<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/NCT02966509</url>
  </required_header>
  <id_info>
    <org_study_id>EPAC1</org_study_id>
    <nct_id>NCT02966509</nct_id>
  </id_info>
  <brief_title>Engagement of Patients With Advanced Cancer</brief_title>
  <acronym>EPAC</acronym>
  <official_title>Engagement of Patients With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Palo Alto Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained&#xD;
      lay health coaches to engage patients and their families in goals of care and shared&#xD;
      decision-making after a diagnosis of advanced cancer. Although lay health workers have never&#xD;
      been tested in this role, we hypothesize that lay health workers can feasibly improve goals&#xD;
      of care documentation and help to reduce unwanted healthcare utilization at the end of life&#xD;
      for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      VAPAHCS proposes to implement and evaluate several critical elements to be in alignment with&#xD;
      the VHA's Strategic Goal and priority areas for FY2013. The Engagement of Patients with&#xD;
      Advanced Cancer project is an innovative program that will strengthen provider-patient&#xD;
      relationship and facilitate whole person care about matters important to Veterans with cancer&#xD;
      and important to support network and family. The project is intended to help establish Goals&#xD;
      of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care&#xD;
      for persons with cancer that is intended to improve clinical outcomes and experience of care&#xD;
      for individuals with advanced cancer who have advanced cancer (stages III, IV or recurrent&#xD;
      disease). The intervention provides patients with lay health coaches who assist patients and&#xD;
      their families in discussing goals of care and engage in shared-decision making. The goal of&#xD;
      the project is to demonstrate that there is improved patient experiences, outcomes, and that&#xD;
      the program helps to reduce utilization of health care resources at the end of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 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>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.</measure>
    <time_frame>6 months after each patient enrollment</time_frame>
    <description>Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emergency Department Visit (Chart Review)</measure>
    <time_frame>6 months after patient enrollment</time_frame>
    <description>Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency Department Visit (Chart Review)</measure>
    <time_frame>15 months after patient enrollment</time_frame>
    <description>Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization Visits (Chart Review)</measure>
    <time_frame>6 months after patient enrollment</time_frame>
    <description>Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization Visits (Chart Review)</measure>
    <time_frame>15 months after patient enrollment</time_frame>
    <description>Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospice Referral (Chart Review)</measure>
    <time_frame>6 months after patient enrollment</time_frame>
    <description>Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palliative Care Referral (Chart Review)</measure>
    <time_frame>6 months after patient enrollment</time_frame>
    <description>Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palliative Care Referral (Chart Review)</measure>
    <time_frame>15 months after patient enrollment</time_frame>
    <description>Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey</measure>
    <time_frame>Change in Patient Satisfaction with Care from baseline to 6 months.</time_frame>
    <description>Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey</measure>
    <time_frame>6 months</time_frame>
    <description>Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>End of Life</condition>
  <condition>Advanced Cancer</condition>
  <condition>Lung Neoplasm</condition>
  <condition>Gastric Cancer</condition>
  <condition>Colon Cancer</condition>
  <condition>Glioblastoma Multiforme</condition>
  <condition>Head and Neck Neoplasms</condition>
  <condition>Rectum Cancer</condition>
  <condition>Melanoma</condition>
  <condition>Kidney Cancer</condition>
  <condition>Prostate Cancer</condition>
  <condition>Testicular Neoplasms</condition>
  <condition>Liver Cancer</condition>
  <condition>Cancer of Unknown Origin</condition>
  <arm_group>
    <arm_group_label>A: Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B: Control Group Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All participants randomized to Arm B will receive usual oncologic care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EPAC</intervention_name>
    <description>Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
    <arm_group_label>A: Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed stage III or IV cancer&#xD;
&#xD;
          -  Recurrent disease (any stage)&#xD;
&#xD;
          -  Ability to consent to study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are unable to consent to study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <results_first_submitted>January 4, 2017</results_first_submitted>
  <results_first_submitted_qc>May 12, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 18, 2017</results_first_posted>
  <last_update_submitted>October 4, 2018</last_update_submitted>
  <last_update_submitted_qc>October 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Manali Indravadan Patel</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Kidney Neoplasms</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Testicular Neoplasms</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>August 2013 recruitment for overall study through new patient visit screening, phone calls to patients prior to first oncology appointment, and referral by physicians when diagnosed with recurrent cancers. Recruitment completed in February 2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>A: Intervention Arm</title>
          <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
        </group>
        <group group_id="P2">
          <title>B: Control Group Arm</title>
          <description>All participants randomized to Arm B will receive usual oncologic care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline Satisfaction Survey</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused to Answer</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6 Month Satisfaction Decision Survey</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused to Answer</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6 Month Satisfaction Survey</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused to Answer</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6-Month Utilization and Cost</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>15-Month Utilization and Cost</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>End of Life Utilization and Cost 6 Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Patient Still Alive</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>End of Life Utilization and Cost 15month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Patient Still Alive</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>A: Intervention Arm</title>
          <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
        </group>
        <group group_id="B2">
          <title>B: Control Group Arm</title>
          <description>All participants randomized to Arm B will receive usual oncologic care.</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="105"/>
            <count group_id="B2" value="108"/>
            <count group_id="B3" value="213"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="69.2" spread="9.20"/>
                    <measurement group_id="B2" value="69.4" spread="9.05"/>
                    <measurement group_id="B3" value="69.3" spread="9.10"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="211"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="165"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>Country</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Thoracic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gastrointestinal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genitourinary</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Head and Neck</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Skin</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer Stage at Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unmarried</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Baseline Health Care Costs</title>
          <units>US Dollars</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14052" lower_limit="4613" upper_limit="35684"/>
                    <measurement group_id="B2" value="11455" lower_limit="3567" upper_limit="29085"/>
                    <measurement group_id="B3" value="13090" lower_limit="4091" upper_limit="29729"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.</title>
        <description>Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.</description>
        <time_frame>6 months after each patient enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A: Intervention Arm</title>
            <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
          </group>
          <group group_id="O2">
            <title>B: Control Group Arm</title>
            <description>All participants randomized to Arm B will receive usual oncologic care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.</title>
          <description>Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Emergency Department Visit (Chart Review)</title>
        <description>Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
        <time_frame>6 months after patient enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A: Intervention Arm</title>
            <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
          </group>
          <group group_id="O2">
            <title>B: Control Group Arm</title>
            <description>All participants randomized to Arm B will receive usual oncologic care.</description>
          </group>
        </group_list>
        <measure>
          <title>Emergency Department Visit (Chart Review)</title>
          <description>Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
          <units>visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74" spread="1.12"/>
                    <measurement group_id="O2" value="0.78" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Emergency Department Visit (Chart Review)</title>
        <description>Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.</description>
        <time_frame>15 months after patient enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A: Intervention Arm</title>
            <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
          </group>
          <group group_id="O2">
            <title>B: Control Group Arm</title>
            <description>All participants randomized to Arm B will receive usual oncologic care.</description>
          </group>
        </group_list>
        <measure>
          <title>Emergency Department Visit (Chart Review)</title>
          <description>Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.</description>
          <units>Visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="1.40"/>
                    <measurement group_id="O2" value="1.20" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospitalization Visits (Chart Review)</title>
        <description>Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
        <time_frame>6 months after patient enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A: Intervention Arm</title>
            <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
          </group>
          <group group_id="O2">
            <title>B: Control Group Arm</title>
            <description>All participants randomized to Arm B will receive usual oncologic care.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalization Visits (Chart Review)</title>
          <description>Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
          <units>Visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62" spread="0.80"/>
                    <measurement group_id="O2" value="0.56" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospitalization Visits (Chart Review)</title>
        <description>Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.</description>
        <time_frame>15 months after patient enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A: Intervention Arm</title>
            <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
          </group>
          <group group_id="O2">
            <title>B: Control Group Arm</title>
            <description>All participants randomized to Arm B will receive usual oncologic care.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalization Visits (Chart Review)</title>
          <description>Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.</description>
          <units>Visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="0.94"/>
                    <measurement group_id="O2" value="0.88" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospice Referral (Chart Review)</title>
        <description>Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
        <time_frame>6 months after patient enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A: Intervention Arm</title>
            <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
          </group>
          <group group_id="O2">
            <title>B: Control Group Arm</title>
            <description>All participants randomized to Arm B will receive usual oncologic care.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospice Referral (Chart Review)</title>
          <description>Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Palliative Care Referral (Chart Review)</title>
        <description>Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
        <time_frame>6 months after patient enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A: Intervention Arm</title>
            <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
          </group>
          <group group_id="O2">
            <title>B: Control Group Arm</title>
            <description>All participants randomized to Arm B will receive usual oncologic care.</description>
          </group>
        </group_list>
        <measure>
          <title>Palliative Care Referral (Chart Review)</title>
          <description>Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Palliative Care Referral (Chart Review)</title>
        <description>Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.</description>
        <time_frame>15 months after patient enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A: Intervention Arm</title>
            <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
          </group>
          <group group_id="O2">
            <title>B: Control Group Arm</title>
            <description>All participants randomized to Arm B will receive usual oncologic care.</description>
          </group>
        </group_list>
        <measure>
          <title>Palliative Care Referral (Chart Review)</title>
          <description>Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey</title>
        <description>Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.</description>
        <time_frame>Change in Patient Satisfaction with Care from baseline to 6 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A: Intervention Arm</title>
            <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
          </group>
          <group group_id="O2">
            <title>B: Control Group Arm</title>
            <description>All participants randomized to Arm B will receive usual oncologic care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey</title>
          <description>Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.54" spread="2.40"/>
                    <measurement group_id="O2" value="-0.99" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey</title>
        <description>Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A: Intervention Arm</title>
            <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
          </group>
          <group group_id="O2">
            <title>B: Control Group Arm</title>
            <description>All participants randomized to Arm B will receive usual oncologic care.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey</title>
          <description>Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.73" spread="0.61"/>
                    <measurement group_id="O2" value="4.15" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Time frame for adverse event reporting was at 3, 6, 12, and 15 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>A: Intervention Arm</title>
          <description>All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.&#xD;
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.</description>
        </group>
        <group group_id="E2">
          <title>B: Control Group Arm</title>
          <description>All participants randomized to Arm B will receive usual oncologic care.</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="105"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="108"/>
              </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="105"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="108"/>
              </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>Dr. Manali Patel</name_or_title>
      <organization>Stanford University and VA Palo Alto Health Care System</organization>
      <phone>650-723-4000</phone>
      <email>manalip@stanford.edu</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/NCT02966509
org study id: EPAC1
nct id: NCT02966509
lead sponsor: 
collaborator: 
has dmc: No
The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained
      lay health coaches to engage patients and their families in goals of care and shared
      decision-making after a diagnosis of advanced cancer. Although lay health workers have never
      been tested in this role, we hypothesize that lay health workers can feasibly improve goals
      of care documentation and help to reduce unwanted healthcare utilization at the end of life
      for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent
      disease.
VAPAHCS proposes to implement and evaluate several critical elements to be in alignment with
      the VHA's Strategic Goal and priority areas for FY2013. The Engagement of Patients with
      Advanced Cancer project is an innovative program that will strengthen provider-patient
      relationship and facilitate whole person care about matters important to Veterans with cancer
      and important to support network and family. The project is intended to help establish Goals
      of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care
      for persons with cancer that is intended to improve clinical outcomes and experience of care
      for individuals with advanced cancer who have advanced cancer (stages III, IV or recurrent
      disease). The intervention provides patients with lay health coaches who assist patients and
      their families in discussing goals of care and engage in shared-decision making. The goal of
      the project is to demonstrate that there is improved patient experiences, outcomes, and that
      the program helps to reduce utilization of health care resources at the end of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.
time frame: 6 months after each patient enrollment
description: Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.
measure: Emergency Department Visit (Chart Review)
time frame: 6 months after patient enrollment
description: Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
measure: Emergency Department Visit (Chart Review)
time frame: 15 months after patient enrollment
description: Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
measure: Hospitalization Visits (Chart Review)
time frame: 6 months after patient enrollment
description: Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
measure: Hospitalization Visits (Chart Review)
time frame: 15 months after patient enrollment
description: Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
measure: Hospice Referral (Chart Review)
time frame: 6 months after patient enrollment
description: Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
measure: Palliative Care Referral (Chart Review)
time frame: 6 months after patient enrollment
description: Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
measure: Palliative Care Referral (Chart Review)
time frame: 15 months after patient enrollment
description: Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
measure: Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
time frame: Change in Patient Satisfaction with Care from baseline to 6 months.
description: Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.
measure: Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
time frame: 6 months
description: Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.
arm group label: A: Intervention Arm
arm group type: Experimental
description: All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.
arm group label: B: Control Group Arm
arm group type: No Intervention
description: All participants randomized to Arm B will receive usual oncologic care.
intervention type: Behavioral
intervention name: EPAC
description: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
arm group label: A: Intervention Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Manali Indravadan Patel
investigator title: Assistant Professor
mesh term: Neoplasms
mesh term: Glioblastoma
mesh term: Kidney Neoplasms
mesh term: Lung Neoplasms
mesh term: Head and Neck Neoplasms
mesh term: Rectal Neoplasms
mesh term: Testicular Neoplasms
mesh term: Death
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 