<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/NCT03007953</url>
  </required_header>
  <id_info>
    <org_study_id>NRI 15-456</org_study_id>
    <nct_id>NCT03007953</nct_id>
  </id_info>
  <brief_title>Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II</brief_title>
  <acronym>PCI2</acronym>
  <official_title>Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The focus of the study is to test a nurse-led telephone-based palliative care intervention on&#xD;
      improving the delivery of care for patients with newly diagnosed lung cancer. The study is a&#xD;
      three site randomized control trial to determine the efficacy of the intervention on&#xD;
      improving patients' quality of life, symptom burden, and satisfaction of care. Additionally,&#xD;
      the study will test an innovative care delivery model to improve patients' access to&#xD;
      palliative care. The investigators will also determine the effect of the intervention on&#xD;
      patient activation to discuss treatment preferences with their clinician and on clinician&#xD;
      knowledge of patients' goals of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients meeting entry criteria will be randomized to the intervention arm, palliative care&#xD;
      plus usual care, or the usual care arm. Patients randomized to the intervention arm will&#xD;
      receive usual oncologic care and phone calls from a nurse. Outcome measures will be collected&#xD;
      at baseline and at the end of the patients' primary cancer treatment. The study will be&#xD;
      performed at the Puget Sound Health Care System, Birmingham VA and Portland VA. The&#xD;
      investigators will recruit individuals (n=138) with lung cancer over 2.5 years. The primary&#xD;
      objective is to determine the efficacy of the nurse-led telephone-based palliative&#xD;
      intervention on improving patients' quality of life, symptom burden, and satisfaction of&#xD;
      care. In addition, using validated instruments, the investigators will assess the effect of&#xD;
      the intervention on patient activation to discuss treatment preferences with their clinician&#xD;
      and on clinician knowledge of patients' goals of care. The results of this study will inform&#xD;
      a future effectiveness/implementation study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">December 11, 2019</completion_date>
  <primary_completion_date type="Actual">December 11, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit</measure>
    <time_frame>Baseline and 3 Months</time_frame>
    <description>Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84, with a higher score indicating a better quality of life. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FACT-L TOI score. The investigators will assess the difference in FACT-L TOI scores between the intervention and control subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Satisfaction of Care at Final Visit</measure>
    <time_frame>Baseline and 3 Months</time_frame>
    <description>Patient satisfaction with care will be assessed by using the FAMCARE-Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total score are reported (no subscales). Scores range from 13-65 with scores of 52 &gt; being satisfied with care. In full randomized clinical trials the estimated MID is 5 points from baseline to 12 weeks. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FAMCARE-P13 score. The investigators will assess the difference in FAMCARE-P13 scores between the intervention and control subjects.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Palliative Care</intervention_name>
    <description>Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Supportive Care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients diagnosed at the Puget Sound Health Care System, Birmingham VA, or Portland VA&#xD;
        with a primary diagnosis of lung cancer that requires more than surgical resection:&#xD;
&#xD;
          -  diagnosed within 8 weeks of recruitment&#xD;
&#xD;
          -  must have telephone access&#xD;
&#xD;
          -  ability to understand English&#xD;
&#xD;
          -  able to participate in informed consent process&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients not eligible to participate in the study include those who are inpatients prior to&#xD;
        randomization,&#xD;
&#xD;
          -  those who are under the care of palliative care or hospice at the time of&#xD;
             randomization&#xD;
&#xD;
          -  those who have severe mental health disorders&#xD;
&#xD;
          -  those who are unable to speak directly with the nurse over the telephone&#xD;
&#xD;
          -  or those that have the inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynn F. Reinke, PhD ARNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Puget Sound Health Care System Seattle Division, Seattle, WA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Birmingham VA Medical Center, Birmingham, AL</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233-1927</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Portland Health Care System, Portland, OR</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System Seattle Division, Seattle, WA</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108-1532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Reinke LF, Meier DE. Research Priorities in Subspecialty Palliative Care: Policy Initiatives. J Palliat Med. 2017 Aug;20(8):813-820. doi: 10.1089/jpm.2017.0303.</citation>
    <PMID>28777716</PMID>
  </results_reference>
  <results_reference>
    <citation>Aslakson RA, Reinke LF, Cox C, Kross EK, Benzo RP, Curtis JR. Developing a Research Agenda for Integrating Palliative Care into Critical Care and Pulmonary Practice To Improve Patient and Family Outcomes. J Palliat Med. 2017 Apr;20(4):329-343. doi: 10.1089/jpm.2016.0567.</citation>
    <PMID>28379812</PMID>
  </results_reference>
  <results_reference>
    <citation>Reinke LF, Vig EK, Tartaglione EV, Backhus LM, Gunnink E, Au DH. Protocol and pilot testing: The feasibility and acceptability of a nurse-led telephone-based palliative care intervention for patients newly diagnosed with lung cancer. Contemp Clin Trials. 2018 Jan;64:30-34. doi: 10.1016/j.cct.2017.11.013. Epub 2017 Nov 23. No abstract available.</citation>
    <PMID>29175560</PMID>
  </results_reference>
  <results_reference>
    <citation>Sullivan DR, Chan B, Lapidus JA, Ganzini L, Hansen L, Carney PA, Fromme EK, Marino M, Golden SE, Vranas KC, Slatore CG. Association of Early Palliative Care Use With Survival and Place of Death Among Patients With Advanced Lung Cancer Receiving Care in the Veterans Health Administration. JAMA Oncol. 2019 Dec 1;5(12):1702-1709. doi: 10.1001/jamaoncol.2019.3105.</citation>
    <PMID>31536133</PMID>
  </results_reference>
  <results_reference>
    <citation>Sullivan DR, Ganzini L, Delorit MA, Slatore CG, Vranas KC, Golden SE, Hansen L. Transcending silos and building relationships: A qualitative study of palliative care use and integration in a national health system. [Abstract]. American journal of respiratory and critical care medicine. 2020 Nov 1; 201(B22):A2820.</citation>
  </results_reference>
  <results_reference>
    <citation>Sullivan DR, Slatore CG, Stone K, Nugent S, Kern J, Farris M, Roszenweig K, Swanson S, J Wisnivesky JP. Associations between Treatment and Team Composition with Decisional Regret among Patients with Early Stage Lung Cancer. [Abstract]. American journal of respiratory and critical care medicine. 2020 Nov 1; 201(B22):A4726.</citation>
  </results_reference>
  <results_reference>
    <citation>Vranas KC, Plinke W, Bourne D, Kansagara D, Lee RY, Kross EK, Slatore CG, Sullivan DR. The influence of POLST on treatment intensity at the end of life: A systematic review. J Am Geriatr Soc. 2021 Dec;69(12):3661-3674. doi: 10.1111/jgs.17447. Epub 2021 Sep 22.</citation>
    <PMID>34549418</PMID>
  </results_reference>
  <results_reference>
    <citation>Hedstrom GH, Hooker ER, Howard M, Shull S, Golden SE, Deffebach ME, Gorman JD, Murphy K, Fabbrini A, Melzer AC, Slatore CG. The Chain of Adherence for Incidentally Detected Pulmonary Nodules after an Initial Radiologic Imaging Study: A Multisystem Observational Study. Ann Am Thorac Soc. 2022 Aug;19(8):1379-1389. doi: 10.1513/AnnalsATS.202111-1220OC.</citation>
    <PMID>35167780</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>June 7, 2021</results_first_submitted>
  <results_first_submitted_qc>September 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 7, 2021</results_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Palliative Care</keyword>
  <keyword>Supportive Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03007953/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>We identified lung cancer patients at the Puget Sound Health Care System, the Birmingham VA, and the Portland VA. Virtually all patients undergoing evaluation for lung cancer were presented at the Tumor Board and/or were evaluated in the chest (thoracic surgery and pulmonary), oncology, radiation oncology, or lung cancer clinics. All patients were screened weekly to determine study eligibility. Recruitment began when the first patient enrolled on December 2016 and lasted to June 2019.</recruitment_details>
      <pre_assignment_details>If consented participants became ineligible, they were not randomized into one of the two study arms.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).&#xD;
Palliative Care: Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrolled in Hospice</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).&#xD;
Palliative Care: Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.</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="73"/>
            <count group_id="B2" value="78"/>
            <count group_id="B3" value="151"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Mean, SD</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.0" spread="8.6"/>
                    <measurement group_id="B2" value="70.0" spread="6.4"/>
                    <measurement group_id="B3" value="69.5" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="148"/>
                  </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="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit</title>
        <description>Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84, with a higher score indicating a better quality of life. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FACT-L TOI score. The investigators will assess the difference in FACT-L TOI scores between the intervention and control subjects.</description>
        <time_frame>Baseline and 3 Months</time_frame>
        <population>Difference in FACT-L TOI score, Final Visit Measure, minus Baseline Visit Measure</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).&#xD;
Palliative Care: Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit</title>
          <description>Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84, with a higher score indicating a better quality of life. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FACT-L TOI score. The investigators will assess the difference in FACT-L TOI scores between the intervention and control subjects.</description>
          <population>Difference in FACT-L TOI score, Final Visit Measure, minus Baseline Visit Measure</population>
          <units>score 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="73"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="16.8"/>
                    <measurement group_id="O2" value="-1.2" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Satisfaction of Care at Final Visit</title>
        <description>Patient satisfaction with care will be assessed by using the FAMCARE-Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total score are reported (no subscales). Scores range from 13-65 with scores of 52 &gt; being satisfied with care. In full randomized clinical trials the estimated MID is 5 points from baseline to 12 weeks. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FAMCARE-P13 score. The investigators will assess the difference in FAMCARE-P13 scores between the intervention and control subjects.</description>
        <time_frame>Baseline and 3 Months</time_frame>
        <population>Difference in FAMCARE-13 Score, Final Visit measure minus Baseline Visit Measure</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).&#xD;
Palliative Care: Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Satisfaction of Care at Final Visit</title>
          <description>Patient satisfaction with care will be assessed by using the FAMCARE-Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total score are reported (no subscales). Scores range from 13-65 with scores of 52 &gt; being satisfied with care. In full randomized clinical trials the estimated MID is 5 points from baseline to 12 weeks. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FAMCARE-P13 score. The investigators will assess the difference in FAMCARE-P13 scores between the intervention and control subjects.</description>
          <population>Difference in FAMCARE-13 Score, Final Visit measure minus Baseline Visit Measure</population>
          <units>score 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="73"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="7.6"/>
                    <measurement group_id="O2" value="0.5" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Each participant was assessed for adverse events through the study completion, e.g. 3 months or at the end of cancer treatment.</time_frame>
      <desc>ER visits, hospitalizations, and death are expected for patients with advanced cancers. All ER/Hospitalizations/Deaths were collected during medical record review and patients self-report (intervention arm only). They were reviewed at weekly study meetings and annually by the IRBs for each study site. Organ systems were not collected. N/A</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).&#xD;
Palliative Care: Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Serious adverse events</sub_title>
                <description>Hospitalization</description>
                <counts group_id="E1" events="29" subjects_affected="19" subjects_at_risk="73"/>
                <counts group_id="E2" events="14" subjects_affected="11" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Emergency Department Visits</sub_title>
                <counts group_id="E1" events="35" subjects_affected="22" subjects_at_risk="73"/>
                <counts group_id="E2" events="17" subjects_affected="13" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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. Lynn F. Reinke</name_or_title>
      <organization>Department of Veterans Affairs</organization>
      <phone>206-277-4186</phone>
      <email>Lynn.Reinke1@va.gov</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/NCT03007953
org study id: NRI 15-456
nct id: NCT03007953
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The focus of the study is to test a nurse-led telephone-based palliative care intervention on
      improving the delivery of care for patients with newly diagnosed lung cancer. The study is a
      three site randomized control trial to determine the efficacy of the intervention on
      improving patients' quality of life, symptom burden, and satisfaction of care. Additionally,
      the study will test an innovative care delivery model to improve patients' access to
      palliative care. The investigators will also determine the effect of the intervention on
      patient activation to discuss treatment preferences with their clinician and on clinician
      knowledge of patients' goals of care.
Patients meeting entry criteria will be randomized to the intervention arm, palliative care
      plus usual care, or the usual care arm. Patients randomized to the intervention arm will
      receive usual oncologic care and phone calls from a nurse. Outcome measures will be collected
      at baseline and at the end of the patients' primary cancer treatment. The study will be
      performed at the Puget Sound Health Care System, Birmingham VA and Portland VA. The
      investigators will recruit individuals (n=138) with lung cancer over 2.5 years. The primary
      objective is to determine the efficacy of the nurse-led telephone-based palliative
      intervention on improving patients' quality of life, symptom burden, and satisfaction of
      care. In addition, using validated instruments, the investigators will assess the effect of
      the intervention on patient activation to discuss treatment preferences with their clinician
      and on clinician knowledge of patients' goals of care. The results of this study will inform
      a future effectiveness/implementation study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit
time frame: Baseline and 3 Months
description: Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84, with a higher score indicating a better quality of life. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FACT-L TOI score. The investigators will assess the difference in FACT-L TOI scores between the intervention and control subjects.
measure: Change From Baseline in Patient Satisfaction of Care at Final Visit
time frame: Baseline and 3 Months
description: Patient satisfaction with care will be assessed by using the FAMCARE-Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total score are reported (no subscales). Scores range from 13-65 with scores of 52 > being satisfied with care. In full randomized clinical trials the estimated MID is 5 points from baseline to 12 weeks. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FAMCARE-P13 score. The investigators will assess the difference in FAMCARE-P13 scores between the intervention and control subjects.
arm group label: Intervention
arm group type: Experimental
description: This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).
arm group label: Usual Care
arm group type: No Intervention
description: Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
intervention type: Behavioral
intervention name: Palliative Care
description: Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.
arm group label: Intervention
other name: Supportive Care
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Lynn F. Reinke, PhD ARNP
role: Principal Investigator
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
facility: 
facility: 
facility: 
country: United States
citation: Reinke LF, Meier DE. Research Priorities in Subspecialty Palliative Care: Policy Initiatives. J Palliat Med. 2017 Aug;20(8):813-820. doi: 10.1089/jpm.2017.0303.
PMID: 28777716
citation: Aslakson RA, Reinke LF, Cox C, Kross EK, Benzo RP, Curtis JR. Developing a Research Agenda for Integrating Palliative Care into Critical Care and Pulmonary Practice To Improve Patient and Family Outcomes. J Palliat Med. 2017 Apr;20(4):329-343. doi: 10.1089/jpm.2016.0567.
PMID: 28379812
citation: Reinke LF, Vig EK, Tartaglione EV, Backhus LM, Gunnink E, Au DH. Protocol and pilot testing: The feasibility and acceptability of a nurse-led telephone-based palliative care intervention for patients newly diagnosed with lung cancer. Contemp Clin Trials. 2018 Jan;64:30-34. doi: 10.1016/j.cct.2017.11.013. Epub 2017 Nov 23. No abstract available.
PMID: 29175560
citation: Sullivan DR, Chan B, Lapidus JA, Ganzini L, Hansen L, Carney PA, Fromme EK, Marino M, Golden SE, Vranas KC, Slatore CG. Association of Early Palliative Care Use With Survival and Place of Death Among Patients With Advanced Lung Cancer Receiving Care in the Veterans Health Administration. JAMA Oncol. 2019 Dec 1;5(12):1702-1709. doi: 10.1001/jamaoncol.2019.3105.
PMID: 31536133
citation: Sullivan DR, Ganzini L, Delorit MA, Slatore CG, Vranas KC, Golden SE, Hansen L. Transcending silos and building relationships: A qualitative study of palliative care use and integration in a national health system. [Abstract]. American journal of respiratory and critical care medicine. 2020 Nov 1; 201(B22):A2820.
citation: Sullivan DR, Slatore CG, Stone K, Nugent S, Kern J, Farris M, Roszenweig K, Swanson S, J Wisnivesky JP. Associations between Treatment and Team Composition with Decisional Regret among Patients with Early Stage Lung Cancer. [Abstract]. American journal of respiratory and critical care medicine. 2020 Nov 1; 201(B22):A4726.
citation: Vranas KC, Plinke W, Bourne D, Kansagara D, Lee RY, Kross EK, Slatore CG, Sullivan DR. The influence of POLST on treatment intensity at the end of life: A systematic review. J Am Geriatr Soc. 2021 Dec;69(12):3661-3674. doi: 10.1111/jgs.17447. Epub 2021 Sep 22.
PMID: 34549418
citation: Hedstrom GH, Hooker ER, Howard M, Shull S, Golden SE, Deffebach ME, Gorman JD, Murphy K, Fabbrini A, Melzer AC, Slatore CG. The Chain of Adherence for Incidentally Detected Pulmonary Nodules after an Initial Radiologic Imaging Study: A Multisystem Observational Study. Ann Am Thorac Soc. 2022 Aug;19(8):1379-1389. doi: 10.1513/AnnalsATS.202111-1220OC.
PMID: 35167780
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 