<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/NCT04454723</url>
  </required_header>
  <id_info>
    <org_study_id>OU022019JH_Palliative QOL</org_study_id>
    <nct_id>NCT04454723</nct_id>
  </id_info>
  <brief_title>Impact of Palliative Transfusions on Quality of Life in Patients With Blood Cancers on Hospice</brief_title>
  <official_title>Impact of Palliative Transfusions on Quality of Life in Patients With Hematological Malignancies on Hospice - A Case Series Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this pilot research study is to evaluate the effectiveness of blood and&#xD;
      platelet transfusions in improving symptoms and quality of life of patients enrolled in&#xD;
      hospice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-randomized pilot study to investigate the feasibility of symptom-based blood&#xD;
      transfusion in patients with hematologic malignancies enrolling in hospice care.&#xD;
&#xD;
      The study will be a case series involving OU Medical Center (OUMC). Patients will be&#xD;
      identified at the University of Oklahoma/Stephenson Cancer Center (OU-SCC) where&#xD;
      investigators performing the study will consent and monitor patients. Integris Home Hospice&#xD;
      agency will provide hospice patients with blood transfusions in those willing to participate,&#xD;
      and the Oklahoma Blood Institute (OBI) will provide the hospice patients with palliative&#xD;
      transfusions at home at no cost to the patient, including blood products, transfusion&#xD;
      testing, infusions and the nursing staff.&#xD;
&#xD;
      This will be a pilot project including 20 consented patients with hematologic malignancies&#xD;
      enrolling in hospice through Integris Home Hospice. The transfusions received will be&#xD;
      determined by the hospice team, and will not be based on objective symptom based guidelines.&#xD;
      Patients will have the option to either be enrolled on this clinical trial, where they may&#xD;
      receive home based blood or platelet transfusions, or be enrolled in any other hospice of&#xD;
      their choosing, including the other hospice that will provide home based transfusions.&#xD;
      Information will be collected regarding symptoms, Hospice QOL scores and transfusion use,&#xD;
      reactions, and time in hospice. Data will be collected until death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects with improved quality of life after receiving transfusions.</measure>
    <time_frame>6 months</time_frame>
    <description>Improved quality of life (QOL) and palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects with improved palliative efficacy after receiving transfusions.</measure>
    <time_frame>6 months</time_frame>
    <description>Palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hematologic Malignancy</condition>
  <arm_group>
    <arm_group_label>Tranfusions and blood collection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients enrolled will receive one unit each of blood and/or platelet transfusions once a week based on trigger symptoms of anemia and/or thrombocytopenia, along with blood sample collections.&#xD;
Data on patient demographics, disease, and length of hospice stay will also be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood and/or platelet transfusion</intervention_name>
    <description>The transfused patients will receive one unit each of blood and/or platelet transfusions once a week based on CTCAE symptom grade 2 or greater of anemia and/or thrombocytopenia.</description>
    <arm_group_label>Tranfusions and blood collection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Complete blood count (CBC) collection</intervention_name>
    <description>CBC will be collected from patients weekly while on this protocol.</description>
    <arm_group_label>Tranfusions and blood collection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patients &gt;= 18 years irrespective of their race, sex and/or other medical history.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients &gt;= 18 years with a primary diagnosis of acute myeloid leukemia (AML),&#xD;
             acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), chronic&#xD;
             myelomonocytic leukemia (CMML), &quot;high risk&quot; Non-Hodgkin's Lymphoma (NHL), multiple&#xD;
             myeloma (MM) and Myelodysplastic Syndrome (MDS) with a life expectancy of &lt; 6 months&#xD;
             who are transfusion dependent. Criteria for transfusion dependence is Symptom&#xD;
             Questionnaire symptom grade 2 or higher. The Symptom Questionnaire is based on CTCAE&#xD;
             (Common Terminology Criteria for Adverse Events) v5.0, with criteria modified for&#xD;
             palliative care patients.&#xD;
&#xD;
          -  Patients wanting to enroll in hospice.&#xD;
&#xD;
          -  Availability of peripheral IV access line or patient agrees to have semi-permanent IV&#xD;
             line placed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with &gt; 6-month survival.&#xD;
&#xD;
          -  Patients unwilling to go on hospice.&#xD;
&#xD;
          -  Patients with antibodies to blood or platelets that would preclude ability to give&#xD;
             blood/platelets without prolonged blood typing and or need for anti-HLA platelets.&#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_official>
    <last_name>Jennifer Holter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stephenson Cancer Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hospice</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>
  </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/NCT04454723
org study id: OU022019JH_Palliative QOL
nct id: NCT04454723
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot research study is to evaluate the effectiveness of blood and
      platelet transfusions in improving symptoms and quality of life of patients enrolled in
      hospice.
This is a non-randomized pilot study to investigate the feasibility of symptom-based blood
      transfusion in patients with hematologic malignancies enrolling in hospice care.

      The study will be a case series involving OU Medical Center (OUMC). Patients will be
      identified at the University of Oklahoma/Stephenson Cancer Center (OU-SCC) where
      investigators performing the study will consent and monitor patients. Integris Home Hospice
      agency will provide hospice patients with blood transfusions in those willing to participate,
      and the Oklahoma Blood Institute (OBI) will provide the hospice patients with palliative
      transfusions at home at no cost to the patient, including blood products, transfusion
      testing, infusions and the nursing staff.

      This will be a pilot project including 20 consented patients with hematologic malignancies
      enrolling in hospice through Integris Home Hospice. The transfusions received will be
      determined by the hospice team, and will not be based on objective symptom based guidelines.
      Patients will have the option to either be enrolled on this clinical trial, where they may
      receive home based blood or platelet transfusions, or be enrolled in any other hospice of
      their choosing, including the other hospice that will provide home based transfusions.
      Information will be collected regarding symptoms, Hospice QOL scores and transfusion use,
      reactions, and time in hospice. Data will be collected until death.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Proportion of subjects with improved quality of life after receiving transfusions.
time frame: 6 months
description: Improved quality of life (QOL) and palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.
measure: Proportion of subjects with improved palliative efficacy after receiving transfusions.
time frame: 6 months
description: Palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.
arm group label: Tranfusions and blood collection
arm group type: Experimental
description: Patients enrolled will receive one unit each of blood and/or platelet transfusions once a week based on trigger symptoms of anemia and/or thrombocytopenia, along with blood sample collections.
Data on patient demographics, disease, and length of hospice stay will also be collected.
intervention type: Procedure
intervention name: Blood and/or platelet transfusion
description: The transfused patients will receive one unit each of blood and/or platelet transfusions once a week based on CTCAE symptom grade 2 or greater of anemia and/or thrombocytopenia.
arm group label: Tranfusions and blood collection
intervention type: Procedure
intervention name: Complete blood count (CBC) collection
description: CBC will be collected from patients weekly while on this protocol.
arm group label: Tranfusions and blood collection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Holter, MD
role: Principal Investigator
affiliation: University of Oklahoma
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms
sharing ipd: No