<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/NCT03763032</url>
  </required_header>
  <id_info>
    <org_study_id>17-1955.cc</org_study_id>
    <nct_id>NCT03763032</nct_id>
  </id_info>
  <brief_title>Psychosocial Intervention in Latino Patients With Advanced Cancer</brief_title>
  <official_title>Expanding the Reach of Palliative Care: Pilot Study of a Psychosocial Intervention in Latino Patients With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Palliative Care focuses on symptom management and quality of life and helps patients with&#xD;
      life-limiting illness match goals and preferences for care. While there has been interest in&#xD;
      and acknowledgement that palliative care is an important part of training patient navigators,&#xD;
      there have been no previous studies examining the effectiveness of a navigation intervention&#xD;
      to improve palliative care for patients. This study will examine the feasibility to implement&#xD;
      patient navigator and psychosocial interventions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 23, 2018</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All patients will be assigned a patient navigator, who will provide a psychosocial assessment and palliative counselling</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Because this is a pilot study, all participants will be receiving the same intervention and no blinding will take place.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of Recruitment: number of patients that are eligible to participate</measure>
    <time_frame>Start of study to end of study, up to 12 months</time_frame>
    <description>Assess how likely patients are to join the study through tracking the number of patients that are eligible to participate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of Completion: number of patients that complete the study</measure>
    <time_frame>Start of study to end of study, up to 12 months</time_frame>
    <description>Assess how likely patients are to adhere to the study through tracking the number of patients that complete the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Process Measure Assessment</measure>
    <time_frame>Start of study to end of study, up to 12 months</time_frame>
    <description>Use the Advance Care Planning Engagement Survey to assess Behavior. 9 item questionnaire based on Change Theory using a 6 point Likert scale. Total score is a mean of all items with a range of 1-6.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>FACT-G Quality of Life Assessment</measure>
    <time_frame>Start of study to end of study, up to 12 months</time_frame>
    <description>Assess each patient's quality of life through the Function Assessment of Chronic Illness Therapy-General (FACT-G), which is a 27 question self-reporting measure of quality of life. Scale range is 0-108, higher scores indicating higher quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression Assessment</measure>
    <time_frame>Start of study to end of study, up to 12 months</time_frame>
    <description>Use the Patient Health Questionnaire-8 to measure depressive symptoms through an 8 item assessment. Score ranges are 0-24, higher scores representing more depressive symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety Assessment</measure>
    <time_frame>Start of study to end of study, up to 12 months</time_frame>
    <description>Use the Generalize Anxiety Disorder-7 to measure symptoms of anxiety through a 7 question assessment. Score range is 0-21, with increased scores representing higher levels of anxiety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Assessment: PEG questionnaire</measure>
    <time_frame>Start of study to end of study, up to 12 months</time_frame>
    <description>The PEG questionnaire assesses pain intensity and interference on a numeric rating scale. Scale range of each of three items is 0-10. Total score is the mean of the three item scores.</description>
  </other_outcome>
  <other_outcome>
    <measure>Symptom Severity Assessment</measure>
    <time_frame>Start of study to end of study, up to 12 months</time_frame>
    <description>Use the Edmonton Symptom Assessment Scale (ESAS-r) to assess symptom severity on a numeric rating scale. Score range for each of the 9 items is 0-10 with total score summary of all individual symptom items.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital Assessments</measure>
    <time_frame>Start of study to end of study, up to 12 months</time_frame>
    <description>Evaluate the frequency of hospitalizations or deaths through patient medical records</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Stepped Interventions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient navigation intervention, plus various psychosocial interventions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counseling</intervention_name>
    <description>The patient navigator will provide educational materials, assessments, and counseling to the patients</description>
    <arm_group_label>Stepped Interventions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults ages &gt; or = 18 years of age&#xD;
&#xD;
          -  Must self-identify as Latino/a&#xD;
&#xD;
          -  Have stage III/IV cancer&#xD;
&#xD;
          -  Seeking or In treatment for their cancer (ie: not in hospice care)&#xD;
&#xD;
          -  Not incarcerated&#xD;
&#xD;
          -  Have at least moderate baseline distress (&gt; 4 on the NCCN Distress Thermometer) or&#xD;
             positive screen for depression (PHQ-2 score &gt;=3) or anxiety (GAD-2 score &gt;=3)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -No exclusion criteria listed&#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>Stacy Fischer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Bekelman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Palliative Care</keyword>
  <keyword>Latino</keyword>
  <keyword>Psychosocial Intervention</keyword>
  <keyword>Patient Navigation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT03763032
org study id: 17-1955.cc
nct id: NCT03763032
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Palliative Care focuses on symptom management and quality of life and helps patients with
      life-limiting illness match goals and preferences for care. While there has been interest in
      and acknowledgement that palliative care is an important part of training patient navigators,
      there have been no previous studies examining the effectiveness of a navigation intervention
      to improve palliative care for patients. This study will examine the feasibility to implement
      patient navigator and psychosocial interventions.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All patients will be assigned a patient navigator, who will provide a psychosocial assessment and palliative counselling
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Because this is a pilot study, all participants will be receiving the same intervention and no blinding will take place.
measure: Feasibility of Recruitment: number of patients that are eligible to participate
time frame: Start of study to end of study, up to 12 months
description: Assess how likely patients are to join the study through tracking the number of patients that are eligible to participate.
measure: Feasibility of Completion: number of patients that complete the study
time frame: Start of study to end of study, up to 12 months
description: Assess how likely patients are to adhere to the study through tracking the number of patients that complete the study.
measure: Process Measure Assessment
time frame: Start of study to end of study, up to 12 months
description: Use the Advance Care Planning Engagement Survey to assess Behavior. 9 item questionnaire based on Change Theory using a 6 point Likert scale. Total score is a mean of all items with a range of 1-6.
measure: FACT-G Quality of Life Assessment
time frame: Start of study to end of study, up to 12 months
description: Assess each patient's quality of life through the Function Assessment of Chronic Illness Therapy-General (FACT-G), which is a 27 question self-reporting measure of quality of life. Scale range is 0-108, higher scores indicating higher quality of life.
measure: Depression Assessment
time frame: Start of study to end of study, up to 12 months
description: Use the Patient Health Questionnaire-8 to measure depressive symptoms through an 8 item assessment. Score ranges are 0-24, higher scores representing more depressive symptoms.
measure: Anxiety Assessment
time frame: Start of study to end of study, up to 12 months
description: Use the Generalize Anxiety Disorder-7 to measure symptoms of anxiety through a 7 question assessment. Score range is 0-21, with increased scores representing higher levels of anxiety.
measure: Pain Assessment: PEG questionnaire
time frame: Start of study to end of study, up to 12 months
description: The PEG questionnaire assesses pain intensity and interference on a numeric rating scale. Scale range of each of three items is 0-10. Total score is the mean of the three item scores.
measure: Symptom Severity Assessment
time frame: Start of study to end of study, up to 12 months
description: Use the Edmonton Symptom Assessment Scale (ESAS-r) to assess symptom severity on a numeric rating scale. Score range for each of the 9 items is 0-10 with total score summary of all individual symptom items.
measure: Hospital Assessments
time frame: Start of study to end of study, up to 12 months
description: Evaluate the frequency of hospitalizations or deaths through patient medical records
arm group label: Stepped Interventions
arm group type: Experimental
description: Patient navigation intervention, plus various psychosocial interventions
intervention type: Behavioral
intervention name: Counseling
description: The patient navigator will provide educational materials, assessments, and counseling to the patients
arm group label: Stepped Interventions
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stacy Fischer, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: David Bekelman, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms