodowska-Curie National Research Institute of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre of Postgraduate Medical Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Union</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maria Sklodowska-Curie National Research Institute of Oncology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participation in a primary screening colonoscopy programs remains low. Advanced notification&#xD;
      letter has been shown to increase participation in colorectal cancer screening with fecal&#xD;
      occult blood testing and to be cost effective compared to standard invitation. It is unknown&#xD;
      whether advanced notification letter increases participation rate in primary colonoscopy&#xD;
      screening program.&#xD;
&#xD;
      We hypothesize that an Advance Notification Letter will have significant influence on&#xD;
      participation in screening colonoscopy, comparing to standard invitation procedure and will&#xD;
      thus result in higher efficiency of the program.&#xD;
&#xD;
      This randomized controlled study aims to compare the participation rate in screening&#xD;
      colonoscopy in response to advanced notification plus standard invitation letter and standard&#xD;
      invitation letter alone.&#xD;
&#xD;
      Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population&#xD;
      Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy&#xD;
      with advanced notification letter (send two weeks before standard invitation) plus standard&#xD;
      invitation (send six weeks before planned screening colonoscopy) or to standard invitation&#xD;
      only (send six weeks before planned screening colonoscopy). The sample size was calculated to&#xD;
      detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participation rate</measure>
    <time_frame>three months after receiving invitation</time_frame>
    <description>A percentage of invitees who undergo the screening colonoscopy. The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>three months after receiving invitation</time_frame>
    <description>Estimation of the invitees' response rate to Standard Invitation and Advanced Notification Letter followed by Standard Invitation, before receiving Reminding Letter.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost of including Advance Notification Letter</measure>
    <time_frame>1 year</time_frame>
    <description>Total cost of including Advanced notification letter into the standard invitation procedure of this study group.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">6800</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Adenoma</condition>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Implementation of ANL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Procedure : Implementation of routine Advanced Notification Letter included in Standard Invitation procedure&#xD;
Advanced Notification Letter will be implemented in invitation procedure and send two weeks before Standard Invitation (Standard Invitation will be send six weeks before planned screening colonoscopy)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No included ANL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Implementation of ANL</intervention_name>
    <description>Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy</description>
    <arm_group_label>Implementation of ANL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No included ANL</intervention_name>
    <description>Sending Standard Invitation only six weeks before planned screening colonoscopy</description>
    <arm_group_label>No included ANL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all individuals aged 55-64 years living in the counties covered with the organized CRC&#xD;
             screening program and assigned to invitation to screening colonoscopy in the year 2014&#xD;
             are eligible for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  message from neighbor/family/post office on death of screenee (not updated in&#xD;
             Population Registry)&#xD;
&#xD;
          -  resident abroad (not updated in Population Registry)&#xD;
&#xD;
          -  return of unopened letter of invitation and/or reminder (address unknown)&#xD;
&#xD;
          -  diagnosis of CRC before the date of draw (not updated in the National Cancer Registry)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karolina Janikowska, MD,MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaroslaw Regula, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bartlomiej Kocot</last_name>
    <role>Study Director</role>
    <affiliation>The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland</name>
      <address>
        <city>Warsaw</city>
        <state>Mazovian</state>
        <country>Poland</country>
      </address>
    </facility>
    <contact>
      <last_name>Karolina Janikowska, MD, MSc</last_name>
      <phone>22 546 30 58</phone>
      <phone_ext>+48</phone_ext>
      <email>kjanikowska@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced notification letter</keyword>
  <keyword>Standard invitation</keyword>
  <keyword>Participation rate</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Screening</keyword>
  <keyword>Colorectal Neoplasms</keyword>
  <keyword>Digestive System Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT02188927
org study id: TEAM/2012-9/5
nct id: NCT02188927
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Participation in a primary screening colonoscopy programs remains low. Advanced notification
      letter has been shown to increase participation in colorectal cancer screening with fecal
      occult blood testing and to be cost effective compared to standard invitation. It is unknown
      whether advanced notification letter increases participation rate in primary colonoscopy
      screening program.

      We hypothesize that an Advance Notification Letter will have significant influence on
      participation in screening colonoscopy, comparing to standard invitation procedure and will
      thus result in higher efficiency of the program.

      This randomized controlled study aims to compare the participation rate in screening
      colonoscopy in response to advanced notification plus standard invitation letter and standard
      invitation letter alone.

      Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population
      Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy
      with advanced notification letter (send two weeks before standard invitation) plus standard
      invitation (send six weeks before planned screening colonoscopy) or to standard invitation
      only (send six weeks before planned screening colonoscopy). The sample size was calculated to
      detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Participation rate
time frame: three months after receiving invitation
description: A percentage of invitees who undergo the screening colonoscopy. The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.
measure: Response rate
time frame: three months after receiving invitation
description: Estimation of the invitees' response rate to Standard Invitation and Advanced Notification Letter followed by Standard Invitation, before receiving Reminding Letter.
measure: Cost of including Advance Notification Letter
time frame: 1 year
description: Total cost of including Advanced notification letter into the standard invitation procedure of this study group.
arm group label: Implementation of ANL
arm group type: Experimental
description: Intervention: Procedure : Implementation of routine Advanced Notification Letter included in Standard Invitation procedure
Advanced Notification Letter will be implemented in invitation procedure and send two weeks before Standard Invitation (Standard Invitation will be send six weeks before planned screening colonoscopy)
arm group label: No included ANL
arm group type: Active Comparator
description: Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy
intervention type: Other
intervention name: Implementation of ANL
description: Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy
arm group label: Implementation of ANL
intervention type: Behavioral
intervention name: No included ANL
description: Sending Standard Invitation only six weeks before planned screening colonoscopy
arm group label: No included ANL
criteria: 
gender: All
minimum age: 55 Years
maximum age: 64 Years
healthy volunteers: No
last name: Karolina Janikowska, MD,MSc
role: Principal Investigator
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
last name: Jaroslaw Regula, MD, PhD
role: Study Chair
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
last name: Bartlomiej Kocot
role: Study Director
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
facility: 
contact: 
country: Poland
responsible party type: Sponsor
mesh term: Adenoma