<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/NCT04482894</url>
  </required_header>
  <id_info>
    <org_study_id>HSR 200133</org_study_id>
    <nct_id>NCT04482894</nct_id>
  </id_info>
  <brief_title>Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or MDS</brief_title>
  <official_title>Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or High-Risk Myelodysplastic Syndrome: Randomized Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</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 study is to estimate the potential benefit of early and continued&#xD;
      palliative care (PC) consultation on end of life issues.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants in this study will be randomized to either an intervention group or a standard&#xD;
      of care group. Participants in the intervention group will participate in regular visits with&#xD;
      a palliative (or supportive) care specialist, while participants in the standard of care&#xD;
      group will only see palliative care specialists if the clinician requests a referral. All&#xD;
      participants will be asked to complete monthly questionnaires regarding their general&#xD;
      well-being.&#xD;
&#xD;
      Participants have a greater chance of being assigned to the intervention group than to the&#xD;
      standard of care group. On average, in every 5 people randomized, 3 will be randomized to the&#xD;
      intervention and 2 will be randomized to standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
  <phase>Phase 2</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>Place of death</measure>
    <time_frame>At the time of death (for participants that die), assessed from enrollment through study completion, an average of 2 years</time_frame>
    <description>Location of death (ICU, inpatient floor, hospice, home)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From enrollment through participant death or end of study from enrollment through participant death or study completion, an average of 2 years.</time_frame>
    <description>Time from enrollment through death (for participants that die)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalizations</measure>
    <time_frame>From enrollment through participant death or study completion, an average of 2 years.</time_frame>
    <description>Duration of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type(s) of hospitalizations</measure>
    <time_frame>From enrollment through participant death or study completion, an average of 2 years.</time_frame>
    <description>Type(s) of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of hospitalizations</measure>
    <time_frame>From enrollment through participant death or study completion, an average of 2 years.</time_frame>
    <description>Frequency of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency department visits</measure>
    <time_frame>From enrollment through participant death or study completion, an average of 2 years.</time_frame>
    <description>Frequency/Number of emergency department visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospice services use</measure>
    <time_frame>From enrollment through participant death or study completion, an average of 2 years.</time_frame>
    <description>Dates of use of hospice services</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusions</measure>
    <time_frame>From enrollment through participant death or study completion, an average of 2 years.</time_frame>
    <description>Frequency/number and types of transfusions received</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measure</measure>
    <time_frame>At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years.</time_frame>
    <description>Quality of life based on FACT-Leukemia questionnaire, scored from 0 to 176, with a higher score indicating better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Code status change</measure>
    <time_frame>From enrollment through participant death or study completion, an average of 2 years.</time_frame>
    <description>Dates and types of changes to code status (e.g. Do not rescuscitate (DNR) with details)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goals of Care (GOC) Discussions</measure>
    <time_frame>From enrollment through participant death or study completion, an average of 2 years.</time_frame>
    <description>Whether a GOC discussion occurs while on study, and if so, date and location of discussion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Leukemia, Acute</condition>
  <condition>AML, Adult</condition>
  <condition>ALL, Adult</condition>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>Palliative Care Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants on this arm will see a palliative care specialist twice a week while they are in the hospital and about every other week when they are out of the hospital. If participants see their oncologist less often than every other week while they're out of the hospital, then visits with the palliative care specialist would be timed to occur on the same day as the oncologist visit. Participants will complete a questionnaire about once a month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Clinical Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will see a palliative care specialist only if they have a referral from their oncologist according to standard clinical care. Participants on this arm will not be discouraged from requesting a consult.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Palliative Care Visits</intervention_name>
    <description>Regular visits with a palliative (supportive) care specialist</description>
    <arm_group_label>Palliative Care Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to provide informed consent&#xD;
&#xD;
          2. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          3. Any of the following:&#xD;
&#xD;
               1. Patients with a new diagnosis of AML, ALL, high risk myelodysplastic syndrome&#xD;
                  (MDS), or high risk chronic myelomonocytic leukemia (CMML) who are age 65 and&#xD;
                  older.&#xD;
&#xD;
                  OR&#xD;
&#xD;
               2. Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 and&#xD;
                  older.&#xD;
&#xD;
                  OR&#xD;
&#xD;
               3. Patients with refractory AML, ALL, high risk MDS or high risk CMML, ages 18 and&#xD;
                  older.&#xD;
&#xD;
        Refractory AML/ALL will be defined as persistent leukemia despite two or more cycles of&#xD;
        induction chemotherapy.&#xD;
&#xD;
        Refractory MDS will be defined according to the 2006 IWG response criteria Refractory CMML&#xD;
        will be based on the assessment of the treating investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Participants must not have a diagnosis of Acute Promyelocytic Leukemia (APL)&#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>Firas El Chaer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Emily Leytham</last_name>
    <phone>(434) 924-7621</phone>
    <email>EL5MF@hscmail.mcc.virginia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Morgan van Ornum</last_name>
    <phone>(434) 297-4579</phone>
    <email>NQK9GS@hscmail.mcc.virginia.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Leytham</last_name>
      <phone>434-924-7621</phone>
      <email>EL5MF@hscmail.mcc.virginia.edu</email>
    </contact>
    <contact_backup>
      <last_name>Emily Hoade</last_name>
      <phone>(434) 243-3983</phone>
      <email>ESH5RQ@hscmail.mcc.virginia.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Firas El Chaer, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</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/NCT04482894
org study id: HSR 200133
nct id: NCT04482894
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to estimate the potential benefit of early and continued
      palliative care (PC) consultation on end of life issues.
Participants in this study will be randomized to either an intervention group or a standard
      of care group. Participants in the intervention group will participate in regular visits with
      a palliative (or supportive) care specialist, while participants in the standard of care
      group will only see palliative care specialists if the clinician requests a referral. All
      participants will be asked to complete monthly questionnaires regarding their general
      well-being.

      Participants have a greater chance of being assigned to the intervention group than to the
      standard of care group. On average, in every 5 people randomized, 3 will be randomized to the
      intervention and 2 will be randomized to standard of care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Place of death
time frame: At the time of death (for participants that die), assessed from enrollment through study completion, an average of 2 years
description: Location of death (ICU, inpatient floor, hospice, home)
measure: Overall survival
time frame: From enrollment through participant death or end of study from enrollment through participant death or study completion, an average of 2 years.
description: Time from enrollment through death (for participants that die)
measure: Duration of hospitalizations
time frame: From enrollment through participant death or study completion, an average of 2 years.
description: Duration of hospitalizations
measure: Type(s) of hospitalizations
time frame: From enrollment through participant death or study completion, an average of 2 years.
description: Type(s) of hospitalizations
measure: Frequency of hospitalizations
time frame: From enrollment through participant death or study completion, an average of 2 years.
description: Frequency of hospitalizations
measure: Emergency department visits
time frame: From enrollment through participant death or study completion, an average of 2 years.
description: Frequency/Number of emergency department visits
measure: Hospice services use
time frame: From enrollment through participant death or study completion, an average of 2 years.
description: Dates of use of hospice services
measure: Transfusions
time frame: From enrollment through participant death or study completion, an average of 2 years.
description: Frequency/number and types of transfusions received
measure: Quality of life measure
time frame: At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years.
description: Quality of life based on FACT-Leukemia questionnaire, scored from 0 to 176, with a higher score indicating better quality of life
measure: Code status change
time frame: From enrollment through participant death or study completion, an average of 2 years.
description: Dates and types of changes to code status (e.g. Do not rescuscitate (DNR) with details)
measure: Goals of Care (GOC) Discussions
time frame: From enrollment through participant death or study completion, an average of 2 years.
description: Whether a GOC discussion occurs while on study, and if so, date and location of discussion
arm group label: Palliative Care Intervention
arm group type: Experimental
description: Participants on this arm will see a palliative care specialist twice a week while they are in the hospital and about every other week when they are out of the hospital. If participants see their oncologist less often than every other week while they're out of the hospital, then visits with the palliative care specialist would be timed to occur on the same day as the oncologist visit. Participants will complete a questionnaire about once a month.
arm group label: Standard Clinical Care
arm group type: No Intervention
description: Participants will see a palliative care specialist only if they have a referral from their oncologist according to standard clinical care. Participants on this arm will not be discouraged from requesting a consult.
intervention type: Other
intervention name: Palliative Care Visits
description: Regular visits with a palliative (supportive) care specialist
arm group label: Palliative Care Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Firas El Chaer, MD
role: Principal Investigator
affiliation: University of Virginia
last name: Emily Leytham
phone: (434) 924-7621
email: EL5MF@hscmail.mcc.virginia.edu
last name: Morgan van Ornum
phone: (434) 297-4579
email: NQK9GS@hscmail.mcc.virginia.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Firas El Chaer, MD
investigator title: Assistant Professor
mesh term: Leukemia
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome
sharing ipd: No