<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/NCT04423848</url>
  </required_header>
  <id_info>
    <org_study_id>19-613</org_study_id>
    <nct_id>NCT04423848</nct_id>
  </id_info>
  <brief_title>Home Hospital for Lymphoma</brief_title>
  <official_title>Supportive Oncology Care at Home Intervention for Patients With Lymphoma</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research is to evaluate an intervention, which the investigators call &quot;Home&#xD;
      Hospital for Lymphoma,&quot; that involves remote patient monitoring and home-based supportive&#xD;
      care for patients hospitalized with lymphoma at Massachusetts General Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study is a single arm pilot Feasibility Study, which is the first-time&#xD;
      investigators are examining this hospital at home intervention for patients with lymphoma.&#xD;
&#xD;
      The research study procedures include screening for eligibility, questionnaires, remote&#xD;
      patient monitoring (e.g. patient-reported symptoms and home monitored vital signs) and&#xD;
      home-based supportive care (e.g. visits to patients' homes to address and manage any&#xD;
      concerning issues identified), and interviews of participants, caregivers, and clinicians&#xD;
      asking their perceptions of the Home Hospital for Lymphoma program.&#xD;
&#xD;
      Participants will include 3 groups:&#xD;
&#xD;
      Enrolled participants receiving the hospital at home intervention, caregivers of&#xD;
      participants, and clinicians.&#xD;
&#xD;
      Participants will be in the research study for about six months after consent. It is expected&#xD;
      that up to 38 participants will take part in this research study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study halted prematurely and will not resume due to poor accrual.&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>enrollment rate</measure>
    <time_frame>1 year</time_frame>
    <description>The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>retention rate</measure>
    <time_frame>1 year</time_frame>
    <description>The primary endpoint is feasibility. The proposed intervention will be deemed feasible if those enrolled patients complete at least 60% of daily patient-reported symptom assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of the intervention</measure>
    <time_frame>1 year</time_frame>
    <description>Qualitative acceptability ratings from patients, caregivers, and clinicians obtained via exit individual interviews regarding acceptability (i.e. usefulness, effectiveness, and relevance of the intervention) from patients, family caregivers, and clinicians. The intervention will be deemed acceptable if ≥ 60% of patients, family caregivers, and clinicians report that the intervention was helpful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of completion of daily vital signs</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of participants that complete daily reporting of vital signs during their home hospital admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Adverse Events</measure>
    <time_frame>1 year</time_frame>
    <description>The rates of Adverse Events and Serious Adverse Events that are judged by the treating lymphoma clinician to be at least possibly related to the study intervention.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r)</measure>
    <time_frame>1 year</time_frame>
    <description>Change in participants' symptom burden as measured by the ESAS-r throughout the study. The ESAS-r ranges 0-10 for each symptom with higher scores indicating worse symptom burden.</description>
  </other_outcome>
  <other_outcome>
    <measure>Psychological distress (Hospital Anxiety and Depression Scale - HADS)</measure>
    <time_frame>1 year</time_frame>
    <description>Change in psychological distress as measured by the HADS, with subscale ranges from 0-21 with higher scores indicating worse psychological distress.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life (Functional Assessment of Cancer Therapy-General - FACT-G)</measure>
    <time_frame>1 year</time_frame>
    <description>Change in quality of life as measured by the FACT-G throughout the study, with range of 0-108 and higher scores indicating better quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of home hospital admission</measure>
    <time_frame>1 year</time_frame>
    <description>Number of days the participant receives home hospital care through the home hospital program.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of home visits</measure>
    <time_frame>1 year</time_frame>
    <description>Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to participants at their home.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of phone calls</measure>
    <time_frame>1 year</time_frame>
    <description>Number of phone calls required per participants as well as the average duration of these calls.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of urgent visits</measure>
    <time_frame>1 year</time_frame>
    <description>The number of urgent visits to clinic per participant and the proportion of participants who have an urgent visit to clinic.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of emergency department (ED) visits The number of imaging tests ordered during home hospital admission</measure>
    <time_frame>1 year</time_frame>
    <description>The number of emergency department (ED) visits per participant and the proportion of participants who have an ED visit.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of hospital readmissions</measure>
    <time_frame>1 year</time_frame>
    <description>The number of hospital readmissions in 30 days per participant and the proportion of participants who have a hospital readmission within 30 days.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of imaging studies</measure>
    <time_frame>1 year</time_frame>
    <description>The number of imaging studies obtained per participant during the Home Hospital admission.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>Home Hospital for Lymphoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Home Hospital for Lymphoma intervention entails the following: patient-reported symptoms and vital signs with appropriate triggers for phone calls and home visits, and regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Hospital for Lymphoma</intervention_name>
    <description>Remote monitoring and home-based care designed for hospitalized patients with lymphoma</description>
    <arm_group_label>Home Hospital for Lymphoma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Receiving their lymphoma care with curative intent at MGH (treatment intent based upon&#xD;
             chemotherapy order in the electronic medical record)&#xD;
&#xD;
          -  Hemodynamically stable during the first 24 hours of hospital admission at MGH&#xD;
&#xD;
          -  Residing within the designated geographic area for MGH Home Hospital Service (an&#xD;
             approximately 10-mile radius from MGH)&#xD;
&#xD;
          -  Able to communicate and respond to questionnaires in English&#xD;
&#xD;
          -  Lives with a family member or a friend who supports the patient at home&#xD;
&#xD;
          -  Deemed eligible for supportive oncology care at home based on the MGH Home Hospital&#xD;
             clinician evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those admitted to the intensive care unit&#xD;
&#xD;
          -  Have high oxygen requirement (FIO2 &gt; 0.4)&#xD;
&#xD;
          -  Experience active angina or cardiac arrythmias&#xD;
&#xD;
          -  Have a planned inpatient surgical or interventional procedure&#xD;
&#xD;
          -  Have uncontrolled psychiatric illness or impaired cognition that prohibits complying&#xD;
             with the study procedures&#xD;
&#xD;
          -  Have uncontrolled pain requiring intravenous pain medications&#xD;
&#xD;
          -  Those deemed ineligible based on the Home Hospital Service clinician evaluation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Areej El-Jawahri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</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>October 2022</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Lymphoma</keyword>
  <keyword>Home Care Services, Hospital-Based</keyword>
  <keyword>Cancer Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
    <ipd_access_criteria>Contact the Partners Innovations team at http://www.partners.org/innovation</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04423848
org study id: 19-613
nct id: NCT04423848
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research is to evaluate an intervention, which the investigators call "Home
      Hospital for Lymphoma," that involves remote patient monitoring and home-based supportive
      care for patients hospitalized with lymphoma at Massachusetts General Hospital.
This research study is a single arm pilot Feasibility Study, which is the first-time
      investigators are examining this hospital at home intervention for patients with lymphoma.

      The research study procedures include screening for eligibility, questionnaires, remote
      patient monitoring (e.g. patient-reported symptoms and home monitored vital signs) and
      home-based supportive care (e.g. visits to patients' homes to address and manage any
      concerning issues identified), and interviews of participants, caregivers, and clinicians
      asking their perceptions of the Home Hospital for Lymphoma program.

      Participants will include 3 groups:

      Enrolled participants receiving the hospital at home intervention, caregivers of
      participants, and clinicians.

      Participants will be in the research study for about six months after consent. It is expected
      that up to 38 participants will take part in this research study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: enrollment rate
time frame: 1 year
description: The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study
measure: retention rate
time frame: 1 year
description: The primary endpoint is feasibility. The proposed intervention will be deemed feasible if those enrolled patients complete at least 60% of daily patient-reported symptom assessment.
measure: Acceptability of the intervention
time frame: 1 year
description: Qualitative acceptability ratings from patients, caregivers, and clinicians obtained via exit individual interviews regarding acceptability (i.e. usefulness, effectiveness, and relevance of the intervention) from patients, family caregivers, and clinicians. The intervention will be deemed acceptable if ≥ 60% of patients, family caregivers, and clinicians report that the intervention was helpful.
measure: Rates of completion of daily vital signs
time frame: 1 year
description: Proportion of participants that complete daily reporting of vital signs during their home hospital admission.
measure: Rates of Adverse Events
time frame: 1 year
description: The rates of Adverse Events and Serious Adverse Events that are judged by the treating lymphoma clinician to be at least possibly related to the study intervention.
measure: Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r)
time frame: 1 year
description: Change in participants' symptom burden as measured by the ESAS-r throughout the study. The ESAS-r ranges 0-10 for each symptom with higher scores indicating worse symptom burden.
measure: Psychological distress (Hospital Anxiety and Depression Scale - HADS)
time frame: 1 year
description: Change in psychological distress as measured by the HADS, with subscale ranges from 0-21 with higher scores indicating worse psychological distress.
measure: Quality of life (Functional Assessment of Cancer Therapy-General - FACT-G)
time frame: 1 year
description: Change in quality of life as measured by the FACT-G throughout the study, with range of 0-108 and higher scores indicating better quality of life.
measure: Length of home hospital admission
time frame: 1 year
description: Number of days the participant receives home hospital care through the home hospital program.
measure: Number of home visits
time frame: 1 year
description: Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to participants at their home.
measure: Number of phone calls
time frame: 1 year
description: Number of phone calls required per participants as well as the average duration of these calls.
measure: Number of urgent visits
time frame: 1 year
description: The number of urgent visits to clinic per participant and the proportion of participants who have an urgent visit to clinic.
measure: Number of emergency department (ED) visits The number of imaging tests ordered during home hospital admission
time frame: 1 year
description: The number of emergency department (ED) visits per participant and the proportion of participants who have an ED visit.
measure: Number of hospital readmissions
time frame: 1 year
description: The number of hospital readmissions in 30 days per participant and the proportion of participants who have a hospital readmission within 30 days.
measure: Number of imaging studies
time frame: 1 year
description: The number of imaging studies obtained per participant during the Home Hospital admission.
arm group label: Home Hospital for Lymphoma
arm group type: Experimental
description: The Home Hospital for Lymphoma intervention entails the following: patient-reported symptoms and vital signs with appropriate triggers for phone calls and home visits, and regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.
intervention type: Other
intervention name: Home Hospital for Lymphoma
description: Remote monitoring and home-based care designed for hospitalized patients with lymphoma
arm group label: Home Hospital for Lymphoma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Areej El-Jawahri, 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: Principal Investigator
mesh term: Lymphoma
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication
ipd access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation