xml: <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/NCT06035549</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0560</org_study_id>
      <secondary_id>KC_Awd_114452</secondary_id>
      <nct_id>NCT06035549</nct_id>
    </id_info>
    <brief_title>Resilience in East Asian Immigrants</brief_title>
    <official_title>Development of a Culturally Tailored Digital Resilience-Building Intervention for East Asian Immigrants With Cancer to Facilitate Advance Care Planning Discussions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Illinois at Chicago</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Rockefeller University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Illinois at Chicago</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>
        The purpose of the study is to develop a culturally tailored digital resilience-building&#xD;
        intervention to help East Asian immigrants engage in advance care planning discussions with&#xD;
        their family caregivers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Advance care planning (ACP) is a process to facilitate decision-making for future care and&#xD;
        document values and preferences. However, the advance directive completion rates in East&#xD;
        Asian Americans are low, which may extend to disparities in end-of-life care, including rates&#xD;
        of hospice use and prevalence of unwanted aggressive treatments. To address this, this study&#xD;
        uses information technology to develop a culturally tailored digital resilience-building&#xD;
        intervention with and for East Asian immigrants to help them engage in ACP discussions. There&#xD;
        are two aims of this study: (1) Conduct semi-structured interviews with a total of 30&#xD;
        religious leaders to identify the barriers and facilitators associated with discussing ACP&#xD;
        and death-related topics with immigrants from China/Taiwan, Japan, and Korea and (2) Develop&#xD;
        a culturally tailored digital resilience-building intervention using think-aloud interviews&#xD;
        with 27 pairs of East Asian immigrants with cancer and their family caregivers (9 pairs each&#xD;
        for immigrants from China/Taiwan, Japan, and Korea).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Usability</measure>
      <time_frame>Immediately at the end of the think-aloud interview</time_frame>
      <description>Use the System Usability Scale to assess the usability of the intervention</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptability</measure>
      <time_frame>Immediately at the end of the think-aloud interview</time_frame>
      <description>Use the Acceptability E-scale to assess the acceptability of the intervention</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Neoplasms</condition>
    <condition>Advance Care Planning</condition>
    <arm_group>
      <arm_group_label>Culturally Tailored Digital Resilience-Building</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Culturally Tailored Resilience-Building intervention will be provided to East Asian immigrants with cancer and their family caregivers.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Culturally Tailored Digital Resilience-Building</intervention_name>
      <description>The Culturally Tailored Digital Resilience-Building intervention consists of 6 modules, including an introduction of advance care planning and resilience skills that specifically address cultural beliefs and barriers.</description>
      <arm_group_label>Culturally Tailored Digital Resilience-Building</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for Patients:&#xD;
  &#xD;
            -  Immigrants will be eligible for the study if they (1) are ≥ 18 years of age; (2) have&#xD;
               a cancer diagnosis documented in the electronic medical record; (3) are able to read&#xD;
               and respond to questions in English, Mandarin, Cantonese, Japanese, or Korean; (4)&#xD;
               have a family caregiver willing to participate in the study; and (5) have adequate&#xD;
               electronic health literacy with a score of &gt; 30 on the electronic-Health Literacy&#xD;
               Scale.&#xD;
  &#xD;
          Exclusion Criteria for Patients:&#xD;
  &#xD;
            -  Patients who (1) have cognitive impairment per a Short Portable Mental Status&#xD;
               Questionnaire with more than three errors; (2) have completed an advance directive; or&#xD;
               (3) were born in the US.&#xD;
  &#xD;
          Inclusion Criteria for Family Caregivers:&#xD;
  &#xD;
            -  Family caregivers will be eligible if they (1) are ≥ 18 years of age; (2) are able to&#xD;
               read and respond to questions in English, Mandarin, Cantonese, Japanese, or Korean;&#xD;
               (3) are identified by the patient as a family caregiver; and (4) have adequate&#xD;
               electronic health literacy with a score of &gt; 30 on the electronic-Health Literacy&#xD;
               Scale.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
      <investigator_full_name>Li-Ting Longcoy</investigator_full_name>
      <investigator_title>Postdoctoral Research Associate</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035549
  org study id: 2023-0560
  secondary id: KC_Awd_114452
  nct id: NCT06035549
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to develop a culturally tailored digital resilience-building
        intervention to help East Asian immigrants engage in advance care planning discussions with
        their family caregivers.
  Advance care planning (ACP) is a process to facilitate decision-making for future care and
        document values and preferences. However, the advance directive completion rates in East
        Asian Americans are low, which may extend to disparities in end-of-life care, including rates
        of hospice use and prevalence of unwanted aggressive treatments. To address this, this study
        uses information technology to develop a culturally tailored digital resilience-building
        intervention with and for East Asian immigrants to help them engage in ACP discussions. There
        are two aims of this study: (1) Conduct semi-structured interviews with a total of 30
        religious leaders to identify the barriers and facilitators associated with discussing ACP
        and death-related topics with immigrants from China/Taiwan, Japan, and Korea and (2) Develop
        a culturally tailored digital resilience-building intervention using think-aloud interviews
        with 27 pairs of East Asian immigrants with cancer and their family caregivers (9 pairs each
        for immigrants from China/Taiwan, Japan, and Korea).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Usability
  time frame: Immediately at the end of the think-aloud interview
  description: Use the System Usability Scale to assess the usability of the intervention
  measure: Acceptability
  time frame: Immediately at the end of the think-aloud interview
  description: Use the Acceptability E-scale to assess the acceptability of the intervention
  arm group label: Culturally Tailored Digital Resilience-Building
  arm group type: Experimental
  description: The Culturally Tailored Resilience-Building intervention will be provided to East Asian immigrants with cancer and their family caregivers.
  intervention type: Behavioral
  intervention name: Culturally Tailored Digital Resilience-Building
  description: The Culturally Tailored Digital Resilience-Building intervention consists of 6 modules, including an introduction of advance care planning and resilience skills that specifically address cultural beliefs and barriers.
  arm group label: Culturally Tailored Digital Resilience-Building
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: University of Illinois at Chicago
  investigator full name: Li-Ting Longcoy
  investigator title: Postdoctoral Research Associate