<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/NCT03271476</url>
  </required_header>
  <id_info>
    <org_study_id>2017-01-CHRMT</org_study_id>
    <nct_id>NCT03271476</nct_id>
  </id_info>
  <brief_title>EMDR Psychotherapy to Treat Anxious-depressive Symptoms in Breast Cancer Patient</brief_title>
  <acronym>PSYCANCER</acronym>
  <official_title>EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Beast Cancer : a Faisability Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional Metz-Thionville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Lorraine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Régional Metz-Thionville</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>
      The study will consist in an adjustment/adaptation of the &quot;standard EMDR protocol&quot; for cancer&#xD;
      disease, and most particulary for women who present a breast cancer and during adjuvant&#xD;
      therapy. It will also test the faisability of the research, with a view to adjust the&#xD;
      calendar and the ressources to put at disposal for a randomized control trial that follow.&#xD;
      This study will also allow to test the need and acceptibility of this new psychotherapy for&#xD;
      the patient, and to identify facilitators and obstacles : participation/rejection ratio,&#xD;
      inclusion rythm, adhesion of the medical staff about the project&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">July 25, 2018</completion_date>
  <primary_completion_date type="Actual">July 25, 2018</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>
    <intervention_model_description>All the women will receive the same intervention.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>patients involvement</measure>
    <time_frame>week 12</time_frame>
    <description>acceptability of the new psychotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adequacy of the intervention with the field</measure>
    <time_frame>Week 12</time_frame>
    <description>adaptability of the EMDR protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires</measure>
    <time_frame>Week 12</time_frame>
    <description>ratio of patients which wants to participate and effectively participate</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Eye Movement Desensitization and Processing</condition>
  <condition>Psychoterapy</condition>
  <arm_group>
    <arm_group_label>Arms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: EMDR psychotherapy All the women will be in this arm and thus will receive the same intervention which is : 8 sessions (1 per week). The first session is an inclusion visit at Metz-Thionville Hospital, then 6 EMDR psychotherapy sessions and finally a last visit one month after for data recovery (questionnaire and semi-directive interview)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EMDR psychotherapy</intervention_name>
    <description>Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient supporting Visit 3 : EMDR psychotherapy care Visit 4 : EMDR psychotherapy care Visit 5 : EMDR psychotherapy care and questionnaires Visit 6 : EMDR psychotherapy care Visit 7 : EMDR psychotherapy care Visit 8 : EMDR psychotherapy care ans questionnaires Visit 9 (one month after) : semi-directive interview and data recovery (questionnaires)</description>
    <arm_group_label>Arms</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being a woman aged of 18 years or more&#xD;
&#xD;
          -  Having a primary invasive breast cancer&#xD;
&#xD;
          -  Having undergo a mastectomy for a primary invasive breast cancer&#xD;
&#xD;
          -  Being able to complete the questionnaires&#xD;
&#xD;
          -  Being informed of the study and having signed the informed consent&#xD;
&#xD;
          -  Being affiliated to a welfare system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having contraindications to recieve EMDR psychotherapy (neurologic disorders,&#xD;
             dissociatif states, oculomotor issues)&#xD;
&#xD;
          -  Having started adjuvant treatments following surgery&#xD;
&#xD;
          -  Having metastatic breast cancer&#xD;
&#xD;
          -  Presenting physical polypathologies&#xD;
&#xD;
          -  Having psychiatric antecedents (included anxiety and depressif disorders - assessed&#xD;
             with M.I.N.I. (Sheehan and al., 1997)).&#xD;
&#xD;
          -  Having drug or alcohol addiction&#xD;
&#xD;
          -  Being placed under the safeguard of justice, guardianship or trusteeship&#xD;
&#xD;
          -  Being pregnant or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rafaele Longo, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHR Metz-Thionville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHR Metz-Thionville</name>
      <address>
        <city>Metz</city>
        <zip>57085</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>EMDR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03271476
org study id: 2017-01-CHRMT
nct id: NCT03271476
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will consist in an adjustment/adaptation of the "standard EMDR protocol" for cancer
      disease, and most particulary for women who present a breast cancer and during adjuvant
      therapy. It will also test the faisability of the research, with a view to adjust the
      calendar and the ressources to put at disposal for a randomized control trial that follow.
      This study will also allow to test the need and acceptibility of this new psychotherapy for
      the patient, and to identify facilitators and obstacles : participation/rejection ratio,
      inclusion rythm, adhesion of the medical staff about the project
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All the women will receive the same intervention.
primary purpose: Supportive Care
masking: None (Open Label)
measure: patients involvement
time frame: week 12
description: acceptability of the new psychotherapy
measure: adequacy of the intervention with the field
time frame: Week 12
description: adaptability of the EMDR protocol
measure: EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires
time frame: Week 12
description: ratio of patients which wants to participate and effectively participate
arm group label: Arms
arm group type: Experimental
description: Experimental: EMDR psychotherapy All the women will be in this arm and thus will receive the same intervention which is : 8 sessions (1 per week). The first session is an inclusion visit at Metz-Thionville Hospital, then 6 EMDR psychotherapy sessions and finally a last visit one month after for data recovery (questionnaire and semi-directive interview)
intervention type: Behavioral
intervention name: EMDR psychotherapy
description: Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient supporting Visit 3 : EMDR psychotherapy care Visit 4 : EMDR psychotherapy care Visit 5 : EMDR psychotherapy care and questionnaires Visit 6 : EMDR psychotherapy care Visit 7 : EMDR psychotherapy care Visit 8 : EMDR psychotherapy care ans questionnaires Visit 9 (one month after) : semi-directive interview and data recovery (questionnaires)
arm group label: Arms
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rafaele Longo, Dr
role: Principal Investigator
affiliation: CHR Metz-Thionville
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Depression
sharing ipd: Undecided