<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/NCT02243748</url>
  </required_header>
  <id_info>
    <org_study_id>14206</org_study_id>
    <secondary_id>NCI-2014-01926</secondary_id>
    <secondary_id>14206</secondary_id>
    <secondary_id>1R01NR015341-01</secondary_id>
    <nct_id>NCT02243748</nct_id>
  </id_info>
  <brief_title>Palliative Care Intervention in Improving Symptom Control and Quality of Life in Patients With Stage II-IV Non-small Cell Lung Cancer and Their Family Caregivers</brief_title>
  <official_title>Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies a palliative care intervention in improving symptom control and&#xD;
      quality of life in patients with stage II-IV non-small cell lung cancer and their family&#xD;
      caregivers. Palliative care programs can provide patients and their caregivers with&#xD;
      information on how to manage their symptoms, maintain health and well-being, and access&#xD;
      supportive care services. An interdisciplinary palliative care model may effectively link&#xD;
      lung cancer patients to the appropriate supportive care services in a timely fashion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Adapt a Palliative Care Intervention (PCI) tested in a National Cancer Institute (NCI)&#xD;
      funded Program Project (P01) for dissemination to other oncology settings.&#xD;
&#xD;
      II. Determine the impact of the PCI on patient outcomes including symptom control, quality of&#xD;
      life (QOL), and distress as compared to the usual care group.&#xD;
&#xD;
      III. Determine the impact of the PCI on family caregivers (FCG) outcomes including caregiver&#xD;
      burden, caregiver distress, skills preparation and QOL as compared to the usual care group.&#xD;
&#xD;
      IV. Test the effects of the PCI on patient resource utilization as compared to the usual care&#xD;
      group.&#xD;
&#xD;
      OUTLINE: Participants are enrolled sequentially to 1 of 2 phases.&#xD;
&#xD;
      PHASE I: Participants receive usual care. This phase will aid in identifying usual care&#xD;
      patterns in each site and provide an audit of system utilization as well as finalization of&#xD;
      the educational materials for Phase II.&#xD;
&#xD;
      PHASE II: Participants receive individualized palliative care comprised of tailored&#xD;
      educational sessions designed for each patient and FCG that have been modified based on&#xD;
      patterns observed in Phase I. The first patient teaching session will cover physical and&#xD;
      psychological areas and the second will cover social and spiritual areas. These sessions will&#xD;
      be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone&#xD;
      to give the FCG the opportunity to discuss their perspectives and focus on their needs.&#xD;
      Patients will be asked to identify topics they want included and which if any should be&#xD;
      omitted which provides for tailoring of the content to the patient's needs and preferences.&#xD;
&#xD;
      In both groups, participants are followed up for 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">April 22, 2019</completion_date>
  <primary_completion_date type="Actual">April 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of the PCI on symptom control as compared to the usual care group</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The demographic and clinical characteristics as well as baseline symptom control scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of the PCI on patient QOL as compared to the usual care group</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The demographic and clinical characteristics as well as baseline QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of the PCI on psychological distress as compared to the usual care group</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The demographic and clinical characteristics as well as baseline psychological distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of the PCI on caregiver burden as compared to the usual care group</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The demographic and clinical characteristics as well as baseline caregiver burden scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of the PCI on caregiver distress as compared to the usual care group</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The demographic and clinical characteristics as well as baseline caregiver distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of the PCI on caregiver skills preparation as compared to the usual care group</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The demographic and clinical characteristics as well as baseline caregiver skills preparation scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of the PCI on caregiver QOL as compared to the usual care group</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The demographic and clinical characteristics as well as baseline caregiver QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of the PCI on resource utilization as compared to the usual care group</measure>
    <time_frame>Up to 3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">361</enrollment>
  <condition>Caregiver</condition>
  <condition>Psychological Impact of Cancer and Its Treatment</condition>
  <condition>Recurrent Non-small Cell Lung Cancer</condition>
  <condition>Stage IIA Non-small Cell Lung Cancer</condition>
  <condition>Stage IIB Non-small Cell Lung Cancer</condition>
  <condition>Stage IIIA Non-small Cell Lung Cancer</condition>
  <condition>Stage IIIB Non-small Cell Lung Cancer</condition>
  <condition>Stage IV Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Phase I (usual care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive usual care. This phase will aid in identifying usual care patterns in each site and provide an audit of system utilization as well as finalization of the educational materials for Phase II.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase II (individualized palliative care)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive individualized palliative care comprised of tailored educational sessions designed for each patient and FCG that have been modified based on patterns observed in Phase I. The first patient teaching session will cover physical and psychological areas and the second will cover social and spiritual areas. These sessions will be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone to give the FCG the opportunity to discuss their perspectives and focus on their needs. Patients will be asked to identify topics they want included and which if any should be omitted which provides for tailoring of the content to the patient's needs and preferences.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Palliative Therapy</intervention_name>
    <description>Receive individualized palliative care</description>
    <arm_group_label>Phase II (individualized palliative care)</arm_group_label>
    <other_name>Comfort Care</other_name>
    <other_name>Palliative Care</other_name>
    <other_name>Palliative Treatment</other_name>
    <other_name>Symptom Management</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>quality-of-life assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Phase I (usual care)</arm_group_label>
    <arm_group_label>Phase II (individualized palliative care)</arm_group_label>
    <other_name>quality of life assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Phase I (usual care)</arm_group_label>
    <arm_group_label>Phase II (individualized palliative care)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient eligibility criteria for entry into the project include:&#xD;
&#xD;
          -  Diagnosis of stages II-IV non-small cell lung cancer (NSCLC)&#xD;
&#xD;
          -  Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities&#xD;
&#xD;
          -  In Phase 2, subjects are also required on accrual to be referred to Palliative Care&#xD;
&#xD;
        FCG eligibility criteria include:&#xD;
&#xD;
          -  Designated by the patient as a person closely involved in their care&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
        All subjects must have the ability to understand and the willingness to sign a written&#xD;
        informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Betty Ferrell</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huong Nguyen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente Department of Research and Evaluation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Permanente Medical Group</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Ontario Vineyard Medical Offices and Ambulatory SurgiCenter</name>
      <address>
        <city>Ontario</city>
        <state>California</state>
        <zip>91761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Department of Research and Evaluation</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>May 6, 2019</last_update_submitted>
  <last_update_submitted_qc>May 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02243748
org study id: 14206
secondary id: NCI-2014-01926
secondary id: 14206
secondary id: 1R01NR015341-01
nct id: NCT02243748
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This clinical trial studies a palliative care intervention in improving symptom control and
      quality of life in patients with stage II-IV non-small cell lung cancer and their family
      caregivers. Palliative care programs can provide patients and their caregivers with
      information on how to manage their symptoms, maintain health and well-being, and access
      supportive care services. An interdisciplinary palliative care model may effectively link
      lung cancer patients to the appropriate supportive care services in a timely fashion.
PRIMARY OBJECTIVES:

      I. Adapt a Palliative Care Intervention (PCI) tested in a National Cancer Institute (NCI)
      funded Program Project (P01) for dissemination to other oncology settings.

      II. Determine the impact of the PCI on patient outcomes including symptom control, quality of
      life (QOL), and distress as compared to the usual care group.

      III. Determine the impact of the PCI on family caregivers (FCG) outcomes including caregiver
      burden, caregiver distress, skills preparation and QOL as compared to the usual care group.

      IV. Test the effects of the PCI on patient resource utilization as compared to the usual care
      group.

      OUTLINE: Participants are enrolled sequentially to 1 of 2 phases.

      PHASE I: Participants receive usual care. This phase will aid in identifying usual care
      patterns in each site and provide an audit of system utilization as well as finalization of
      the educational materials for Phase II.

      PHASE II: Participants receive individualized palliative care comprised of tailored
      educational sessions designed for each patient and FCG that have been modified based on
      patterns observed in Phase I. The first patient teaching session will cover physical and
      psychological areas and the second will cover social and spiritual areas. These sessions will
      be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone
      to give the FCG the opportunity to discuss their perspectives and focus on their needs.
      Patients will be asked to identify topics they want included and which if any should be
      omitted which provides for tailoring of the content to the patient's needs and preferences.

      In both groups, participants are followed up for 3 months.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Impact of the PCI on symptom control as compared to the usual care group
time frame: Up to 3 months
description: The demographic and clinical characteristics as well as baseline symptom control scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
measure: Impact of the PCI on patient QOL as compared to the usual care group
time frame: Up to 3 months
description: The demographic and clinical characteristics as well as baseline QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
measure: Impact of the PCI on psychological distress as compared to the usual care group
time frame: Up to 3 months
description: The demographic and clinical characteristics as well as baseline psychological distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
measure: Impact of the PCI on caregiver burden as compared to the usual care group
time frame: Up to 3 months
description: The demographic and clinical characteristics as well as baseline caregiver burden scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
measure: Impact of the PCI on caregiver distress as compared to the usual care group
time frame: Up to 3 months
description: The demographic and clinical characteristics as well as baseline caregiver distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
measure: Impact of the PCI on caregiver skills preparation as compared to the usual care group
time frame: Up to 3 months
description: The demographic and clinical characteristics as well as baseline caregiver skills preparation scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
measure: Impact of the PCI on caregiver QOL as compared to the usual care group
time frame: Up to 3 months
description: The demographic and clinical characteristics as well as baseline caregiver QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
measure: Effects of the PCI on resource utilization as compared to the usual care group
time frame: Up to 3 months
arm group label: Phase I (usual care)
arm group type: Active Comparator
description: Participants receive usual care. This phase will aid in identifying usual care patterns in each site and provide an audit of system utilization as well as finalization of the educational materials for Phase II.
arm group label: Phase II (individualized palliative care)
arm group type: Experimental
description: Participants receive individualized palliative care comprised of tailored educational sessions designed for each patient and FCG that have been modified based on patterns observed in Phase I. The first patient teaching session will cover physical and psychological areas and the second will cover social and spiritual areas. These sessions will be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone to give the FCG the opportunity to discuss their perspectives and focus on their needs. Patients will be asked to identify topics they want included and which if any should be omitted which provides for tailoring of the content to the patient's needs and preferences.
intervention type: Other
intervention name: Palliative Therapy
description: Receive individualized palliative care
arm group label: Phase II (individualized palliative care)
other name: Comfort Care
other name: Palliative Care
other name: Palliative Treatment
other name: Symptom Management
intervention type: Other
intervention name: quality-of-life assessment
description: Ancillary studies
arm group label: Phase I (usual care)
arm group label: Phase II (individualized palliative care)
other name: quality of life assessment
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Phase I (usual care)
arm group label: Phase II (individualized palliative care)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Betty Ferrell
role: Principal Investigator
affiliation: City of Hope Medical Center
last name: Huong Nguyen, MD
role: Principal Investigator
affiliation: Kaiser Permanente Department of Research and Evaluation
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung