<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/NCT03276091</url>
  </required_header>
  <id_info>
    <org_study_id>IDRCB 2017-A00635-48</org_study_id>
    <nct_id>NCT03276091</nct_id>
  </id_info>
  <brief_title>Colonoscopy Motivation for Patients With Positive Immunochemical Fecal Test</brief_title>
  <acronym>Colofit+</acronym>
  <official_title>Evaluation of a Motivational Phone Call Strategy to Improve Colonoscopy Participation, for Patients With a Positive Immunochemical Fecal Test : Colofit + Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Patricia Soler-Michel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association pour le Dépistage Organisé des Cancers dans le Rhône</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around&#xD;
      10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone&#xD;
      call (given by a doctor) to improve colonoscopy participation. And try to understand why this&#xD;
      patients don't want to make this examination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2017</start_date>
  <completion_date type="Actual">March 16, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participation to the colonoscopy</measure>
    <time_frame>From date of phone call until the date of first documented colonoscopy assessed up to 6 months</time_frame>
    <description>Colonoscopy done six months after our phone call</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>reasons for rejecting colonoscopy</measure>
    <time_frame>Reasons for rejecting colonoscopy will be assessed during the phone call only, and assessed until the end of this phone call</time_frame>
    <description>we will ask to patients why they don't realized their colonoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cancer and adenoma detected</measure>
    <time_frame>From date of phone call until the date of first documented colonoscopy result assessed up to 6 months after phone call</time_frame>
    <description>number of cancer and adenoma detected during colonoscopy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>COLOFIT+ Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Personnalized motivational phone call, done by a medical physician</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colofit+ intervention</intervention_name>
    <description>Personnalized phone call, done by the medical student in the name of Adémas-69, organized cancers screening in the Rhône area association. This is a motivational call to encourage patients with an immunochemical fecal test positive, to realized their colonoscopy.</description>
    <arm_group_label>COLOFIT+ Study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  immunochemical fecal test positive but no colonoscopy performed despite a full&#xD;
             sequence of reminder (3 letters)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  colonoscopy done&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>51 Years</minimum_age>
    <maximum_age>77 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thierry Ponchon, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Hopital Edouard Herriot</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ademas-69</name>
      <address>
        <city>Lyon</city>
        <zip>69005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>July 2, 2018</last_update_submitted>
  <last_update_submitted_qc>July 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Association pour le Dépistage Organisé des Cancers dans le Rhône</investigator_affiliation>
    <investigator_full_name>Patricia Soler-Michel</investigator_full_name>
    <investigator_title>ADEMAS69</investigator_title>
  </responsible_party>
  <keyword>colonoscopy</keyword>
  <keyword>immunochemical fecal test</keyword>
  <keyword>screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03276091
org study id: IDRCB 2017-A00635-48
nct id: NCT03276091
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around
      10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone
      call (given by a doctor) to improve colonoscopy participation. And try to understand why this
      patients don't want to make this examination.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Participation to the colonoscopy
time frame: From date of phone call until the date of first documented colonoscopy assessed up to 6 months
description: Colonoscopy done six months after our phone call
measure: reasons for rejecting colonoscopy
time frame: Reasons for rejecting colonoscopy will be assessed during the phone call only, and assessed until the end of this phone call
description: we will ask to patients why they don't realized their colonoscopy
measure: cancer and adenoma detected
time frame: From date of phone call until the date of first documented colonoscopy result assessed up to 6 months after phone call
description: number of cancer and adenoma detected during colonoscopy
arm group label: COLOFIT+ Study
arm group type: Experimental
description: Personnalized motivational phone call, done by a medical physician
intervention type: Behavioral
intervention name: Colofit+ intervention
description: Personnalized phone call, done by the medical student in the name of Adémas-69, organized cancers screening in the Rhône area association. This is a motivational call to encourage patients with an immunochemical fecal test positive, to realized their colonoscopy.
arm group label: COLOFIT+ Study
criteria: 
gender: All
minimum age: 51 Years
maximum age: 77 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thierry Ponchon, PHD
role: Study Director
affiliation: Hopital Edouard Herriot
facility: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Association pour le Dépistage Organisé des Cancers dans le Rhône
investigator full name: Patricia Soler-Michel
investigator title: ADEMAS69
mesh term: Colonic Neoplasms
sharing ipd: No