<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/NCT04492215</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC19.0115 (AMDepCCR)</org_study_id>
    <secondary_id>2019-A01776-51</secondary_id>
    <nct_id>NCT04492215</nct_id>
  </id_info>
  <brief_title>General Practitioners and Participation Rate in ColoRectal Cancer Screening</brief_title>
  <acronym>AMDepCCR</acronym>
  <official_title>Improving the Participation Rate in ColoRectal Cancer Screening by Training General Practitioners in Motivational Interviewing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Colorectal cancer is the 2nd leading cause of cancer mortality in France. However this cancer&#xD;
      is preventable in the majority of cases by early detection of adenomas.&#xD;
&#xD;
      In France, there is organized colorectal cancer screening, which relies on general&#xD;
      practitioners (GPs). Tests delivered by GPs are performed in 89% of cases. However, GPs do&#xD;
      not systematically offer the test, for time management and communication reasons. Patients&#xD;
      expect their GPs to offer the test and to focus on their expectations. A previous study&#xD;
      conducted on GPs showed that training in communication and motivational interviewing&#xD;
      increases the number of tests performed by 12.2%.&#xD;
&#xD;
      In order to facilitate the promotion of screening, the investigators would like to develop a&#xD;
      training programme for GPs focusing on the application of Motivational Interviewing (MI)&#xD;
      techniques to the promotion of colorectal cancer screening.&#xD;
&#xD;
      Motivational Interviewing is a directive, client-centered counseling style for eliciting&#xD;
      behavior change by helping clients to explore and resolve ambivalence.&#xD;
&#xD;
      This study is a multicenter trial in general medicine. In this randomized trial the 902&#xD;
      subjects will be included prospectively by the general practitioners (GP) participating in&#xD;
      the study.&#xD;
&#xD;
      As a first step, general practitioners who have never participated in Motivational&#xD;
      Interviewing training will be recruited and split into 2 groups by randomization, an&#xD;
      intervention group and a control group. The interventional group will then undergo a 3 times&#xD;
      2-day training in Motivational Interviewing.&#xD;
&#xD;
      In a second step, the patients will be included by those GP and a self-questionnaire will be&#xD;
      send at the inclusion and after 6, 12 and 24 months. The evaluation of the number of tests&#xD;
      performed and the analyse of the Health Belief Model (HBM) self-questionnaire will be carried&#xD;
      out.&#xD;
&#xD;
      At 24 months, there will be an evaluation of the denial motivation questionnaire for patients&#xD;
      who have not participated in organized colorectal cancer screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 31, 2021</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 31, 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>This study is a multicenter trial. Patients will be followed either by GPs from the interventional group who participated in motivational interviewing or by the control group who never participated. The distribution of general practitioners in the groups is done thanks random draw.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The study is based on the participation of general practitioners in a training, the test is necessarily open for doctors. However patients will not know if their doctor has received training and will be blinded..</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of organised colorectal cancer screening at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>The impact of training general practitioners in motivational interviewing on the rate of organised colorectal cancer screening will be assessed by determining whether or not the immunological test proposed as part of organised colorectal cancer screening at 24 months will be carried out.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of organised colorectal cancer screening at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Whether or not to perform the proposed immunological test as part of organized colorectal cancer screening at 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in perceptions of colorectal cancer screening</measure>
    <time_frame>Day 0, 6 months, 12 months and 24 months</time_frame>
    <description>Changes in perceptions of colorectal cancer screening will be assessed using a Health Belief Model (HBM). The Health Belief Model (HBM) is a social psychological health behavior change model developed to explain and predict health-related behaviors, particularly in regard to the uptake of health services.&#xD;
This Health Belief Model use for this study evaluate : individual perceptions (perceived susceptibility and severity), modifying factors (perceived threat and cues to action) and likelihood of action (perceived benefit and perception barriers and taking health action) at Day 0, Month 6, Month 12 and Month 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the self-assessment of life expectancy</measure>
    <time_frame>Day 0, 6 months, 12 months and 24 months</time_frame>
    <description>Patients will answer a question to find out their self-assessment of life expectancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of denial of the colorectal cancer screening</measure>
    <time_frame>24 months</time_frame>
    <description>Understand why patients refuse colorectal cancer screening of by identificating et quantificating reasons why the patient did not realised the colorectal cancer screening at 24 months of follow up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">902</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Physicians trained in motivational interviewing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients followed by general practitioners trained in motivational interviewing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physicians did not trainned in motivational interviewing</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients followed by general practitioners who did not receive motivational interviewing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interaction between patient and trained general practitioners in motivational interviewing</intervention_name>
    <description>Impact of the medical interview on the patient</description>
    <arm_group_label>Physicians trained in motivational interviewing</arm_group_label>
    <other_name>Experimental arm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People with an average risk of colorectal cancer (presenting no symptoms or risk&#xD;
             factors).&#xD;
&#xD;
          -  People living in Finistère.&#xD;
&#xD;
          -  People aged 50 to 74 who have never participated in organized screening for colorectal&#xD;
             cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons without address to receive the Health Belief Model (HBM)questionnaire&#xD;
&#xD;
          -  People who do not fit the organized screening criteria&#xD;
&#xD;
          -  Persons unable to give consent (patients under guardianship, curatorship, non-French&#xD;
             speaking, illiterate)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jean Yves Le Reste, Pr</last_name>
    <phone>02 98 01 65 52</phone>
    <phone_ext>+33</phone_ext>
    <email>lereste@univ-brest.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dr ABALAIN</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aurélie ABALAIN, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr HENRY</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre HENRY, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr PETTON-HILI</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne-Laure PETTON-HILI, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr DENIEL</name>
      <address>
        <city>Châteauneuf-du-Faou</city>
        <zip>29520</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Magalie DENIEL, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr LE BOURHIS</name>
      <address>
        <city>Châteauneuf-du-Faou</city>
        <zip>29520</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Erwan LE BOURHIS, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr PERRIER</name>
      <address>
        <city>Clohars-Carnoët</city>
        <zip>29360</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Isabelle Clohars-Carnoët, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr CHAPOIX</name>
      <address>
        <city>Crozon</city>
        <zip>29160</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nicolas CHAPOIX, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr OLIVIER</name>
      <address>
        <city>Daoulas</city>
        <zip>29460</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Eric OLIVIER, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr ATTENCOURT</name>
      <address>
        <city>Douarnenez</city>
        <zip>29100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christophe ATTENCOURT, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr KERVELLA</name>
      <address>
        <city>Douarnenez</city>
        <zip>29100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sylvie KERVELLA, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr VELLY</name>
      <address>
        <city>Ergué-Gabéric</city>
        <zip>29500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-François VELLY, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr BLANCHARD</name>
      <address>
        <city>Esquibien</city>
        <zip>29770</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Julie BLANCHARD, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr DESNOT</name>
      <address>
        <city>Esquibien</city>
        <zip>29770</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Richard DESNOT, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr VIALA</name>
      <address>
        <city>Esquibien</city>
        <zip>29770</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jeanlin VIALA, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr DAOUDAL</name>
      <address>
        <city>Fouesnant</city>
        <zip>29170</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aurore DAOUDAL, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr LEFEVRE</name>
      <address>
        <city>Fouesnant</city>
        <zip>29170</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Maxime LEFEVRE, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr MAGADUR</name>
      <address>
        <city>Fouesnant</city>
        <zip>29170</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Véronique MAGADUR, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr MUNCK</name>
      <address>
        <city>Guerlesquin</city>
        <zip>29650</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pauline MUNCK, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr POINOT</name>
      <address>
        <city>Guerlesquin</city>
        <zip>29650</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne POINOT, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr LE FLOCH</name>
      <address>
        <city>Guilvinec</city>
        <zip>29730</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bernard LE FLOCH, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr LE GRIGNOU</name>
      <address>
        <city>Guisseny</city>
        <zip>29880</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Caroline LE GRIGNOU, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr PITMAN</name>
      <address>
        <city>Landivisiau</city>
        <zip>29400</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Roberto PITMAN, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr COLLETER</name>
      <address>
        <city>Lanmeur</city>
        <zip>29260</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Manuel COLLETER, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr CRENN-CORVEZ</name>
      <address>
        <city>Lanmeur</city>
        <zip>29260</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hélène CRENN-CORVEZ, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr BECK-ROBERT</name>
      <address>
        <city>Lanmeur</city>
        <zip>29620</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Emilie BECK-ROBERT, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr BARAIS</name>
      <address>
        <city>Lannilis</city>
        <zip>29870</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marie BARAIS, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr VERBEQUE MORVAN</name>
      <address>
        <city>Le Conquet</city>
        <zip>29217</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Manon VERBEQUE MORVAN, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr TREBAOL</name>
      <address>
        <city>Le Faou</city>
        <zip>29590</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Emmanuelle TREBAOL, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr GRALL</name>
      <address>
        <city>Le Relecq-Kerhuon</city>
        <zip>29480</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Olivier GRALL, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr BOUTERAON</name>
      <address>
        <city>Loperhet</city>
        <zip>29470</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sylvie BOUTERAON, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr PIPET-PENIN</name>
      <address>
        <city>Moelan Sur Mer</city>
        <zip>29350</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gaëlle PIPET-PENIN, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr BEURTON-COURAUD</name>
      <address>
        <city>Pleyben</city>
        <zip>29190</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lucas BEURTON-COURAUD, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr LUCAS</name>
      <address>
        <city>Pleyben</city>
        <zip>29190</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aldric LUCAS, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr KERFRIDEN KERHOAS</name>
      <address>
        <city>Pleyber-Christ</city>
        <zip>29410</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Morgane KERFRIDEN KERHOAS, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr BAUTA</name>
      <address>
        <city>Plonévez-Porzay</city>
        <zip>29550</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Vincent BAUTA, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr COGNEAU</name>
      <address>
        <city>Plonévez-Porzay</city>
        <zip>29550</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Clément COGNEAU, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr GASNIER</name>
      <address>
        <city>Ploudalmezeau</city>
        <zip>29830</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne-Laure GASNIER, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr AOUDIA</name>
      <address>
        <city>Plouezoc'h</city>
        <zip>29252</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Seddik AOUDIA, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr LOPIN</name>
      <address>
        <city>Plougonven</city>
        <zip>29640</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Céline LOPIN, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr DROGOU</name>
      <address>
        <city>Plouhinec</city>
        <zip>29780</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marine DROGOU, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr BODIN</name>
      <address>
        <city>Plouneour Trez</city>
        <zip>29890</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bénédicte BODIN, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr DE LA SOUDIERE</name>
      <address>
        <city>Plouzané</city>
        <zip>29280</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ségolène DE LA SOUDIERE, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr PETIT</name>
      <address>
        <city>Pont l'Abbé</city>
        <zip>29120</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Elisabeth PETIT, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr PREVOT</name>
      <address>
        <city>Pouldreuzic</city>
        <zip>29710</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jeanne PREVOT, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr AUTRET</name>
      <address>
        <city>Quimper</city>
        <zip>29000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hervé AUTRET, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr COROLLER</name>
      <address>
        <city>Quimper</city>
        <zip>29000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Philippe COROLLER, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr COUTURIER</name>
      <address>
        <city>Quimper</city>
        <zip>29000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Thomas COUTURIER, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr JOLIVET COUTURE</name>
      <address>
        <city>Quimper</city>
        <zip>29000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne JOLIVET COUTURE, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr KERGASTEL</name>
      <address>
        <city>Quimper</city>
        <zip>29000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hélène KERGASTEL, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr BARCELO</name>
      <address>
        <city>Saint-Martin-des-Champs</city>
        <zip>29600</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Luc BARCELO, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr MAILLEUCHET</name>
      <address>
        <city>Spezet</city>
        <zip>29540</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-François MAILLEUCHET, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr MONFORT</name>
      <address>
        <city>St Yvi</city>
        <zip>29140</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xavier MONFORT, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr NICOLAS</name>
      <address>
        <city>Trégunc</city>
        <zip>29910</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne-Catherine NICOLAS, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal cancer</keyword>
  <keyword>General practitioners</keyword>
  <keyword>Motivational interviewing</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>All collected data that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available beginning 42 months ending fifteen years following the final study report completion.</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.</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/NCT04492215
org study id: 29BRC19.0115 (AMDepCCR)
secondary id: 2019-A01776-51
nct id: NCT04492215
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer is the 2nd leading cause of cancer mortality in France. However this cancer
      is preventable in the majority of cases by early detection of adenomas.

      In France, there is organized colorectal cancer screening, which relies on general
      practitioners (GPs). Tests delivered by GPs are performed in 89% of cases. However, GPs do
      not systematically offer the test, for time management and communication reasons. Patients
      expect their GPs to offer the test and to focus on their expectations. A previous study
      conducted on GPs showed that training in communication and motivational interviewing
      increases the number of tests performed by 12.2%.

      In order to facilitate the promotion of screening, the investigators would like to develop a
      training programme for GPs focusing on the application of Motivational Interviewing (MI)
      techniques to the promotion of colorectal cancer screening.

      Motivational Interviewing is a directive, client-centered counseling style for eliciting
      behavior change by helping clients to explore and resolve ambivalence.

      This study is a multicenter trial in general medicine. In this randomized trial the 902
      subjects will be included prospectively by the general practitioners (GP) participating in
      the study.

      As a first step, general practitioners who have never participated in Motivational
      Interviewing training will be recruited and split into 2 groups by randomization, an
      intervention group and a control group. The interventional group will then undergo a 3 times
      2-day training in Motivational Interviewing.

      In a second step, the patients will be included by those GP and a self-questionnaire will be
      send at the inclusion and after 6, 12 and 24 months. The evaluation of the number of tests
      performed and the analyse of the Health Belief Model (HBM) self-questionnaire will be carried
      out.

      At 24 months, there will be an evaluation of the denial motivation questionnaire for patients
      who have not participated in organized colorectal cancer screening.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a multicenter trial. Patients will be followed either by GPs from the interventional group who participated in motivational interviewing or by the control group who never participated. The distribution of general practitioners in the groups is done thanks random draw.
primary purpose: Diagnostic
masking: Single (Participant)
masking description: The study is based on the participation of general practitioners in a training, the test is necessarily open for doctors. However patients will not know if their doctor has received training and will be blinded..
measure: Rate of organised colorectal cancer screening at 24 months
time frame: 24 months
description: The impact of training general practitioners in motivational interviewing on the rate of organised colorectal cancer screening will be assessed by determining whether or not the immunological test proposed as part of organised colorectal cancer screening at 24 months will be carried out.
measure: Rate of organised colorectal cancer screening at 12 months
time frame: 12 months
description: Whether or not to perform the proposed immunological test as part of organized colorectal cancer screening at 12 months.
measure: Changes in perceptions of colorectal cancer screening
time frame: Day 0, 6 months, 12 months and 24 months
description: Changes in perceptions of colorectal cancer screening will be assessed using a Health Belief Model (HBM). The Health Belief Model (HBM) is a social psychological health behavior change model developed to explain and predict health-related behaviors, particularly in regard to the uptake of health services.
This Health Belief Model use for this study evaluate : individual perceptions (perceived susceptibility and severity), modifying factors (perceived threat and cues to action) and likelihood of action (perceived benefit and perception barriers and taking health action) at Day 0, Month 6, Month 12 and Month 24.
measure: Evolution of the self-assessment of life expectancy
time frame: Day 0, 6 months, 12 months and 24 months
description: Patients will answer a question to find out their self-assessment of life expectancy.
measure: Identification of denial of the colorectal cancer screening
time frame: 24 months
description: Understand why patients refuse colorectal cancer screening of by identificating et quantificating reasons why the patient did not realised the colorectal cancer screening at 24 months of follow up.
arm group label: Physicians trained in motivational interviewing
arm group type: Experimental
description: Patients followed by general practitioners trained in motivational interviewing
arm group label: Physicians did not trainned in motivational interviewing
arm group type: No Intervention
description: Patients followed by general practitioners who did not receive motivational interviewing.
intervention type: Behavioral
intervention name: Interaction between patient and trained general practitioners in motivational interviewing
description: Impact of the medical interview on the patient
arm group label: Physicians trained in motivational interviewing
other name: Experimental arm
criteria: 
gender: All
minimum age: 50 Years
maximum age: 74 Years
healthy volunteers: No
last name: Jean Yves Le Reste, Pr
phone: 02 98 01 65 52
phone ext: +33
email: lereste@univ-brest.fr
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country: France
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: Yes
ipd description: All collected data that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: Data will be available beginning 42 months ending fifteen years following the final study report completion.
ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.