<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/NCT01688817</url>
  </required_header>
  <id_info>
    <org_study_id>CMKP-2008</org_study_id>
    <nct_id>NCT01688817</nct_id>
  </id_info>
  <brief_title>The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program</brief_title>
  <official_title>The Magnitude of Effect of Physician's Counseling on Participation Rate and Utilization of Sedation in Colonoscopy-based Colorectal Cancer Screening Program</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>
  </sponsors>
  <source>Maria Sklodowska-Curie National Research Institute of Oncology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the impact of physician's counseling on participation&#xD;
      and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening&#xD;
      program&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participation rate is one of the major factors influencing the effectiveness of screening&#xD;
      programs. Participation rates in CRC screening, including primary colonoscopy programs,&#xD;
      remain suboptimal. It is known that one of the strongest predictors of CRC screening&#xD;
      participation rate is a physician, especially primary care physician (PCP), recommendation.&#xD;
      Engaging a PCP tends to improve participation rate in organized and opportunistic cancer&#xD;
      screening programs.&#xD;
&#xD;
      To our best knowledge there are no randomized controlled trials, dedicated specifically to&#xD;
      assess the effect of physician's counseling on participation rate in primary colonoscopy CRC&#xD;
      screening programs. There is also no data on the impact of physician's counseling on&#xD;
      patient's decision to choose unsedated (not in sedation) or sedated colonoscopy.&#xD;
&#xD;
      In this study we aimed to quantitatively estimate the impact of a PCP's counseling on&#xD;
      screening participation rate and utilization of sedation in the opportunistic primary CRC&#xD;
      screening program when compared to the effect obtained by using a standardized information&#xD;
      leaflet only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</start_date>
  <completion_date type="Actual">May 2010</completion_date>
  <primary_completion_date type="Actual">December 2009</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program</measure>
    <time_frame>Six months after intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).</measure>
    <time_frame>Six months after intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Physician's counseling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Information leaflet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physician's counseling</intervention_name>
    <description>Colorectal cancer (CRC) screening was recommended to a patient personally by a PCP. The issue was discussed during a routine medical visit according to a standardized scheme. PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease. A patient was told about colonoscopy-based screening program. A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation. According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them.</description>
    <arm_group_label>Physician's counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information leaflet</intervention_name>
    <description>Patients were given leaflet on primary colonoscopy colorectal cancer screening program. A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program.</description>
    <arm_group_label>Information leaflet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50-65 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  colonoscopy within last 10 years&#xD;
&#xD;
          -  change in bowel habits in the previous six months&#xD;
&#xD;
          -  a visible blood in stool (unless related to known hemorrhoids)&#xD;
&#xD;
          -  anemia or weight loss of unknown cause&#xD;
&#xD;
          -  severe comorbid conditions making subject ineligible for screening colonoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaroslaw Regula, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michal F. Kaminski, 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>Michal Wiszniewski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland</affiliation>
  </overall_official>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Neoplasms</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Early Detection of Cancer</keyword>
  <keyword>Patient Selection</keyword>
  <keyword>Patient Participation</keyword>
  <keyword>Physicians, Primary Care</keyword>
  <keyword>Conscious Sedation</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/NCT01688817
org study id: CMKP-2008
nct id: NCT01688817
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the impact of physician's counseling on participation
      and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening
      program
Participation rate is one of the major factors influencing the effectiveness of screening
      programs. Participation rates in CRC screening, including primary colonoscopy programs,
      remain suboptimal. It is known that one of the strongest predictors of CRC screening
      participation rate is a physician, especially primary care physician (PCP), recommendation.
      Engaging a PCP tends to improve participation rate in organized and opportunistic cancer
      screening programs.

      To our best knowledge there are no randomized controlled trials, dedicated specifically to
      assess the effect of physician's counseling on participation rate in primary colonoscopy CRC
      screening programs. There is also no data on the impact of physician's counseling on
      patient's decision to choose unsedated (not in sedation) or sedated colonoscopy.

      In this study we aimed to quantitatively estimate the impact of a PCP's counseling on
      screening participation rate and utilization of sedation in the opportunistic primary CRC
      screening program when compared to the effect obtained by using a standardized information
      leaflet only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program
time frame: Six months after intervention
measure: Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).
time frame: Six months after intervention
arm group label: Physician's counseling
arm group type: Other
arm group label: Information leaflet
arm group type: Active Comparator
intervention type: Other
intervention name: Physician's counseling
description: Colorectal cancer (CRC) screening was recommended to a patient personally by a PCP. The issue was discussed during a routine medical visit according to a standardized scheme. PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease. A patient was told about colonoscopy-based screening program. A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation. According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them.
arm group label: Physician's counseling
intervention type: Other
intervention name: Information leaflet
description: Patients were given leaflet on primary colonoscopy colorectal cancer screening program. A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program.
arm group label: Information leaflet
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jaroslaw Regula, MD, PhD
role: Study Director
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
last name: Michal F. Kaminski, MD, PhD
role: Study Chair
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
last name: Michal Wiszniewski, MD
role: Principal Investigator
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
responsible party type: Sponsor
mesh term: Colorectal Neoplasms