<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/NCT02975869</url>
  </required_header>
  <id_info>
    <org_study_id>16-439</org_study_id>
    <nct_id>NCT02975869</nct_id>
  </id_info>
  <brief_title>A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia</brief_title>
  <official_title>Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is evaluating the impact a collaborative palliative care and oncology&#xD;
      team will have on the quality of life, symptoms, mood, and end of life outcomes of patients&#xD;
      with acute myeloid leukemia (AML). Palliative care is a medical specialty focused on&#xD;
      lessening (or &quot;palliating&quot;) symptoms and assisting in coping with serious illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of this study is to compare two types of care - standard leukemia oncology&#xD;
      care and standard leukemia oncology care with collaborative involvement of palliative care&#xD;
      clinicians to see which is better for improving the experience of patients and families with&#xD;
      AML undergoing treatment.&#xD;
&#xD;
      The investigators aim to find out whether introducing patients and families undergoing AML&#xD;
      treatment to the palliative care team that specializes in symptom management can improve the&#xD;
      physical and psychological symptoms that patients and families experience during their&#xD;
      hospitalizations for their leukemia care as well as enhance the quality of patients' end of&#xD;
      life care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>N/A</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>Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms</measure>
    <time_frame>2 weeks</time_frame>
    <description>We will compare patients' FACT-Leukemia scores at week-2 adjusting for baseline scores. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.</measure>
    <time_frame>up to 6 months</time_frame>
    <description>We will compare FACT-leukemia scores longitudinally between study arm. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms</measure>
    <time_frame>up to 6 months</time_frame>
    <description>We will compare patients' psychological distress using the HADS between study arms at week-2 and longitudinally between study arms. The HADS consistent of two subscales assessing anxiety and depression symptoms with scores ranging from 0-21 with higher scores indicating worse psychological distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Symptom Burden (as per ESAS) Between Study Arms.</measure>
    <time_frame>up to 6 months</time_frame>
    <description>We will compare patients' symptom burden using the Edmonton Symptom Assessment Scale (ESAS) between the two arms at week-2 and longitudinally. The ESAS ranges from 0-100 with higher scores indicating worse symptom burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms</measure>
    <time_frame>up to 6 months</time_frame>
    <description>We will compare PTSD symptoms as measured by the PTSD-Checklist (PCL) between the two groups at week-2 and longitudinally. PCL scores range from 17-85 with higher scores indicating worse PTSD symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms</measure>
    <time_frame>up to 6 months</time_frame>
    <description>We will compare patient-reported discussing their EOL care preferences between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms</measure>
    <time_frame>up to 6 months</time_frame>
    <description>to compare rates of chemotherapy administration near the end of life between the two arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms</measure>
    <time_frame>up to 6 months</time_frame>
    <description>to compare rates of hospitalizations within the last week of life between the study arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.</measure>
    <time_frame>up to 6 months</time_frame>
    <description>to compare rates of hospice utilization and length-of-stay in hospice at the end of life between the two study arms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Standard Leukemia Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Leukemia care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Collaborative Palliative and Oncology Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Collaborative care from Palliative Care and Leukemia will be given</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Leukemia Care</intervention_name>
    <arm_group_label>Standard Leukemia Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Palliative Care</intervention_name>
    <arm_group_label>Collaborative Palliative and Oncology Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patients with high-risk AML, defined as:&#xD;
&#xD;
          -  Newly diagnosed patients with AML ≥ 60 years of age&#xD;
&#xD;
          -  Newly diagnosed AML with antecedent hematologic disorder&#xD;
&#xD;
          -  Newly diagnosed therapy-related AML&#xD;
&#xD;
          -  Relapsed AML&#xD;
&#xD;
          -  Primary refractory AML&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients already receiving palliative care&#xD;
&#xD;
          -  Major psychiatric illness or comorbid conditions prohibiting compliance with study&#xD;
             procedures.&#xD;
&#xD;
          -  A diagnosis of acute promyelocytic leukemia (APML)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Areej El-Jawahri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts general Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>El-Jawahri, Areej,M.D.</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Leukemia</keyword>
  <keyword>Acute Myeloid Leukemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</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/NCT02975869
org study id: 16-439
nct id: NCT02975869
lead sponsor: 
collaborator: 
has dmc: No
This research study is evaluating the impact a collaborative palliative care and oncology
      team will have on the quality of life, symptoms, mood, and end of life outcomes of patients
      with acute myeloid leukemia (AML). Palliative care is a medical specialty focused on
      lessening (or "palliating") symptoms and assisting in coping with serious illness.
The main purpose of this study is to compare two types of care - standard leukemia oncology
      care and standard leukemia oncology care with collaborative involvement of palliative care
      clinicians to see which is better for improving the experience of patients and families with
      AML undergoing treatment.

      The investigators aim to find out whether introducing patients and families undergoing AML
      treatment to the palliative care team that specializes in symptom management can improve the
      physical and psychological symptoms that patients and families experience during their
      hospitalizations for their leukemia care as well as enhance the quality of patients' end of
      life care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms
time frame: 2 weeks
description: We will compare patients' FACT-Leukemia scores at week-2 adjusting for baseline scores. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.
measure: Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.
time frame: up to 6 months
description: We will compare FACT-leukemia scores longitudinally between study arm. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.
measure: Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms
time frame: up to 6 months
description: We will compare patients' psychological distress using the HADS between study arms at week-2 and longitudinally between study arms. The HADS consistent of two subscales assessing anxiety and depression symptoms with scores ranging from 0-21 with higher scores indicating worse psychological distress.
measure: Compare Symptom Burden (as per ESAS) Between Study Arms.
time frame: up to 6 months
description: We will compare patients' symptom burden using the Edmonton Symptom Assessment Scale (ESAS) between the two arms at week-2 and longitudinally. The ESAS ranges from 0-100 with higher scores indicating worse symptom burden.
measure: Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms
time frame: up to 6 months
description: We will compare PTSD symptoms as measured by the PTSD-Checklist (PCL) between the two groups at week-2 and longitudinally. PCL scores range from 17-85 with higher scores indicating worse PTSD symptoms
measure: Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms
time frame: up to 6 months
description: We will compare patient-reported discussing their EOL care preferences between the two groups
measure: Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms
time frame: up to 6 months
description: to compare rates of chemotherapy administration near the end of life between the two arms
measure: Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms
time frame: up to 6 months
description: to compare rates of hospitalizations within the last week of life between the study arms
measure: Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.
time frame: up to 6 months
description: to compare rates of hospice utilization and length-of-stay in hospice at the end of life between the two study arms
arm group label: Standard Leukemia Care
arm group type: Active Comparator
description: Standard Leukemia care
arm group label: Collaborative Palliative and Oncology Care
arm group type: Experimental
description: Collaborative care from Palliative Care and Leukemia will be given
intervention type: Other
intervention name: Standard Leukemia Care
arm group label: Standard Leukemia Care
intervention type: Other
intervention name: Palliative Care
arm group label: Collaborative Palliative and Oncology Care
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Areej El-Jawahri, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: El-Jawahri, Areej,M.D.
investigator title: MD
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No