<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/NCT01695382</url>
  </required_header>
  <id_info>
    <org_study_id>12-0592</org_study_id>
    <nct_id>NCT01695382</nct_id>
  </id_info>
  <brief_title>Apoyo Con Carino: Patient Navigation for Palliative Care</brief_title>
  <official_title>Apoyo Con Carino: Patient Navigation to Improve Palliative Care Outcomes for Latinos With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Palliative care is a priority area of focus for health care in an aging population&#xD;
      experiencing burdens of chronic illness. Despite the evidence-based benefits of palliative&#xD;
      care, access remains limited, especially in poor urban and rural settings. Cultural and&#xD;
      linguistic barriers may also increase disparities in palliative care for Latinos. Due to a&#xD;
      nationwide shortage of palliative care providers and the unique cultural preferences and&#xD;
      values of patients, the investigators are testing a patient navigator intervention to improve&#xD;
      palliative care outcomes for Latinos with advanced cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project uses a patient navigator to deliver a culturally tailored intervention to&#xD;
      improve palliative care for Latinos with advanced cancer in urban and rural communities. The&#xD;
      proposed research aims to improve palliative care with the goal of preventing and relieving&#xD;
      suffering for people facing serious, complex illness. Palliative care, according to the&#xD;
      National Quality Forum and Centers for Medicare and Medicaid, provides patient and&#xD;
      family-centered care offered in conjunction with curative and all other appropriate forms of&#xD;
      medical treatment. It addresses physical, intellectual, emotional, social, spiritual needs,&#xD;
      and facilitates patients' understanding of illness and choice. There is emerging evidence&#xD;
      that palliative care may also improve survival for cancer patients. The proposed research&#xD;
      also focuses on reducing health disparities. Studies have shown that Latinos are more likely&#xD;
      to die in a hospital, less likely to use hospice services, and more likely to have unmanaged&#xD;
      pain. This study will recruit 240 Latino patients with advanced cancer from an urban safety&#xD;
      net hospital, a National Cancer Institute-designated Comprehensive Cancer Center, and several&#xD;
      rural communities (including some of the poorest, most underserved counties in Colorado).&#xD;
      Patients will be randomized to either a control or intervention group. The control group will&#xD;
      receive written materials covering three important palliative care domains -advance care&#xD;
      planning, pain management, and hospice care. The materials, in English and Spanish, are&#xD;
      appropriate for patients with low health literacy. Patients in the intervention group will&#xD;
      receive the same written materials but will also have a patient navigator who will make 5&#xD;
      home visits to review materials, help patients and families talk about goals/values, and&#xD;
      complete an advance directive, all in a culturally and linguistically appropriate manner. The&#xD;
      navigator may also help with: accessing community resources, participating in family meetings&#xD;
      with health care providers, and offering support to patients and families. The investigators&#xD;
      hypothesize that the intervention will increase advance care planning, improve pain&#xD;
      management, increase hospice referrals, and patients will have improved palliative care&#xD;
      overall at the end of life. The patient navigator model has demonstrated an ability to&#xD;
      improve cancer screening, early diagnosis, treatment, and survivorship. Once the&#xD;
      investigators demonstrate the efficacy of a patient navigator intervention to improve&#xD;
      palliative care for advanced cancer patients, they can disseminate the training and&#xD;
      intervention to all patient navigators working with Latino cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Palliative Care Overall</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>Patient Navigator and Process Measure will capture the less tangible benefits of a patient navigator and help understand the effects of the many activities of the navigator beyond the scope of the prescribed intervention. The questions incorporate aspects of self-efficacy and patient activation (key concepts that patient navigators help improve).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evidence of Advance Care Planning</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>Chart review to determine if there is an advance directive in the medical record and classification of the type of advance directive (Medical Durable Power of Attorney (MDPOA), Advance Directive (AD), Living Will)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assesment of Pain Management</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>Pain management will be assessed through patient interviews utilizing the Brief Pain Inventory (BPI). The BPI Long Form (BPI-LF) is a 32-item self-report instrument that assesses the severity and impact of pain in patients with chronic diseases, e.g. cancer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospice Utilization</measure>
    <time_frame>46 months after enrollment</time_frame>
    <description>Length of stay in hospice program in days. Data will be collected through follow up phone calls, medical records review, and death records review to determine date of admission into hospice program and date of discharge (through death or dis-enrollment)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aggressiveness of Care at the End of Life</measure>
    <time_frame>At month 46</time_frame>
    <description>For patients who have died within the follow up period this outcome assesses aggressiveness of care at the end of life using a composite measure comprised of the following: chemotherapy within 14 days of death no hospice hospice within 3 days of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Baseline and 3 months after enrollment</time_frame>
    <description>McGill Quality of Life questionnaire (MQOL) will be used at baseline and at 3 months after enrollment. The MQOL is specifically designed for a palliative care population, measuring whole-person concerns magnified by advanced life-limiting illness. It is short, reliable, repeatable, and can be used to determine changes in QOL of groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">223</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the control arm of the study will receive a packet of written materials that are appropriate linguistically and written for individuals with low health literacy. In addition they will have 5 navigator initiated home visits to review the educational materials and help patients and families address barriers to palliative care through education, advocacy, and activation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the control arm of the study will receive a packet of written materials that are appropriate linguistically and written for individuals with low health literacy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Navigation</intervention_name>
    <description>As per Arm description</description>
    <arm_group_label>Navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage III or Stage IV cancer (all types)&#xD;
&#xD;
          -  Self-identify as Latino&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Speak English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lacking decisional capacity&#xD;
&#xD;
          -  Incarcerated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stacy M Fischer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Luis Valley Regional Medical Center</name>
      <address>
        <city>Alamosa</city>
        <state>Colorado</state>
        <zip>81101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Health and Hospital Authority</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaw Cancer Center</name>
      <address>
        <city>Eagle</city>
        <state>Colorado</state>
        <zip>81632</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley View Medical Center</name>
      <address>
        <city>Glenwood Springs</city>
        <state>Colorado</state>
        <zip>81601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Palliative Care</keyword>
  <keyword>Patient Navigation</keyword>
  <!-- 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/NCT01695382
org study id: 12-0592
nct id: NCT01695382
lead sponsor: 
collaborator: 
has dmc: No
Palliative care is a priority area of focus for health care in an aging population
      experiencing burdens of chronic illness. Despite the evidence-based benefits of palliative
      care, access remains limited, especially in poor urban and rural settings. Cultural and
      linguistic barriers may also increase disparities in palliative care for Latinos. Due to a
      nationwide shortage of palliative care providers and the unique cultural preferences and
      values of patients, the investigators are testing a patient navigator intervention to improve
      palliative care outcomes for Latinos with advanced cancer.
This project uses a patient navigator to deliver a culturally tailored intervention to
      improve palliative care for Latinos with advanced cancer in urban and rural communities. The
      proposed research aims to improve palliative care with the goal of preventing and relieving
      suffering for people facing serious, complex illness. Palliative care, according to the
      National Quality Forum and Centers for Medicare and Medicaid, provides patient and
      family-centered care offered in conjunction with curative and all other appropriate forms of
      medical treatment. It addresses physical, intellectual, emotional, social, spiritual needs,
      and facilitates patients' understanding of illness and choice. There is emerging evidence
      that palliative care may also improve survival for cancer patients. The proposed research
      also focuses on reducing health disparities. Studies have shown that Latinos are more likely
      to die in a hospital, less likely to use hospice services, and more likely to have unmanaged
      pain. This study will recruit 240 Latino patients with advanced cancer from an urban safety
      net hospital, a National Cancer Institute-designated Comprehensive Cancer Center, and several
      rural communities (including some of the poorest, most underserved counties in Colorado).
      Patients will be randomized to either a control or intervention group. The control group will
      receive written materials covering three important palliative care domains -advance care
      planning, pain management, and hospice care. The materials, in English and Spanish, are
      appropriate for patients with low health literacy. Patients in the intervention group will
      receive the same written materials but will also have a patient navigator who will make 5
      home visits to review materials, help patients and families talk about goals/values, and
      complete an advance directive, all in a culturally and linguistically appropriate manner. The
      navigator may also help with: accessing community resources, participating in family meetings
      with health care providers, and offering support to patients and families. The investigators
      hypothesize that the intervention will increase advance care planning, improve pain
      management, increase hospice referrals, and patients will have improved palliative care
      overall at the end of life. The patient navigator model has demonstrated an ability to
      improve cancer screening, early diagnosis, treatment, and survivorship. Once the
      investigators demonstrate the efficacy of a patient navigator intervention to improve
      palliative care for advanced cancer patients, they can disseminate the training and
      intervention to all patient navigators working with Latino cancer patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Improvement in Palliative Care Overall
time frame: 3 months after enrollment
description: Patient Navigator and Process Measure will capture the less tangible benefits of a patient navigator and help understand the effects of the many activities of the navigator beyond the scope of the prescribed intervention. The questions incorporate aspects of self-efficacy and patient activation (key concepts that patient navigators help improve).
measure: Evidence of Advance Care Planning
time frame: 6 months after enrollment
description: Chart review to determine if there is an advance directive in the medical record and classification of the type of advance directive (Medical Durable Power of Attorney (MDPOA), Advance Directive (AD), Living Will)
measure: Assesment of Pain Management
time frame: 3 months after enrollment
description: Pain management will be assessed through patient interviews utilizing the Brief Pain Inventory (BPI). The BPI Long Form (BPI-LF) is a 32-item self-report instrument that assesses the severity and impact of pain in patients with chronic diseases, e.g. cancer.
measure: Hospice Utilization
time frame: 46 months after enrollment
description: Length of stay in hospice program in days. Data will be collected through follow up phone calls, medical records review, and death records review to determine date of admission into hospice program and date of discharge (through death or dis-enrollment)
measure: Aggressiveness of Care at the End of Life
time frame: At month 46
description: For patients who have died within the follow up period this outcome assesses aggressiveness of care at the end of life using a composite measure comprised of the following: chemotherapy within 14 days of death no hospice hospice within 3 days of death
measure: Change in Quality of Life
time frame: Baseline and 3 months after enrollment
description: McGill Quality of Life questionnaire (MQOL) will be used at baseline and at 3 months after enrollment. The MQOL is specifically designed for a palliative care population, measuring whole-person concerns magnified by advanced life-limiting illness. It is short, reliable, repeatable, and can be used to determine changes in QOL of groups.
arm group label: Navigation
arm group type: Experimental
description: Participants randomized to the control arm of the study will receive a packet of written materials that are appropriate linguistically and written for individuals with low health literacy. In addition they will have 5 navigator initiated home visits to review the educational materials and help patients and families address barriers to palliative care through education, advocacy, and activation.
arm group label: Control
arm group type: No Intervention
description: Participants randomized to the control arm of the study will receive a packet of written materials that are appropriate linguistically and written for individuals with low health literacy.
intervention type: Behavioral
intervention name: Navigation
description: As per Arm description
arm group label: Navigation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Stacy M Fischer, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor