xml: <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/NCT06041607</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A01373-42</org_study_id>
      <nct_id>NCT06041607</nct_id>
    </id_info>
    <brief_title>SHARED MEDITATION INVOLVING PEOPLE WITH CANCER, CARERS AND THIRD PARTIES</brief_title>
    <acronym>IMPLIC2</acronym>
    <official_title>SHARED MEDITATION INVOLVING PEOPLE WITH CANCER, CARERS AND THIRD PARTIES: ANY ADDED VALUE COMPARED WITH MEDITATION CONDUCTED WITH PATIENTS? IMPLIC 2, A RANDOMISED STUDY</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Francois Baclesse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        Although the benefits of meditation are increasingly well documented, few hospitals offer&#xD;
        this integrative approach in their supportive cancer care. Meditation is sometimes provided,&#xD;
        but its potential benefits remain insufficiently evaluated.&#xD;
  &#xD;
        Our project is based on the hypothesis that there could be a benefit in meditating together.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main aims of our randomised study are to improve well-being, strengthen links between&#xD;
        carers, patients and third parties and raise awareness of the importance of living together&#xD;
        better by offering meditation as a shared activity. The expected benefits of meditation&#xD;
        therefore primarily concern the relief of psychological suffering. Promoting better&#xD;
        understanding between carers and patients, and looking at oneself and others in a different&#xD;
        way are experiences that aim to encourage exchanges and interactions between populations. For&#xD;
        cancer patients (the target population), pain and other symptoms associated with the disease&#xD;
        and its treatment will be better managed.&#xD;
  &#xD;
        The pain experienced by carers, which is essentially linked to professional overwork and&#xD;
        contact with illness, will be considered and managed through meditation, resulting in&#xD;
        benefits for carers and their way of interacting with their patients.&#xD;
  &#xD;
        The expected collective benefit is to develop and better live together our interdependence&#xD;
        and humanity, by recognising suffering as a shared characteristic, despite our specific&#xD;
        problems (as patients, carers or third parties).&#xD;
  &#xD;
        The overall aim is to alleviate suffering, which is an integral part of the human experience,&#xD;
        by cultivating our common humanity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To assess the possible added value for patients (target population) of a meditation programme shared between patients, carers and third parties, compared with the same meditation programme conducted solely for patients.</measure>
      <time_frame>measured at the end of the meditation programme (after the 12 weekly sessions) compared with the measurement at inclusion</time_frame>
      <description>Changes in self-efficacy scores according to the Generalized Self Efficacy Scale (GSES</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Patients With Cancer</condition>
    <arm_group>
      <arm_group_label>Shared meditation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Shared&quot; meditation: mixed groups of patients, carers and third parties</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Meditation &quot;patients&quot;</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>groups of patients only</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Shared meditation</intervention_name>
      <description>Meditation sessions between patients, carers and third parties&#xD;
  12 weekly 2-hour sessions,&#xD;
  2 half-day 3-hour retreats after the 9th session and at the end of the programme&#xD;
  3 monthly follow-up sessions (2h) in remote format (videoconference)</description>
      <arm_group_label>Shared meditation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Meditation with patients oly</intervention_name>
      <description>Meditation sessions between patients only&#xD;
  12 weekly 2-hour sessions,&#xD;
  2 half-day 3-hour retreats after the 9th session and at the end of the programme&#xD;
  3 monthly follow-up sessions (2h) in remote format (videoconference)</description>
      <arm_group_label>Meditation &quot;patients&quot;</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Criteria for all participants (patients, carers and third parties)&#xD;
  &#xD;
            -  Participant with no current or previous experience of regular or intensive meditation&#xD;
               or comparable practice. Practice is considered regular and/or intensive if :&#xD;
  &#xD;
            -  it occurs more than one day a week for more than 6 consecutive months over the last 10&#xD;
               years,&#xD;
  &#xD;
            -  and/or more than 5 consecutive days of intensive practice (course or retreat) in the&#xD;
               last 10 years,&#xD;
  &#xD;
            -  and/or more than 25 consecutive days of retreat (cumulative) in the last 10 years.&#xD;
  &#xD;
          Patient-specific criteria (target population) - Cancer patients (regardless of location)&#xD;
  &#xD;
          Specific criteria for carers&#xD;
  &#xD;
          - All medical and/or paramedical care staff at the Centre François Baclesse in contact with&#xD;
          patients (doctors, nurses, nursing assistants, radiotherapy technicians, etc.)&#xD;
  &#xD;
          Specific criteria for third parties- Any volunteer not belonging to the two categories&#xD;
          above&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with significant vulnerability factors such as alcohol or drug&#xD;
               dependence, severe depression, severe social anxiety, recent bereavement, etc.)&#xD;
  &#xD;
            -  Participant unable to undergo trial monitoring for geographical, social or&#xD;
               psychopathological reasons&#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>
      <status>Recruiting</status>
      <contact>
        <last_name>Virginie PREVOST, Pharmacien</last_name>
        <phone>33231455050</phone>
        <email>virginie.prevost@unicaen.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>meditation</keyword>
    <keyword>carer</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041607
  org study id: 2023-A01373-42
  nct id: NCT06041607
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Although the benefits of meditation are increasingly well documented, few hospitals offer
        this integrative approach in their supportive cancer care. Meditation is sometimes provided,
        but its potential benefits remain insufficiently evaluated.
  
        Our project is based on the hypothesis that there could be a benefit in meditating together.
  The main aims of our randomised study are to improve well-being, strengthen links between
        carers, patients and third parties and raise awareness of the importance of living together
        better by offering meditation as a shared activity. The expected benefits of meditation
        therefore primarily concern the relief of psychological suffering. Promoting better
        understanding between carers and patients, and looking at oneself and others in a different
        way are experiences that aim to encourage exchanges and interactions between populations. For
        cancer patients (the target population), pain and other symptoms associated with the disease
        and its treatment will be better managed.
  
        The pain experienced by carers, which is essentially linked to professional overwork and
        contact with illness, will be considered and managed through meditation, resulting in
        benefits for carers and their way of interacting with their patients.
  
        The expected collective benefit is to develop and better live together our interdependence
        and humanity, by recognising suffering as a shared characteristic, despite our specific
        problems (as patients, carers or third parties).
  
        The overall aim is to alleviate suffering, which is an integral part of the human experience,
        by cultivating our common humanity.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: To assess the possible added value for patients (target population) of a meditation programme shared between patients, carers and third parties, compared with the same meditation programme conducted solely for patients.
  time frame: measured at the end of the meditation programme (after the 12 weekly sessions) compared with the measurement at inclusion
  description: Changes in self-efficacy scores according to the Generalized Self Efficacy Scale (GSES
  arm group label: Shared meditation
  arm group type: Experimental
  description: Shared" meditation: mixed groups of patients, carers and third parties
  arm group label: Meditation "patients"
  arm group type: Active Comparator
  description: groups of patients only
  intervention type: Behavioral
  intervention name: Shared meditation
  description: Meditation sessions between patients, carers and third parties
  12 weekly 2-hour sessions,
  2 half-day 3-hour retreats after the 9th session and at the end of the programme
  3 monthly follow-up sessions (2h) in remote format (videoconference)
  arm group label: Shared meditation
  intervention type: Behavioral
  intervention name: Meditation with patients oly
  description: Meditation sessions between patients only
  12 weekly 2-hour sessions,
  2 half-day 3-hour retreats after the 9th session and at the end of the programme
  3 monthly follow-up sessions (2h) in remote format (videoconference)
  arm group label: Meditation "patients"
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  sharing ipd: No