<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/NCT02207322</url>
  </required_header>
  <id_info>
    <org_study_id>14-241</org_study_id>
    <nct_id>NCT02207322</nct_id>
  </id_info>
  <brief_title>Supportive Care Intervention In Patients Hospitalized For Hematopoietic Stem Cell Transplantation (Shield)</brief_title>
  <acronym>SHIELD</acronym>
  <official_title>Randomized Study of a Targeted Inpatient Supportive Care Intervention in Patients Hospitalized for Hematopoietic Stem Cell Transplantation (HSCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to assess whether early integration of palliative and&#xD;
      supportive care services in care of patients hospitalized for hematopoietic stem cell&#xD;
      transplantation (HSCT) can improve patients' and family caregivers' quality of life and mood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study is evaluating the impact of early involvement of supportive care team&#xD;
      working with the transplant oncology team will have on the quality of life, symptoms, and&#xD;
      mood of patients undergoing stem cell transplantation.&#xD;
&#xD;
      The purpose of this research study is to find out whether introducing patients and families&#xD;
      undergoing stem cell transplantation to the palliative care team that specializes in symptom&#xD;
      management can improve the physical and psychological symptoms that patients and families&#xD;
      experience during hospitalization for stem cell transplantation.&#xD;
&#xD;
      The study will use a series of questionnaires to measure participant's and their caregivers'&#xD;
      quality of life, physical symptoms, and mood. Study questionnaires will be completed in the&#xD;
      hospital or clinic with assistance provided as needed&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2</measure>
    <time_frame>week-2</time_frame>
    <description>Compare quality of life (QOL) (FACT-BMT) scores at week-2 (day+5 for autologous, day +8 for myeloablative or reduced intensity allogeneic HSCT) adjusting for baseline QOL scores between the study arms. Score range 0-164 with higher scores indicating better quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FACT-BMT Score at 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>adjusted patient-reported quality of life (QOL) at 3-month adjusting for baseline QOL scores Score range 0-164 with higher scores indicating better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACT-BMT Score at 6 Months</measure>
    <time_frame>6 Months</time_frame>
    <description>compare quality of life between the two study arms at 6 months adjusting for baseline scores Score range 0-164 with higher scores indicating better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>week-2</time_frame>
    <description>compare depression symptoms using HADS at week-2 adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>3 month</time_frame>
    <description>compare depression symptoms using HADS at 3 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>6 months</time_frame>
    <description>Compare depression symptoms using HADS at 6 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>week-2</time_frame>
    <description>compare anxiety symptoms using HADS at week-2 adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>3 months</time_frame>
    <description>compare anxiety symptoms using HADS at 3 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>6 months</time_frame>
    <description>compare anxiety symptoms using HADS at 6 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2</measure>
    <time_frame>week 2</time_frame>
    <description>compare PHQ-9 score at week-2 between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months</measure>
    <time_frame>3-month</time_frame>
    <description>compare PHQ-9 score at 3-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months</measure>
    <time_frame>6-month</time_frame>
    <description>compare PHQ-9 score at 6-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Scores (as Measured by FACT-Fatigue) at Week-2</measure>
    <time_frame>week-2</time_frame>
    <description>examine change in fatigue scores at week-2 adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months</measure>
    <time_frame>3-months</time_frame>
    <description>compare change in fatigue scores at 3 months adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2</measure>
    <time_frame>week-2</time_frame>
    <description>compare symptom burden as measured by Edmonton Symptom Assessment Scale at week-2 adjusting for baseline scores Symptoms burden range is from 0-90 with higher scores indicating higher symptom burden</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months</measure>
    <time_frame>3-months</time_frame>
    <description>Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 3 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months</measure>
    <time_frame>6-months</time_frame>
    <description>Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 6 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Caregiver Quality of Life</measure>
    <time_frame>week-2</time_frame>
    <description>we will use the CareGiver Oncology QOL questionnaire (CarGOQOL) to compare caregiver QOL at week-2 between the study arms caregiver quality of life score ranges from 0-120 with higher scores indicating better caregiver quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>week 2</time_frame>
    <description>compare caregiver depression at week-2 using hospital anxiety and depression scale (HADS) caregiver depression score ranges from 0-21 with higher score indicating higher depression symptoms</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>week 2</time_frame>
    <description>compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Complication of Transplant</condition>
  <arm_group>
    <arm_group_label>Standard transplant care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>transplant with early palliative care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>transplant with early palliative care</intervention_name>
    <description>the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
    <arm_group_label>transplant with early palliative care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients Eligibility Criteria:&#xD;
&#xD;
               -  Adult patients (≥18 years) with hematologic malignancy admitted to Massachusetts&#xD;
                  General Hospital for HSCT are eligible for the study.&#xD;
&#xD;
               -  Ability to speak English or able to complete questionnaires with minimal&#xD;
                  assistance required from an interpreter or family member.&#xD;
&#xD;
          -  Caregivers Eligibility Criteria:&#xD;
&#xD;
               -  Adult caregivers (&gt;18 years) of patients undergoing HSCT at MGH who agreed to&#xD;
                  participate in study.&#xD;
&#xD;
               -  A relative or a friend, identified by the patient who either lives with the&#xD;
                  patient or has in-person contact with him or her at least twice per week.&#xD;
&#xD;
               -  Ability to read questions in English or willing to complete questionnaires with&#xD;
                  the assistance of an interpreter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with prior history of HSCT.&#xD;
&#xD;
          -  Patients undergoing HSCT for a benign hematologic condition (myelodysplastic syndrome&#xD;
             (MDS) is not considered a benign hematologic condition and patients with MDS are&#xD;
             eligible for the study)&#xD;
&#xD;
          -  Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder,&#xD;
             major depression) or other co-morbid disease (dementia, cognitive impairment), which&#xD;
             the treating clinician believes prohibits informed consent or participation in the&#xD;
             study.&#xD;
&#xD;
          -  Patients enrolled on other supportive care intervention trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer S Temel, 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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>August 8, 2018</results_first_submitted>
  <results_first_submitted_qc>March 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 6, 2019</results_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2019</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>Director MGH BMT Survivorship Program</investigator_title>
  </responsible_party>
  <keyword>Hematopoietic stem cell transplantation (HSCT)</keyword>
  <keyword>autologous stem cell transplant</keyword>
  <keyword>allogeneic stem cell transplant</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard Transplant Care</title>
          <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
        </group>
        <group group_id="P2">
          <title>Transplant With Early Palliative Care</title>
          <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week-2</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3-month</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70">6-month</participants>
                <participants group_id="P2" count="71">6-month</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard Transplant Care</title>
          <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
        </group>
        <group group_id="B2">
          <title>Transplant With Early Palliative Care</title>
          <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="79"/>
            <count group_id="B2" value="81"/>
            <count group_id="B3" value="160"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.9" spread="14.1"/>
                    <measurement group_id="B2" value="57.2" spread="12.7"/>
                    <measurement group_id="B3" value="57.1" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2</title>
        <description>Compare quality of life (QOL) (FACT-BMT) scores at week-2 (day+5 for autologous, day +8 for myeloablative or reduced intensity allogeneic HSCT) adjusting for baseline QOL scores between the study arms. Score range 0-164 with higher scores indicating better quality of life</description>
        <time_frame>week-2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2</title>
          <description>Compare quality of life (QOL) (FACT-BMT) scores at week-2 (day+5 for autologous, day +8 for myeloablative or reduced intensity allogeneic HSCT) adjusting for baseline QOL scores between the study arms. Score range 0-164 with higher scores indicating better quality of life</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.60" lower_limit="82" upper_limit="91.20"/>
                    <measurement group_id="O2" value="94.33" lower_limit="89.81" upper_limit="98.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>FACT-BMT Score at 3 Months</title>
        <description>adjusted patient-reported quality of life (QOL) at 3-month adjusting for baseline QOL scores Score range 0-164 with higher scores indicating better quality of life</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>FACT-BMT Score at 3 Months</title>
          <description>adjusted patient-reported quality of life (QOL) at 3-month adjusting for baseline QOL scores Score range 0-164 with higher scores indicating better quality of life</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.66" lower_limit="102.91" upper_limit="110.41"/>
                    <measurement group_id="O2" value="112.00" lower_limit="108.28" upper_limit="115.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>FACT-BMT Score at 6 Months</title>
        <description>compare quality of life between the two study arms at 6 months adjusting for baseline scores Score range 0-164 with higher scores indicating better quality of life</description>
        <time_frame>6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>FACT-BMT Score at 6 Months</title>
          <description>compare quality of life between the two study arms at 6 months adjusting for baseline scores Score range 0-164 with higher scores indicating better quality of life</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.39" lower_limit="105.38" upper_limit="113.41"/>
                    <measurement group_id="O2" value="112.11" lower_limit="108.12" upper_limit="116.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)</title>
        <description>compare depression symptoms using HADS at week-2 adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms</description>
        <time_frame>week-2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)</title>
          <description>compare depression symptoms using HADS at week-2 adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.49" lower_limit="7.59" upper_limit="9.39"/>
                    <measurement group_id="O2" value="6.74" lower_limit="5.86" upper_limit="7.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)</title>
        <description>compare depression symptoms using HADS at 3 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)</title>
          <description>compare depression symptoms using HADS at 3 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.19" lower_limit="4.45" upper_limit="5.93"/>
                    <measurement group_id="O2" value="3.49" lower_limit="2.75" upper_limit="4.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)</title>
        <description>Compare depression symptoms using HADS at 6 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)</title>
          <description>Compare depression symptoms using HADS at 6 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.66" lower_limit="3.93" upper_limit="5.38"/>
                    <measurement group_id="O2" value="3.45" lower_limit="2.70" upper_limit="4.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)</title>
        <description>compare anxiety symptoms using HADS at week-2 adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms</description>
        <time_frame>week-2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)</title>
          <description>compare anxiety symptoms using HADS at week-2 adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.33" lower_limit="5.64" upper_limit="7.02"/>
                    <measurement group_id="O2" value="4.08" lower_limit="3.40" upper_limit="4.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)</title>
        <description>compare anxiety symptoms using HADS at 3 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)</title>
          <description>compare anxiety symptoms using HADS at 3 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.84" lower_limit="4.15" upper_limit="5.53"/>
                    <measurement group_id="O2" value="4.08" lower_limit="3.39" upper_limit="4.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)</title>
        <description>compare anxiety symptoms using HADS at 6 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)</title>
          <description>compare anxiety symptoms using HADS at 6 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.74" lower_limit="3.99" upper_limit="5.49"/>
                    <measurement group_id="O2" value="4.13" lower_limit="3.36" upper_limit="4.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2</title>
        <description>compare PHQ-9 score at week-2 between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression</description>
        <time_frame>week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2</title>
          <description>compare PHQ-9 score at week-2 between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.52" lower_limit="8.42" upper_limit="10.63"/>
                    <measurement group_id="O2" value="8.25" lower_limit="7.16" upper_limit="9.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months</title>
        <description>compare PHQ-9 score at 3-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression</description>
        <time_frame>3-month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months</title>
          <description>compare PHQ-9 score at 3-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.94" lower_limit="5.02" upper_limit="6.86"/>
                    <measurement group_id="O2" value="3.82" lower_limit="2.91" upper_limit="7.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months</title>
        <description>compare PHQ-9 score at 6-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression</description>
        <time_frame>6-month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months</title>
          <description>compare PHQ-9 score at 6-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.58" lower_limit="4.57" upper_limit="6.60"/>
                    <measurement group_id="O2" value="3.95" lower_limit="2.93" upper_limit="4.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fatigue Scores (as Measured by FACT-Fatigue) at Week-2</title>
        <description>examine change in fatigue scores at week-2 adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms</description>
        <time_frame>week-2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Fatigue Scores (as Measured by FACT-Fatigue) at Week-2</title>
          <description>examine change in fatigue scores at week-2 adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.71" lower_limit="21.11" upper_limit="26.31"/>
                    <measurement group_id="O2" value="27.59" lower_limit="25.01" upper_limit="30.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months</title>
        <description>compare change in fatigue scores at 3 months adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms</description>
        <time_frame>3-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months</title>
          <description>compare change in fatigue scores at 3 months adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.60" lower_limit="33.43" upper_limit="37.77"/>
                    <measurement group_id="O2" value="37.60" lower_limit="35.42" upper_limit="39.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2</title>
        <description>compare symptom burden as measured by Edmonton Symptom Assessment Scale at week-2 adjusting for baseline scores Symptoms burden range is from 0-90 with higher scores indicating higher symptom burden</description>
        <time_frame>week-2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2</title>
          <description>compare symptom burden as measured by Edmonton Symptom Assessment Scale at week-2 adjusting for baseline scores Symptoms burden range is from 0-90 with higher scores indicating higher symptom burden</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.74" lower_limit="34.09" upper_limit="41.40"/>
                    <measurement group_id="O2" value="31.49" lower_limit="27.79" upper_limit="35.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months</title>
        <description>Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 3 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms</description>
        <time_frame>3-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months</title>
          <description>Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 3 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.79" lower_limit="23.79" upper_limit="27.79"/>
                    <measurement group_id="O2" value="21.44" lower_limit="19.53" upper_limit="23.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months</title>
        <description>Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 6 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms</description>
        <time_frame>6-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months</title>
          <description>Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 6 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.18" lower_limit="23.96" upper_limit="28.39"/>
                    <measurement group_id="O2" value="22.15" lower_limit="19.91" upper_limit="24.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Caregiver Quality of Life</title>
        <description>we will use the CareGiver Oncology QOL questionnaire (CarGOQOL) to compare caregiver QOL at week-2 between the study arms caregiver quality of life score ranges from 0-120 with higher scores indicating better caregiver quality of life</description>
        <time_frame>week-2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver Quality of Life</title>
          <description>we will use the CareGiver Oncology QOL questionnaire (CarGOQOL) to compare caregiver QOL at week-2 between the study arms caregiver quality of life score ranges from 0-120 with higher scores indicating better caregiver quality of life</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.32" lower_limit="107.79" upper_limit="118.85"/>
                    <measurement group_id="O2" value="118.71" lower_limit="114.40" upper_limit="123.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)</title>
        <description>compare caregiver depression at week-2 using hospital anxiety and depression scale (HADS) caregiver depression score ranges from 0-21 with higher score indicating higher depression symptoms</description>
        <time_frame>week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)</title>
          <description>compare caregiver depression at week-2 using hospital anxiety and depression scale (HADS) caregiver depression score ranges from 0-21 with higher score indicating higher depression symptoms</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="4.51" upper_limit="7.49"/>
                    <measurement group_id="O2" value="4.05" lower_limit="3.01" upper_limit="5.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)</title>
        <description>compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS)</description>
        <time_frame>week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Transplant Care</title>
            <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
          </group>
          <group group_id="O2">
            <title>Transplant With Early Palliative Care</title>
            <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)</title>
          <description>compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.54" lower_limit="5.09" upper_limit="7.99"/>
                    <measurement group_id="O2" value="6.24" lower_limit="5.10" upper_limit="7.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>this is a supportive care trial. there are no adverse events that have been observed</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard Transplant Care</title>
          <description>Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)&#xD;
-- Complete baseline data collection, and registration&#xD;
Patient Randomization&#xD;
Standard transplant oncology care&#xD;
-- Palliative care consults only upon request&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT</description>
        </group>
        <group group_id="E2">
          <title>Transplant With Early Palliative Care</title>
          <description>Standard transplant oncology care with early palliative care&#xD;
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)&#xD;
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits&#xD;
Longitudinal Data Collection (patient &amp; family caregivers)&#xD;
Week-2 of hospitalization&#xD;
3-months, and 6-months post HSCT&#xD;
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Areej El-Jawahri</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-724-4000</phone>
      <email>ael-jawahri@partners.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02207322
org study id: 14-241
nct id: NCT02207322
lead sponsor: 
has dmc: Yes
The main purpose of this study is to assess whether early integration of palliative and
      supportive care services in care of patients hospitalized for hematopoietic stem cell
      transplantation (HSCT) can improve patients' and family caregivers' quality of life and mood.
This research study is evaluating the impact of early involvement of supportive care team
      working with the transplant oncology team will have on the quality of life, symptoms, and
      mood of patients undergoing stem cell transplantation.

      The purpose of this research study is to find out whether introducing patients and families
      undergoing stem cell transplantation to the palliative care team that specializes in symptom
      management can improve the physical and psychological symptoms that patients and families
      experience during hospitalization for stem cell transplantation.

      The study will use a series of questionnaires to measure participant's and their caregivers'
      quality of life, physical symptoms, and mood. Study questionnaires will be completed in the
      hospital or clinic with assistance provided as needed
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2
time frame: week-2
description: Compare quality of life (QOL) (FACT-BMT) scores at week-2 (day+5 for autologous, day +8 for myeloablative or reduced intensity allogeneic HSCT) adjusting for baseline QOL scores between the study arms. Score range 0-164 with higher scores indicating better quality of life
measure: FACT-BMT Score at 3 Months
time frame: 3 months
description: adjusted patient-reported quality of life (QOL) at 3-month adjusting for baseline QOL scores Score range 0-164 with higher scores indicating better quality of life
measure: FACT-BMT Score at 6 Months
time frame: 6 Months
description: compare quality of life between the two study arms at 6 months adjusting for baseline scores Score range 0-164 with higher scores indicating better quality of life
measure: Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
time frame: week-2
description: compare depression symptoms using HADS at week-2 adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms
measure: Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)
time frame: 3 month
description: compare depression symptoms using HADS at 3 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms
measure: Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)
time frame: 6 months
description: Compare depression symptoms using HADS at 6 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms
measure: Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
time frame: week-2
description: compare anxiety symptoms using HADS at week-2 adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms
measure: Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)
time frame: 3 months
description: compare anxiety symptoms using HADS at 3 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms
measure: Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)
time frame: 6 months
description: compare anxiety symptoms using HADS at 6 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms
measure: Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2
time frame: week 2
description: compare PHQ-9 score at week-2 between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression
measure: Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months
time frame: 3-month
description: compare PHQ-9 score at 3-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression
measure: Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months
time frame: 6-month
description: compare PHQ-9 score at 6-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression
measure: Fatigue Scores (as Measured by FACT-Fatigue) at Week-2
time frame: week-2
description: examine change in fatigue scores at week-2 adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms
measure: Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months
time frame: 3-months
description: compare change in fatigue scores at 3 months adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms
measure: Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2
time frame: week-2
description: compare symptom burden as measured by Edmonton Symptom Assessment Scale at week-2 adjusting for baseline scores Symptoms burden range is from 0-90 with higher scores indicating higher symptom burden
measure: Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months
time frame: 3-months
description: Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 3 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms
measure: Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months
time frame: 6-months
description: Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 6 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms
measure: Caregiver Quality of Life
time frame: week-2
description: we will use the CareGiver Oncology QOL questionnaire (CarGOQOL) to compare caregiver QOL at week-2 between the study arms caregiver quality of life score ranges from 0-120 with higher scores indicating better caregiver quality of life
measure: Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)
time frame: week 2
description: compare caregiver depression at week-2 using hospital anxiety and depression scale (HADS) caregiver depression score ranges from 0-21 with higher score indicating higher depression symptoms
measure: Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)
time frame: week 2
description: compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS)
arm group label: Standard transplant care
arm group type: No Intervention
description: Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)
-- Complete baseline data collection, and registration
Patient Randomization
Standard transplant oncology care
-- Palliative care consults only upon request
Longitudinal Data Collection (patient & family caregivers)
Week-2 of hospitalization
3-months, and 6-months post HSCT
arm group label: transplant with early palliative care
arm group type: Experimental
description: Standard transplant oncology care with early palliative care
Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits
Longitudinal Data Collection (patient & family caregivers)
Week-2 of hospitalization
3-months, and 6-months post HSCT
intervention type: Other
intervention name: transplant with early palliative care
description: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation
arm group label: transplant with early palliative care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer S Temel, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: El-Jawahri, Areej,M.D.
investigator title: Director MGH BMT Survivorship Program
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 