<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/NCT03800095</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-406</org_study_id>
    <secondary_id>2017-A02515-48</secondary_id>
    <nct_id>NCT03800095</nct_id>
  </id_info>
  <brief_title>Early Palliative Care for Patients With Haematological Malignancies</brief_title>
  <acronym>CALVI</acronym>
  <official_title>Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation Apicil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Association des foulées de la Haute Lozère</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Association CEMSBM</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Connaître et Combattre les Myélodysplasies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients suffering from haematological disease present symptoms of discomfort and currently&#xD;
      benefit from palliative care skills only for the management of their end-of-life. However, in&#xD;
      medical oncology, more and more studies tend to demonstrate the benefit on the quality of&#xD;
      life of an early collaboration between the two specialties.&#xD;
&#xD;
      Investigator did the hypothesis that early integration of palliative care with conventional&#xD;
      haematological care could decrease discomfort symptoms and add a real benefit on the&#xD;
      patients' quality of life .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients suffering from haematological disease present symptoms of discomfort and currently&#xD;
      benefit from palliative care skills only for the management of their end-of-life. However, in&#xD;
      medical oncology, more and more studies tend to demonstrate the benefit on the quality of&#xD;
      life of an early collaboration between the two specialties.&#xD;
&#xD;
      Investigator did the hypothesis that early integration of palliative care with conventional&#xD;
      haematological care could decrease discomfort symptoms and add a real benefit on the&#xD;
      patients' quality of life .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 14, 2023</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life evaluation: standardized questionnaire</measure>
    <time_frame>at 6 months</time_frame>
    <description>Evaluation of quality of life by a standardized questionnaire : Functional Assessment of Cancer Therapy-Anemia (FACT-An). The higher is the score the better is the quality of life. FACT-An is composed by five subscales: Physical Well-Being [score range 0-28], Social/Family Well-Being [score range 0-28], Emotional Well-Being [score range 0-24], and Functional Well-Being [score range 0-28] and specific questions concerning anemia [score range 0-80]. The score at each items is summed. The sum is multiplied par the number of items in the subscale and then divided by the number of items answered. This produces the subscale score. The subscale scores are added to derive total score [score range 0-188].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of discomfort symptoms</measure>
    <time_frame>at Day 0, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>at day 1 : from the randomization until the date of death or until 1 year [study end].</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of the care pathwaydesired by the patient</measure>
    <time_frame>at 12 months or death</time_frame>
    <description>matching between patients desires writing in the medical file and the providing care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost-effectiveness analysis</measure>
    <time_frame>at 12 months or death</time_frame>
    <description>The cost criteria selected will be all the direct medical costs inherent in care in both arms (costs of hospitalizations, consultations, treatments, medical devices).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Myelodysplastic Syndrome</condition>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>Conventional haematological care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with haematological malignancy Conventional haematological care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional care associated with a monthly consultation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Early palliative care integration</intervention_name>
    <description>The follow-up time for each patient is 12 months with evaluation of the main objective by a standardized questionnaire: The Functional Assessment of Cancer Therapy-Anaemia (FACT-An) Scale at 6 months. Throughout the study, patients included will receive conventional haematological care and the interventional arm will benefit in addition to a monthly consultation by a palliative care team.</description>
    <arm_group_label>Conventional care associated with a monthly consultation</arm_group_label>
    <arm_group_label>Conventional haematological care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are over 70 years old&#xD;
&#xD;
          -  Patients from being diagnosed with acute myeloid leukemia and high-risk&#xD;
             myelodysplastic syndrome or after the third line of therapy for high-grade lymphoma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients with a curative project (induction chemotherapy ou allogenic&#xD;
             transplantation)&#xD;
&#xD;
          -  All patients in a terminal palliative status&#xD;
&#xD;
          -  Patients who don't speak French,&#xD;
&#xD;
          -  Patients not able to read and write&#xD;
&#xD;
          -  Patients who don't agree to participate in the protocol&#xD;
&#xD;
          -  Patients with psychiatric troubles or cognitive disorders&#xD;
&#xD;
          -  Patients under guardianship or curatorship, deprived of freedom or under justice&#xD;
             protection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lise LACLAUTRE</last_name>
    <phone>0473754963</phone>
    <email>drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier Métropole Savoie</name>
      <address>
        <city>Chambéry</city>
        <zip>73000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Laurent SUTTON</last_name>
    </contact>
    <investigator>
      <last_name>Laurent SUTTON</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthieu CRETINON</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lise LACLAUTRE</last_name>
      <phone>0473754963</phone>
      <email>drci@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Virginie GUASTELLA</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jacques-Olivier BAY</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane MOREAU</last_name>
    </contact>
    <investigator>
      <last_name>Stéphane MOREAU</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bertrand SARDIN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne-Sophie MICHALLET</last_name>
    </contact>
    <investigator>
      <last_name>Anne-Sophie MICHALLET</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gisèle CHVETZOF</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de la Loire</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42271</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denis GUYOTAT</last_name>
    </contact>
    <investigator>
      <last_name>Denis GUYOTAT</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stéphanie MORISSON</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Jacques Lacarin</name>
      <address>
        <city>Vichy</city>
        <zip>03200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Karine SOULIER-GUERIN</last_name>
    </contact>
    <investigator>
      <last_name>Karine SOULIER-GUERIN</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Franck DELPRETTI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Supportive care</keyword>
  <keyword>Early palliative care</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Symptoms management</keyword>
  <keyword>Haematological malignancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Hematologic Neoplasms</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
  </condition_browse>
  <!-- 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/NCT03800095
org study id: CHU-406
secondary id: 2017-A02515-48
nct id: NCT03800095
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Patients suffering from haematological disease present symptoms of discomfort and currently
      benefit from palliative care skills only for the management of their end-of-life. However, in
      medical oncology, more and more studies tend to demonstrate the benefit on the quality of
      life of an early collaboration between the two specialties.

      Investigator did the hypothesis that early integration of palliative care with conventional
      haematological care could decrease discomfort symptoms and add a real benefit on the
      patients' quality of life .
Patients suffering from haematological disease present symptoms of discomfort and currently
      benefit from palliative care skills only for the management of their end-of-life. However, in
      medical oncology, more and more studies tend to demonstrate the benefit on the quality of
      life of an early collaboration between the two specialties.

      Investigator did the hypothesis that early integration of palliative care with conventional
      haematological care could decrease discomfort symptoms and add a real benefit on the
      patients' quality of life .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: no masking
measure: Quality of life evaluation: standardized questionnaire
time frame: at 6 months
description: Evaluation of quality of life by a standardized questionnaire : Functional Assessment of Cancer Therapy-Anemia (FACT-An). The higher is the score the better is the quality of life. FACT-An is composed by five subscales: Physical Well-Being [score range 0-28], Social/Family Well-Being [score range 0-28], Emotional Well-Being [score range 0-24], and Functional Well-Being [score range 0-28] and specific questions concerning anemia [score range 0-80]. The score at each items is summed. The sum is multiplied par the number of items in the subscale and then divided by the number of items answered. This produces the subscale score. The subscale scores are added to derive total score [score range 0-188].
measure: Presence of discomfort symptoms
time frame: at Day 0, 3 months, 6 months, 9 months, 12 months
description: evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS)
measure: overall survival
time frame: at day 1 : from the randomization until the date of death or until 1 year [study end].
measure: Satisfaction of the care pathwaydesired by the patient
time frame: at 12 months or death
description: matching between patients desires writing in the medical file and the providing care
measure: cost-effectiveness analysis
time frame: at 12 months or death
description: The cost criteria selected will be all the direct medical costs inherent in care in both arms (costs of hospitalizations, consultations, treatments, medical devices).
arm group label: Conventional haematological care
arm group type: Experimental
description: Patients with haematological malignancy Conventional haematological care
arm group label: Conventional care associated with a monthly consultation
arm group type: Experimental
description: Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team
intervention type: Drug
intervention name: Early palliative care integration
description: The follow-up time for each patient is 12 months with evaluation of the main objective by a standardized questionnaire: The Functional Assessment of Cancer Therapy-Anaemia (FACT-An) Scale at 6 months. Throughout the study, patients included will receive conventional haematological care and the interventional arm will benefit in addition to a monthly consultation by a palliative care team.
arm group label: Conventional care associated with a monthly consultation
arm group label: Conventional haematological care
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Lise LACLAUTRE
phone: 0473754963
email: drci@chu-clermontferrand.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Hematologic Neoplasms
mesh term: Myelodysplastic Syndromes