<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/NCT03824158</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19080337</org_study_id>
    <secondary_id>1R01CA235730-01</secondary_id>
    <nct_id>NCT03824158</nct_id>
  </id_info>
  <brief_title>Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial</brief_title>
  <official_title>Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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 overall goal of this study is to identify the most effective and efficient advance care&#xD;
      planning (ACP) strategy for patients with advanced cancer.&#xD;
&#xD;
      The specific aims are to:&#xD;
&#xD;
      Aim 1. Compare the effectiveness of in-person, facilitated ACP versus web-based ACP on&#xD;
      patient and family caregiver outcomes.&#xD;
&#xD;
      Aim 2. Assess implementation costs and the effects of in-person, facilitated ACP and&#xD;
      web-based ACP on healthcare utilization at end of life.&#xD;
&#xD;
      Aim 3. Identify contexts and mechanisms that influence the effectiveness of in-person,&#xD;
      facilitated ACP versus web-based ACP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study investigators will conduct a single-blind, patient-level randomized trial to compare&#xD;
      the effectiveness of two different patient-facing advance care planning (ACP) interventions.&#xD;
      Investigators will enroll 400 patients with advanced cancer and their family caregivers to&#xD;
      receive either (1) in-person discussions with trained facilitators or (2) web-based ACP using&#xD;
      interactive videos. Because these approaches have never been compared directly, it is unclear&#xD;
      whether one form of advance care planning is more potent, and if so, for whom and under what&#xD;
      circumstances.&#xD;
&#xD;
      Aim 1 compares the effectiveness of in-person, facilitated ACP versus web-based ACP on&#xD;
      patient and family caregiver outcomes (ACP engagement, ACP discussions, advance directive&#xD;
      completion, goal attainment, and caregiver psychological symptoms). Aim 2 assesses&#xD;
      implementation costs of each intervention and effects on healthcare utilization at end of&#xD;
      life. Aim 3 identifies contexts and mechanisms influencing the effectiveness of each&#xD;
      approach. Primary patient outcomes will be assessed at 12 weeks. Participants will be&#xD;
      followed until 12 weeks after the patient's death or completion of the 48-month data&#xD;
      collection period, whichever occurs first. In-depth interviews with patients, caregivers, and&#xD;
      clinicians will begin in Year 2 of the grant and continue until thematic saturation is&#xD;
      reached.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Advance care planning engagement</measure>
    <time_frame>12 weeks</time_frame>
    <description>15-item ACP engagement survey assesses ACP processes related to choosing a medical decision maker, discussing and documenting preference for care at end of life, flexibility for surrogate decision making, and asking questions of medical providers. A single summary score will be reported (range 0-5 with higher scores indicating higher engagement).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>advance care planning discussions with caregivers</measure>
    <time_frame>12 weeks</time_frame>
    <description>&quot;Has [participant] talked with [participant's] family or friends about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>advance care planning discussions with physicians</measure>
    <time_frame>12 weeks</time_frame>
    <description>&quot;Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>advance directive completion</measure>
    <time_frame>12 weeks</time_frame>
    <description>&quot;Has [participant] completed a living will or advance directive?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>documented care goals</measure>
    <time_frame>12 weeks</time_frame>
    <description>Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of goal-concordant end-of-life care - patient wishes followed</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>Bereaved caregivers will be asked &quot;In [participant's] opinion, to what extent were [the patient's] wishes followed in the medical care received in the last month of life?&quot; Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that &quot;followed patients' wishes a great deal.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of goal-concordant end-of-life care - place of death</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>Bereaved caregivers will be asked about patient's preferred and actual places of death, with questions separated in the survey to minimize conscious comparison. Receipt of goal-concordant end-of-life care - place of death will be defined as patients dying in their preferred location.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of end-of-life care</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>13-item Caregiver Evaluation of Quality of End-of-Life Care (CEQUEL) scale. A single summary score will be reported (range of scores 13-26, with higher scores indicating better perceived quality of care).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>caregiver depression symptoms</measure>
    <time_frame>12 weeks and bereavement up to 60 months</time_frame>
    <description>Depression subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver depression symptoms at 12 weeks and bereavement. The HADS depression subscale scores range from 0 to 21, with higher scores indicating more distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>caregiver anxiety symptoms</measure>
    <time_frame>12 weeks and during bereavement, up to 60 months</time_frame>
    <description>Anxiety subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver anxiety symptoms at 12 weeks and bereavement. The anxiety subscale scores range from 0 to 21, with higher scores indicating more distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>caregiver post-traumatic stress symptoms</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>22-item Impact of Events Scale-revised has a scoring range from 0-88, with higher scores indicating more post-traumatic stress symptoms.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Healthcare utilization at end of life - chemotherapy</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>Investigators will measure whether chemotherapy was administered within the last 2 weeks of life (Y/N)</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare utilization at end of life - ICU</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>Investigators will measure whether participant was admitted to the intensive care unit in the last 30 days of life (Y/N)</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare utilization at end of life - hospice</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>Investigators will measure whether the participant was admitted to hospice (Y/N)</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare utilization at end of life - hospice &lt; 3 days</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>Investigators will measure whether the participant was admitted to hospice for &lt; 3 days (Y/N)</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare utilization at end of life - hospice length of stay</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>For participants admitted to hospice, investigators will measure number of days in hospice.</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare utilization at end of life - hospitalizations</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>Investigators will measure number of hospitalizations in the last month of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare utilization at end of life - ED visits</measure>
    <time_frame>during bereavement, up to 60 months</time_frame>
    <description>Investigators will measure number of emergency department visits in the last month of life</description>
  </other_outcome>
  <other_outcome>
    <measure>advance care planning implementation costs</measure>
    <time_frame>through study completion, up to 5 years</time_frame>
    <description>Investigators will assess advance care planning implementation costs by tracking staff time spent on each intervention arm. Staff time costs for each intervention will be estimated by multiplying staff training and patient care time related to the intervention in hours by the average hourly wage for US nursing and social work staff of comparable levels.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Cancer</condition>
  <condition>Advance Care Planning</condition>
  <arm_group>
    <arm_group_label>Facilitated advance care planning (in-person or telephonic)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Web-based advance care planning</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to this arm will participate in web-based ACP via the PREPARE website.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Facilitated advance care planning (in-person or telephonic)</intervention_name>
    <description>The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences.</description>
    <arm_group_label>Facilitated advance care planning (in-person or telephonic)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Web-based advance care planning</intervention_name>
    <description>Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.</description>
    <arm_group_label>Web-based advance care planning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Solid tumor&#xD;
&#xD;
          3. The oncologist &quot;would not be surprised&quot; if the patient died within the next year&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2&#xD;
&#xD;
          5. Planning to receive ongoing care at a participating oncology clinic&#xD;
&#xD;
          6. Willing to participate in either a web-based or facilitated program&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
          1. Does not speak English&#xD;
&#xD;
          2. Inability to consent, using a validated teach-back method&#xD;
&#xD;
          3. Hematologic malignancy&#xD;
&#xD;
          4. No phone for additional study contacts and follow-up interviews&#xD;
&#xD;
          5. Unable to participate in advance care planning, as assessed by clinician&#xD;
&#xD;
          6. Unable to complete the baseline interview&#xD;
&#xD;
        Patients will be able to identify and enroll a caregiver, designated by the patient as the&#xD;
        primary family member or friend involved in their care and best able to participate in the&#xD;
        study.&#xD;
&#xD;
        Caregiver Inclusion criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Family member or friend of an eligible patient&#xD;
&#xD;
          3. Primary person involved in patient's care and best able to participate in the study,&#xD;
             as assessed by patient&#xD;
&#xD;
        Caregiver Exclusion criteria:&#xD;
&#xD;
          1. Does not speak English&#xD;
&#xD;
          2. No phone for additional study contacts and follow-up interviews&#xD;
&#xD;
          3. Unable to complete the baseline interview&#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>Yael Schenker, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Yael Schenker, MD, MAS</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>cancer, advance care planning</keyword>
  <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/NCT03824158
org study id: STUDY19080337
secondary id: 1R01CA235730-01
nct id: NCT03824158
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal of this study is to identify the most effective and efficient advance care
      planning (ACP) strategy for patients with advanced cancer.

      The specific aims are to:

      Aim 1. Compare the effectiveness of in-person, facilitated ACP versus web-based ACP on
      patient and family caregiver outcomes.

      Aim 2. Assess implementation costs and the effects of in-person, facilitated ACP and
      web-based ACP on healthcare utilization at end of life.

      Aim 3. Identify contexts and mechanisms that influence the effectiveness of in-person,
      facilitated ACP versus web-based ACP.
Study investigators will conduct a single-blind, patient-level randomized trial to compare
      the effectiveness of two different patient-facing advance care planning (ACP) interventions.
      Investigators will enroll 400 patients with advanced cancer and their family caregivers to
      receive either (1) in-person discussions with trained facilitators or (2) web-based ACP using
      interactive videos. Because these approaches have never been compared directly, it is unclear
      whether one form of advance care planning is more potent, and if so, for whom and under what
      circumstances.

      Aim 1 compares the effectiveness of in-person, facilitated ACP versus web-based ACP on
      patient and family caregiver outcomes (ACP engagement, ACP discussions, advance directive
      completion, goal attainment, and caregiver psychological symptoms). Aim 2 assesses
      implementation costs of each intervention and effects on healthcare utilization at end of
      life. Aim 3 identifies contexts and mechanisms influencing the effectiveness of each
      approach. Primary patient outcomes will be assessed at 12 weeks. Participants will be
      followed until 12 weeks after the patient's death or completion of the 48-month data
      collection period, whichever occurs first. In-depth interviews with patients, caregivers, and
      clinicians will begin in Year 2 of the grant and continue until thematic saturation is
      reached.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Advance care planning engagement
time frame: 12 weeks
description: 15-item ACP engagement survey assesses ACP processes related to choosing a medical decision maker, discussing and documenting preference for care at end of life, flexibility for surrogate decision making, and asking questions of medical providers. A single summary score will be reported (range 0-5 with higher scores indicating higher engagement).
measure: advance care planning discussions with caregivers
time frame: 12 weeks
description: "Has [participant] talked with [participant's] family or friends about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"
measure: advance care planning discussions with physicians
time frame: 12 weeks
description: "Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"
measure: advance directive completion
time frame: 12 weeks
description: "Has [participant] completed a living will or advance directive?"
measure: documented care goals
time frame: 12 weeks
description: Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No).
measure: Receipt of goal-concordant end-of-life care - patient wishes followed
time frame: during bereavement, up to 60 months
description: Bereaved caregivers will be asked "In [participant's] opinion, to what extent were [the patient's] wishes followed in the medical care received in the last month of life?" Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that "followed patients' wishes a great deal."
measure: Receipt of goal-concordant end-of-life care - place of death
time frame: during bereavement, up to 60 months
description: Bereaved caregivers will be asked about patient's preferred and actual places of death, with questions separated in the survey to minimize conscious comparison. Receipt of goal-concordant end-of-life care - place of death will be defined as patients dying in their preferred location.
measure: quality of end-of-life care
time frame: during bereavement, up to 60 months
description: 13-item Caregiver Evaluation of Quality of End-of-Life Care (CEQUEL) scale. A single summary score will be reported (range of scores 13-26, with higher scores indicating better perceived quality of care).
measure: caregiver depression symptoms
time frame: 12 weeks and bereavement up to 60 months
description: Depression subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver depression symptoms at 12 weeks and bereavement. The HADS depression subscale scores range from 0 to 21, with higher scores indicating more distress.
measure: caregiver anxiety symptoms
time frame: 12 weeks and during bereavement, up to 60 months
description: Anxiety subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver anxiety symptoms at 12 weeks and bereavement. The anxiety subscale scores range from 0 to 21, with higher scores indicating more distress.
measure: caregiver post-traumatic stress symptoms
time frame: during bereavement, up to 60 months
description: 22-item Impact of Events Scale-revised has a scoring range from 0-88, with higher scores indicating more post-traumatic stress symptoms.
measure: Healthcare utilization at end of life - chemotherapy
time frame: during bereavement, up to 60 months
description: Investigators will measure whether chemotherapy was administered within the last 2 weeks of life (Y/N)
measure: Healthcare utilization at end of life - ICU
time frame: during bereavement, up to 60 months
description: Investigators will measure whether participant was admitted to the intensive care unit in the last 30 days of life (Y/N)
measure: Healthcare utilization at end of life - hospice
time frame: during bereavement, up to 60 months
description: Investigators will measure whether the participant was admitted to hospice (Y/N)
measure: Healthcare utilization at end of life - hospice < 3 days
time frame: during bereavement, up to 60 months
description: Investigators will measure whether the participant was admitted to hospice for < 3 days (Y/N)
measure: Healthcare utilization at end of life - hospice length of stay
time frame: during bereavement, up to 60 months
description: For participants admitted to hospice, investigators will measure number of days in hospice.
measure: Healthcare utilization at end of life - hospitalizations
time frame: during bereavement, up to 60 months
description: Investigators will measure number of hospitalizations in the last month of life
measure: Healthcare utilization at end of life - ED visits
time frame: during bereavement, up to 60 months
description: Investigators will measure number of emergency department visits in the last month of life
measure: advance care planning implementation costs
time frame: through study completion, up to 5 years
description: Investigators will assess advance care planning implementation costs by tracking staff time spent on each intervention arm. Staff time costs for each intervention will be estimated by multiplying staff training and patient care time related to the intervention in hours by the average hourly wage for US nursing and social work staff of comparable levels.
arm group label: Facilitated advance care planning (in-person or telephonic)
arm group type: Active Comparator
description: Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.
arm group label: Web-based advance care planning
arm group type: Active Comparator
description: Patients randomized to this arm will participate in web-based ACP via the PREPARE website.
intervention type: Behavioral
intervention name: Facilitated advance care planning (in-person or telephonic)
description: The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences.
arm group label: Facilitated advance care planning (in-person or telephonic)
intervention type: Behavioral
intervention name: Web-based advance care planning
description: Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.
arm group label: Web-based advance care planning
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yael Schenker, MD, MPH
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Yael Schenker, MD, MAS
investigator title: Associate Professor
sharing ipd: No