<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/NCT03040102</url>
  </required_header>
  <id_info>
    <org_study_id>17-026</org_study_id>
    <nct_id>NCT03040102</nct_id>
  </id_info>
  <brief_title>Randomized Study of a Hospice Video Educational Tool for Patients With Advanced Cancer and Their Caregivers</brief_title>
  <official_title>Randomized Study of a Hospice Video Educational Tool for Patients With Advanced Cancer and Their Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gordon and Betty Moore Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to compare two ways to educate patients with cancer and&#xD;
      their caregivers about hospice care services&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research study is to compare two ways to educate patients with cancer and&#xD;
      their caregivers about hospice care services - a video educational tool or a verbal&#xD;
      narrative. The study will assess the effect of these methods on patients' and caregivers'&#xD;
      knowledge about hospice care, as well as their perceptions and preferences for this service.&#xD;
&#xD;
      Using this research, the investigators hope to find out the best way to help patients and&#xD;
      their loved ones better understand hospice care. The educational methods used in this study&#xD;
      (the video educational tool or verbal narrative) are meant to serve as an introduction to&#xD;
      hospice care. Further details about hospice should be discussed directly with your care team.&#xD;
&#xD;
      This study will enroll 150 patients with advanced cancer and up to 150 of their caregivers in&#xD;
      this randomized clinical trial. The study will use questionnaires to measure the participant&#xD;
      and the caregivers' knowledge of hospice care, as well as your perceptions and preferences&#xD;
      for these services. Study assessments will be completed before and after watching the video&#xD;
      or hearing the verbal narrative in the hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2017</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Preference for Hospice Question</measure>
    <time_frame>immediately after the video intervention or verbal narrative</time_frame>
    <description>We will ask patients whether they would prefer to receive hospice care at the end of life (yes vs. no)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient knowledge about hospice Questionnaire</measure>
    <time_frame>immediately after the video intervention or verbal narrative</time_frame>
    <description>we will assess knowledge about hospice using 10 knowledge questions</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Perception of Hospice Care Questionnaire</measure>
    <time_frame>immediately after the video intervention or verbal narrative</time_frame>
    <description>we will assess perception of hospice using the Hospice Perception Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Hospice Utilization</measure>
    <time_frame>1 year after study completion</time_frame>
    <description>We will assess patient hospice utilization and length of stay in hospice</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregiver Preference for Hospice Question</measure>
    <time_frame>immediately after the video intervention or verbal narrative</time_frame>
    <description>we will assess caregiver's preference for their loved one using hospice (yes vs. no)</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregiver Knowledge about Hospice Questionnaire</measure>
    <time_frame>immediately after the video intervention or verbal narrative</time_frame>
    <description>we will assess knowledge about hospice using 10 knowledge questions</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregiver Perception of Hospice Care Questionnaire</measure>
    <time_frame>immediately after the video intervention or verbal narrative</time_frame>
    <description>we will assess perception of hospice using the Hospice Perception Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregiver satisfaction with end-of-life care (FAMCARE)</measure>
    <time_frame>1 year after study completion</time_frame>
    <description>We will use 9 items from the FAMCARE to assess caregivers' satisfaction with patient's end of life care</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Hospice Video Educational Tool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The hospice video educational tool is a 6 minute video&#xD;
Participants will watch an approximately 6-minute digital video regarding hospice on an iPad</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hospice Verbal Narrative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The RA will read a verbal narrative that is identical to the narrative of the video to participants&#xD;
Standard of Care practice is used</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hospice Video Educational Tool</intervention_name>
    <description>it's a 6 minute video regarding hospice care</description>
    <arm_group_label>Hospice Video Educational Tool</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of Care practice is used</description>
    <arm_group_label>Hospice Verbal Narrative</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients Eligibility Criteria:&#xD;
&#xD;
          -  Adult patients (≥18 years) with a diagnosis of metastatic solid cancer.&#xD;
&#xD;
          -  A prognosis of 12 months or less based on the treating oncologist's assessment.&#xD;
&#xD;
          -  The ability to provide informed consent.&#xD;
&#xD;
          -  Ability to comprehend and speak English.&#xD;
&#xD;
        Caregivers Eligibility Criteria:&#xD;
&#xD;
          -  Adult caregivers (&gt;18 years) of patients who have agreed to participate in study.&#xD;
&#xD;
          -  A relative or a friend upon whom the patient relies for help and who will be likely to&#xD;
             be present during hospitalization, or willing to participate by phone.&#xD;
&#xD;
          -  Ability to comprehend and speak English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients Exclusion Criteria:&#xD;
&#xD;
        -Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major&#xD;
        depression) or other co-morbid disease (dementia, cognitive impairment), which the treating&#xD;
        clinician believes prohibits the ability to participate in study procedures&#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>Areej El-Jawahri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts general Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 28, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>August 28, 2022</last_update_submitted>
  <last_update_submitted_qc>August 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 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>Areej El-Jawahri, MD</investigator_title>
  </responsible_party>
  <keyword>Advanced Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040102
org study id: 17-026
nct id: NCT03040102
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to compare two ways to educate patients with cancer and
      their caregivers about hospice care services
The purpose of this research study is to compare two ways to educate patients with cancer and
      their caregivers about hospice care services - a video educational tool or a verbal
      narrative. The study will assess the effect of these methods on patients' and caregivers'
      knowledge about hospice care, as well as their perceptions and preferences for this service.

      Using this research, the investigators hope to find out the best way to help patients and
      their loved ones better understand hospice care. The educational methods used in this study
      (the video educational tool or verbal narrative) are meant to serve as an introduction to
      hospice care. Further details about hospice should be discussed directly with your care team.

      This study will enroll 150 patients with advanced cancer and up to 150 of their caregivers in
      this randomized clinical trial. The study will use questionnaires to measure the participant
      and the caregivers' knowledge of hospice care, as well as your perceptions and preferences
      for these services. Study assessments will be completed before and after watching the video
      or hearing the verbal narrative in the hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient Preference for Hospice Question
time frame: immediately after the video intervention or verbal narrative
description: We will ask patients whether they would prefer to receive hospice care at the end of life (yes vs. no)
measure: Patient knowledge about hospice Questionnaire
time frame: immediately after the video intervention or verbal narrative
description: we will assess knowledge about hospice using 10 knowledge questions
measure: Patient Perception of Hospice Care Questionnaire
time frame: immediately after the video intervention or verbal narrative
description: we will assess perception of hospice using the Hospice Perception Questionnaire
measure: Patient Hospice Utilization
time frame: 1 year after study completion
description: We will assess patient hospice utilization and length of stay in hospice
measure: Caregiver Preference for Hospice Question
time frame: immediately after the video intervention or verbal narrative
description: we will assess caregiver's preference for their loved one using hospice (yes vs. no)
measure: Caregiver Knowledge about Hospice Questionnaire
time frame: immediately after the video intervention or verbal narrative
description: we will assess knowledge about hospice using 10 knowledge questions
measure: Caregiver Perception of Hospice Care Questionnaire
time frame: immediately after the video intervention or verbal narrative
description: we will assess perception of hospice using the Hospice Perception Questionnaire
measure: Caregiver satisfaction with end-of-life care (FAMCARE)
time frame: 1 year after study completion
description: We will use 9 items from the FAMCARE to assess caregivers' satisfaction with patient's end of life care
arm group label: Hospice Video Educational Tool
arm group type: Experimental
description: The hospice video educational tool is a 6 minute video
Participants will watch an approximately 6-minute digital video regarding hospice on an iPad
arm group label: Hospice Verbal Narrative
arm group type: Active Comparator
description: The RA will read a verbal narrative that is identical to the narrative of the video to participants
Standard of Care practice is used
intervention type: Other
intervention name: Hospice Video Educational Tool
description: it's a 6 minute video regarding hospice care
arm group label: Hospice Video Educational Tool
intervention type: Other
intervention name: Standard of Care
description: Standard of Care practice is used
arm group label: Hospice Verbal Narrative
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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: Areej El-Jawahri, MD
mesh term: Neoplasms
sharing ipd: No