<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/NCT04410185</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A00485-34</org_study_id>
    <nct_id>NCT04410185</nct_id>
  </id_info>
  <brief_title>Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology</brief_title>
  <acronym>IMPLIC</acronym>
  <official_title>Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology to Improve Stress and Quality of Life With Joint Participation of &quot;Witness / Patient / Caregivers&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Francois Baclesse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation de France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancéropôle Nord-Ouest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Francois Baclesse</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 is based on the realization of a meditation program associating patients,&#xD;
      caregivers and control subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Actual">February 11, 2021</completion_date>
  <primary_completion_date type="Actual">February 11, 2021</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>3 separate populations will be recruited: Patients (n=10), caregivers (n=10), and control subjects (n=10)</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the adherence of all participants to the full meditation program</measure>
    <time_frame>3 months after the beginning of program</time_frame>
    <description>Proportion of participants adhering to the full meditation program (13 sessions)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Cancer</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>MEDITATION</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Meditation sessions will take place over 12 weekly sessions of 1.5 hours. A retreat (3 hours) will be realized after the 9th session</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Meditation</intervention_name>
    <description>Meditation sessions will take place over 12 weekly sessions of 1.5 hours</description>
    <arm_group_label>MEDITATION</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for all participants (patients, caregivers and control subjects)&#xD;
&#xD;
          -  Participants aged 18 or over&#xD;
&#xD;
          -  Curious and motivated participant to participate in the program&#xD;
&#xD;
          -  Participant with no current or previous experience of regular or intensive practice of&#xD;
             meditation or a comparable practice. The practice is considered regular and / or&#xD;
             intensive if:&#xD;
&#xD;
               -  it occurs more than one day per week for more than 6 consecutive months over the&#xD;
                  last 10 years,&#xD;
&#xD;
               -  and / or in case of more than 5 consecutive days of intensive practice&#xD;
                  (internship or retirement) in the last 10 years,&#xD;
&#xD;
               -  and / or more than 25 consecutive days of (cumulative) retirement over the last&#xD;
                  10 years.&#xD;
&#xD;
          -  Participant available to follow the full meditation program (3 month period)&#xD;
&#xD;
          -  Participant agreeing to participate by signing the study information note&#xD;
&#xD;
          -  Participant able to understand, speak and read French&#xD;
&#xD;
          -  Patient capable of using digital media and having an internet connection&#xD;
&#xD;
        Patient-specific criteria (target population)&#xD;
&#xD;
          -  Patients with cancer,&#xD;
&#xD;
          -  State of health compatible with the study meditation program&#xD;
&#xD;
          -  Patient affiliated to a social Health sytem&#xD;
&#xD;
        Caregiver-specific criteria&#xD;
&#xD;
          -  All medical and / or paramedical staff of the sponsor Center in contact with patients&#xD;
             (doctors, nurse, caregiver, radiotherapy manipulator MERM)&#xD;
&#xD;
        Criteria specific to the control population - Any voluntary person not belonging to the two&#xD;
        categories above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For all participants&#xD;
&#xD;
          -  Participant with significant vulnerability factors dependence on alcohol and drugs,&#xD;
             severe depression, severe social anxiety, recent mourning etc.).&#xD;
&#xD;
          -  Participant who cannot submit to the follow-up of the trial for geographic, social or&#xD;
             psychopathological reasons&#xD;
&#xD;
        For patients&#xD;
&#xD;
          -  Very advanced stage of cancer disease with life-threatening commitment,&#xD;
&#xD;
          -  Participant deprived of liberty or under guardianship&#xD;
&#xD;
        For control subjects&#xD;
&#xD;
        - Nursing staff, regardless of their place of practice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>meditation</keyword>
  <keyword>caregivers</keyword>
  <keyword>patients with cancer</keyword>
  <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/NCT04410185
org study id: 2020-A00485-34
nct id: NCT04410185
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is based on the realization of a meditation program associating patients,
      caregivers and control subjects
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 3 separate populations will be recruited: Patients (n=10), caregivers (n=10), and control subjects (n=10)
primary purpose: Other
masking: None (Open Label)
measure: Evaluate the adherence of all participants to the full meditation program
time frame: 3 months after the beginning of program
description: Proportion of participants adhering to the full meditation program (13 sessions)
arm group label: MEDITATION
arm group type: Experimental
description: Meditation sessions will take place over 12 weekly sessions of 1.5 hours. A retreat (3 hours) will be realized after the 9th session
intervention type: Behavioral
intervention name: Meditation
description: Meditation sessions will take place over 12 weekly sessions of 1.5 hours
arm group label: MEDITATION
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No