<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/NCT04412135</url>
  </required_header>
  <id_info>
    <org_study_id>87RI19_0050</org_study_id>
    <nct_id>NCT04412135</nct_id>
  </id_info>
  <brief_title>The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality</brief_title>
  <acronym>SPIRIHEMATO</acronym>
  <official_title>The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality During the Initial Healing Phase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Limoges</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 management of patients with malignant hemopathy is based on comprehensive management. In&#xD;
      this context and faced with the various difficulties encountered by cancer patients, the&#xD;
      question of spirituality and its experience is central. Spirituality refers to the person's&#xD;
      attachment to what inspires and gives him foundation, as well as the beliefs, values, and&#xD;
      existential experiences associated with it, whether these are religious in nature or not.&#xD;
      Although the concept has been identified as a resource in the literature and widely treated&#xD;
      in an end-of-life context, assessing the needs of patients with hematological cancer and&#xD;
      their loved ones in terms of spirituality from the initiation of treatment does not has not&#xD;
      been developed&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>FACIT-Sp questionnaire</measure>
    <time_frame>15 minutes</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Hematologic Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>spirituality</intervention_name>
    <description>Patients will take three questionnaires (FACIT-Sp, Euroqol 5 dimensions and ESAS)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        hematologic cancer patient and family member&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥ 18 years with a recent diagnosis of hematological cancer (lymphoma or leukemia)&#xD;
             and in treatment;&#xD;
&#xD;
          -  Patients who speak and read French;&#xD;
&#xD;
          -  Patients in general condition (physical and mental) judged emotionally and physically&#xD;
             fit by the referring nurse to answer the questionnaires;&#xD;
&#xD;
          -  Patients benefiting from a social security scheme,&#xD;
&#xD;
          -  Patients who signed the non-objection form after being informed of the study,&#xD;
&#xD;
        family person:&#xD;
&#xD;
          -  Have been designated by the patient as being the loved one they wish to include with&#xD;
             them;&#xD;
&#xD;
          -  Aged ≥ 18 years;&#xD;
&#xD;
          -  Fluent in and reading French;&#xD;
&#xD;
          -  Having signed the non-objection form after being informed of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in recurrence / progress or in remission of cancer;&#xD;
&#xD;
          -  Patients in the terminal phase of the disease.&#xD;
&#xD;
        Family person:&#xD;
&#xD;
        person in the curative phase of cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jean TONIOLO</last_name>
    <phone>+33 5 55 05 67 55</phone>
    <email>jean.toniolo@chu-limoges.fr</email>
  </overall_contact>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT04412135
org study id: 87RI19_0050
nct id: NCT04412135
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The management of patients with malignant hemopathy is based on comprehensive management. In
      this context and faced with the various difficulties encountered by cancer patients, the
      question of spirituality and its experience is central. Spirituality refers to the person's
      attachment to what inspires and gives him foundation, as well as the beliefs, values, and
      existential experiences associated with it, whether these are religious in nature or not.
      Although the concept has been identified as a resource in the literature and widely treated
      in an end-of-life context, assessing the needs of patients with hematological cancer and
      their loved ones in terms of spirituality from the initiation of treatment does not has not
      been developed
observational model: Cohort
time perspective: Prospective
measure: FACIT-Sp questionnaire
time frame: 15 minutes
intervention type: Other
intervention name: spirituality
description: Patients will take three questionnaires (FACIT-Sp, Euroqol 5 dimensions and ESAS)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean TONIOLO
phone: +33 5 55 05 67 55
email: jean.toniolo@chu-limoges.fr
responsible party type: Sponsor
mesh term: Hematologic Neoplasms
sharing ipd: No