<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/NCT03806712</url>
  </required_header>
  <id_info>
    <org_study_id>P/2019/413</org_study_id>
    <nct_id>NCT03806712</nct_id>
  </id_info>
  <brief_title>Comprehensive Study of Social Representation of Platelet Transfusion in Patients Followed for Advanced Hematological Malignancies (R-PLQ)</brief_title>
  <acronym>R-PLQ</acronym>
  <official_title>Comprehensive Study of Social Representation of Platelet Transfusion in Patients Followed for Advanced Hematological Malignancies (R-PLQ)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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>
      Limited data is available for end of life care in hematologic malignancies, moreover with&#xD;
      thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow&#xD;
      involvement in those diseases or its treatments. Yet, a few studies was interested in,&#xD;
      whereas platelet transfusion is the only treatment indicated. As it represent a scarce,&#xD;
      limited resource, the ethical principles are in conflict in this setting and there's a lack&#xD;
      of recommendation. The final decision is take by the clinician and his patient, but no study&#xD;
      exist in representation of the two parts. We provide a qualitative study to understand what&#xD;
      this decision is made of.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">July 22, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>measure the impact of social representation on platelet transfusion practice</measure>
    <time_frame>3 months</time_frame>
    <description>inner core and peripheral items of platelet transfusion of each participant will be collected until reaching saturation, it's to say that the repetition of some terms will be measured between each interview thank's to a questionnaire of at least two principals opened questions.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Platelet Transfusion</condition>
  <condition>Hematological Malignancy</condition>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>patient</arm_group_label>
    <description>patient with advanced, non curative hematological malignancies multi method questionary, at least 1 hour per patient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hematologist</arm_group_label>
    <description>medical practitioner of platelet transfusion multi method questionary, at least 1 hour per hematologist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nurses</arm_group_label>
    <description>nurses working in hematology, practicing platelet transfusion multi method questionary, at least 1 hour per nurse</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>multi method questionary (developped by De Rosa, in 1995 and 2014)</intervention_name>
    <description>questions from an association network according to the subject and the grounded theorise (Glasser and Strauss)</description>
    <arm_group_label>Nurses</arm_group_label>
    <arm_group_label>hematologist</arm_group_label>
    <arm_group_label>patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with advanced hematological malignancies, transfused in platelet regulary,&#xD;
        hematologist's nurses who practice platelet transfusion and hematologist who prescribe the&#xD;
        transfusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  major patient&#xD;
&#xD;
          -  patient with advanced hematological malignancies&#xD;
&#xD;
          -  patient transfused in platelet regularly (3 time at least in last month)&#xD;
&#xD;
          -  medical practioner, hematologist, prescribing platelet transfusion at least one per&#xD;
             week.&#xD;
&#xD;
          -  nurse working in hematology, practicing platelet transfusion at lest one peer week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  minor patient&#xD;
&#xD;
          -  non communicant patient&#xD;
&#xD;
          -  non transfused platelet patient&#xD;
&#xD;
          -  non voluntary patient or hematologist or nurses&#xD;
&#xD;
          -  non graduated hematologist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Moracchini</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.psychologie-sociale.com/index.php/fr/theories/normes/18-des-attributions-causales-aux-imputations-de-responsabilite</url>
    <description>social representation course</description>
  </link>
  <reference>
    <citation>McGrath P, Leahy M. Catastrophic bleeds during end-of-life care in haematology: controversies from Australian research. Support Care Cancer. 2009 May;17(5):527-37. doi: 10.1007/s00520-008-0506-1. Epub 2008 Sep 23.</citation>
    <PMID>18810505</PMID>
  </reference>
  <reference>
    <citation>McGrath P, Holewa H. Special considerations for haematology patients in relation to end-of-life care: Australian findings. Eur J Cancer Care (Engl). 2007 Mar;16(2):164-71. doi: 10.1111/j.1365-2354.2006.00745.x.</citation>
    <PMID>17371426</PMID>
  </reference>
  <reference>
    <citation>Jeoffrion C, Dupont P, Tripodi D, Roland-Levy C. [Social representations of illness: Comparison of &quot;expert&quot; knowledge and &quot;naive&quot; knowledge]. Encephale. 2016 Jun;42(3):226-33. doi: 10.1016/j.encep.2015.12.007. Epub 2016 Jan 12. French.</citation>
    <PMID>26796561</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>social representation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>interview will be registered then transcribe on professional computer ans accessible only by the investigator and collaborators.</ipd_description>
  </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/NCT03806712
org study id: P/2019/413
nct id: NCT03806712
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Limited data is available for end of life care in hematologic malignancies, moreover with
      thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow
      involvement in those diseases or its treatments. Yet, a few studies was interested in,
      whereas platelet transfusion is the only treatment indicated. As it represent a scarce,
      limited resource, the ethical principles are in conflict in this setting and there's a lack
      of recommendation. The final decision is take by the clinician and his patient, but no study
      exist in representation of the two parts. We provide a qualitative study to understand what
      this decision is made of.
observational model: Other
time perspective: Prospective
measure: measure the impact of social representation on platelet transfusion practice
time frame: 3 months
description: inner core and peripheral items of platelet transfusion of each participant will be collected until reaching saturation, it's to say that the repetition of some terms will be measured between each interview thank's to a questionnaire of at least two principals opened questions.
arm group label: patient
description: patient with advanced, non curative hematological malignancies multi method questionary, at least 1 hour per patient
arm group label: hematologist
description: medical practitioner of platelet transfusion multi method questionary, at least 1 hour per hematologist
arm group label: Nurses
description: nurses working in hematology, practicing platelet transfusion multi method questionary, at least 1 hour per nurse
intervention type: Other
intervention name: multi method questionary (developped by De Rosa, in 1995 and 2014)
description: questions from an association network according to the subject and the grounded theorise (Glasser and Strauss)
arm group label: Nurses
arm group label: hematologist
arm group label: patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: France
url: http://www.psychologie-sociale.com/index.php/fr/theories/normes/18-des-attributions-causales-aux-imputations-de-responsabilite
description: social representation course
citation: McGrath P, Leahy M. Catastrophic bleeds during end-of-life care in haematology: controversies from Australian research. Support Care Cancer. 2009 May;17(5):527-37. doi: 10.1007/s00520-008-0506-1. Epub 2008 Sep 23.
PMID: 18810505
citation: McGrath P, Holewa H. Special considerations for haematology patients in relation to end-of-life care: Australian findings. Eur J Cancer Care (Engl). 2007 Mar;16(2):164-71. doi: 10.1111/j.1365-2354.2006.00745.x.
PMID: 17371426
citation: Jeoffrion C, Dupont P, Tripodi D, Roland-Levy C. [Social representations of illness: Comparison of "expert" knowledge and "naive" knowledge]. Encephale. 2016 Jun;42(3):226-33. doi: 10.1016/j.encep.2015.12.007. Epub 2016 Jan 12. French.
PMID: 26796561
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms
sharing ipd: No
ipd description: interview will be registered then transcribe on professional computer ans accessible only by the investigator and collaborators.