<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/NCT04448678</url>
  </required_header>
  <id_info>
    <org_study_id>IRB_00127029</org_study_id>
    <secondary_id>1R01CA242729-01</secondary_id>
    <nct_id>NCT04448678</nct_id>
  </id_info>
  <brief_title>Improving Health Insurance Experiences for Adolescent and Young Adult Cancer Patients</brief_title>
  <acronym>HIAYA CHAT</acronym>
  <official_title>Huntsman Intermountain Adolescent and Young Adult Cancer Care Program- Cancer Health Insurance Tool Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a test of an existing health insurance education program (HIEP) in adolescent and&#xD;
      young adult (AYA) individuals (aged 18-39) diagnosed with cancer. The study will evaluate&#xD;
      whether the HIEP delivered by patient navigators improves participants' health insurance and&#xD;
      cost-related literacy compared to usual navigation care, which does not include education on&#xD;
      insurance and medical costs. The study team hypothesizes that: The HIEP will improve&#xD;
      participants' health insurance and cost-related literacy compared to usual navigation care.&#xD;
      Specifically, that participants in the intervention arm will report greater 1) health&#xD;
      insurance and cost literacy, including confidence with provider communication about costs, 2)&#xD;
      familiarity with ACA policies, and 3) improvement in financial distress related to medical&#xD;
      costs. Participants will fill out a survey upon enrollment and a follow up survey 3 months&#xD;
      after meeting with a patient navigator where they may or may not receive the HIEP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this research is to refine and pilot test an existing health insurance education&#xD;
      program (HIEP) to improve health insurance and cost-related literacy among adolescent and&#xD;
      young adult (AYA) individuals who have recently been diagnosed with cancer. This study will&#xD;
      be conducted within the Huntsman-Intermountain Adolescent and Young Adult (HI-AYA) Cancer&#xD;
      Care Program, which is a unique collaboration between the Huntsman Cancer Institute and&#xD;
      Intermountain Healthcare, the largest oncology providers in Utah. Initially, age-related&#xD;
      differences related to health insurance and cost literacy among AYAs diagnosed with cancer&#xD;
      ages 18-26 and 27-39 years will be identified, and the HIEP materials will be adapted&#xD;
      accordingly. The HIEP delivered by the HI-AYA patient navigators, will be investigated to see&#xD;
      if it improves participants' health insurance and cost-related literacy.&#xD;
&#xD;
      Upon enrollment, participants will fill out a survey containing questions about their current&#xD;
      health insurance plan, financial status, demographics, health insurance knowledge, and&#xD;
      financial toxicity. Participants will then be randomized into separate trial arms after which&#xD;
      participants in both groups will meet with a HI-AYA patient navigator. Participants in the&#xD;
      interventional arm will receive 4 educational sessions surrounding health insurance use and&#xD;
      laws (four sessions total occurring approximately every two weeks). These educational&#xD;
      sessions will be conducted, in person, over video conference calls, or over the telephone,&#xD;
      and will cover:&#xD;
&#xD;
        -  health insurance terms and concepts&#xD;
&#xD;
        -  insurance coverage (insurance cards, bills, schedule and explanation on benefits)&#xD;
&#xD;
        -  health insurance laws, rights and the appeals process&#xD;
&#xD;
        -  budgeting and resources. These sessions will be scheduled with each participant&#xD;
           according to their availability, with the goal of meeting every other week.&#xD;
&#xD;
      Approximately three months after meeting with the patient navigator, participants in both&#xD;
      arms of the trial will fill out a second survey, including similar questions to those in the&#xD;
      first survey as well as questions surrounding satisfaction with the HIEP and the patient&#xD;
      navigator delivery for those who received the HIEP. After the post survey is complete, a&#xD;
      small subset of participants in both the intervention and control arm will be randomly&#xD;
      selected to complete an interview to better understand satisfaction with patient navigation,&#xD;
      the intervention, recommendations for modifications on delivery modality, and recommendations&#xD;
      for intervention topics and content modifications to identify components of the HIEP that&#xD;
      require refinement prior to potential scaling of the intervention to a larger sample. Another&#xD;
      small subset of participants will be randomly selected to complete an interview from the&#xD;
      control arm to discuss their satisfaction with their patient navigation and to ask how they&#xD;
      found resources concerning health insurance during their treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 21, 2020</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants will not know who is receiving additional health insurance navigation or standard navigation. The outcome assessor will also be blinded to which participants received health insurance navigation. Blinding for the outcome assessor will be kept throughout the entirety of the analysis. Groups will be identified for analysis with ambiguous categories such as group 1 and group 2.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility Measurement</measure>
    <time_frame>Post-Assessment survey (Weeks 13 (+/- 2 weeks))</time_frame>
    <description>Number of eligible enrolled and sessions completed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability - Module Satisfaction</measure>
    <time_frame>Post-Assessment survey (Weeks 13 (+/- 2 weeks))</time_frame>
    <description>Questions surrounding satisfaction with the HIEP. These will be asked at the post-assessment survey and will consist of 5-point scales of satisfaction. We will report percentages of participants reporting satisfaction of each response.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Navigator satisfaction</measure>
    <time_frame>Post-Assessment survey (Weeks 13 (+/- 2 weeks))</time_frame>
    <description>Validated Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I) measure at post assessment survey. We will report the mean and standard deviation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Efficacy- Health Insurance Literacy</measure>
    <time_frame>Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))</time_frame>
    <description>Differences between Health Insurance Literacy Measure (HILM) reported at the intro baseline and exit post-assessment survey. Differences will be examined by age group and by treatment arm. Lower HILM scores indicate lower health insurance literacy. We will report mean and standard deviation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Efficacy- Affordable Care Act (ACA) Familiarity</measure>
    <time_frame>Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))</time_frame>
    <description>Question surrounding familiarity with the ACA reported at the baseline and post-assessment survey. We will report percentages of responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Efficacy-Financial Distress</measure>
    <time_frame>Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))</time_frame>
    <description>Differences between COmprehensive Score for financial Toxicity (COST) reported at the baseline and post-assessment survey. Lower COST scores indicate worse financial toxicity. Differences will be examined by age group and by treatment arm. We will report mean and standard deviation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Adolescent</condition>
  <condition>Young Adult</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>HIEP intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive the insurance navigation intervention from patient navigators, which includes four, one hour long, educational learning sessions. Randomization will be done by age at diagnosis and site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomized to receive standard navigation provided by patient navigators (&quot;usual care&quot;).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Insurance Education Program (HIEP)</intervention_name>
    <description>[See arm/group descriptions]</description>
    <arm_group_label>HIEP intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>[See arm/group descriptions]</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Were diagnosed with cancer between the ages of 18 and 39 AND&#xD;
&#xD;
          -  Are within 1 year of a cancer diagnosis AND&#xD;
&#xD;
          -  Are actively receiving chemotherapy, surgery, radiation, and/or hormonal therapy AND&#xD;
&#xD;
          -  Are currently insured AND&#xD;
&#xD;
          -  A patient at Primary Children's Hospital, Intermountain Medical Center or Huntsman&#xD;
             Cancer Institute AND&#xD;
&#xD;
          -  Speak English AND&#xD;
&#xD;
          -  Have access to an electronic device compatible with video conferencing (e.g.,&#xD;
             smartphone, laptop, etc.).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are unable to participate due to developmental delay OR&#xD;
&#xD;
          -  Speak a language other than English OR&#xD;
&#xD;
          -  Are currently uninsured OR&#xD;
&#xD;
          -  Do not have access to an electronic device compatible with video conferencing (e.g.,&#xD;
             smartphone, laptop, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne C Kirchhoff, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah Department of Pediatrics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karely Mann, BS</last_name>
    <phone>801-587-4019</phone>
    <email>karely.mann@hci.utah.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Austin R Waters, HBS</last_name>
    <phone>801-213-5758</phone>
    <email>austin.waters@hci.utah.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karely Mann, BS</last_name>
      <phone>801-587-4019</phone>
      <email>karely.mann@hci.utah.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karely Mann, BS</last_name>
      <phone>801-587-4019</phone>
      <email>karely.mann@hci.utah.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karely Mann, BS</last_name>
      <phone>801-587-4019</phone>
      <email>karely.mann@hci.utah.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>August 31, 2022</last_update_submitted>
  <last_update_submitted_qc>August 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Anne Kirchhoff</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Education</keyword>
  <keyword>Insurance</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form: UniversityofUtah</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT04448678/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: IntermountainHealthCare</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT04448678/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04448678
org study id: IRB_00127029
secondary id: 1R01CA242729-01
nct id: NCT04448678
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a test of an existing health insurance education program (HIEP) in adolescent and
      young adult (AYA) individuals (aged 18-39) diagnosed with cancer. The study will evaluate
      whether the HIEP delivered by patient navigators improves participants' health insurance and
      cost-related literacy compared to usual navigation care, which does not include education on
      insurance and medical costs. The study team hypothesizes that: The HIEP will improve
      participants' health insurance and cost-related literacy compared to usual navigation care.
      Specifically, that participants in the intervention arm will report greater 1) health
      insurance and cost literacy, including confidence with provider communication about costs, 2)
      familiarity with ACA policies, and 3) improvement in financial distress related to medical
      costs. Participants will fill out a survey upon enrollment and a follow up survey 3 months
      after meeting with a patient navigator where they may or may not receive the HIEP.
The goal of this research is to refine and pilot test an existing health insurance education
      program (HIEP) to improve health insurance and cost-related literacy among adolescent and
      young adult (AYA) individuals who have recently been diagnosed with cancer. This study will
      be conducted within the Huntsman-Intermountain Adolescent and Young Adult (HI-AYA) Cancer
      Care Program, which is a unique collaboration between the Huntsman Cancer Institute and
      Intermountain Healthcare, the largest oncology providers in Utah. Initially, age-related
      differences related to health insurance and cost literacy among AYAs diagnosed with cancer
      ages 18-26 and 27-39 years will be identified, and the HIEP materials will be adapted
      accordingly. The HIEP delivered by the HI-AYA patient navigators, will be investigated to see
      if it improves participants' health insurance and cost-related literacy.

      Upon enrollment, participants will fill out a survey containing questions about their current
      health insurance plan, financial status, demographics, health insurance knowledge, and
      financial toxicity. Participants will then be randomized into separate trial arms after which
      participants in both groups will meet with a HI-AYA patient navigator. Participants in the
      interventional arm will receive 4 educational sessions surrounding health insurance use and
      laws (four sessions total occurring approximately every two weeks). These educational
      sessions will be conducted, in person, over video conference calls, or over the telephone,
      and will cover:

        -  health insurance terms and concepts

        -  insurance coverage (insurance cards, bills, schedule and explanation on benefits)

        -  health insurance laws, rights and the appeals process

        -  budgeting and resources. These sessions will be scheduled with each participant
           according to their availability, with the goal of meeting every other week.

      Approximately three months after meeting with the patient navigator, participants in both
      arms of the trial will fill out a second survey, including similar questions to those in the
      first survey as well as questions surrounding satisfaction with the HIEP and the patient
      navigator delivery for those who received the HIEP. After the post survey is complete, a
      small subset of participants in both the intervention and control arm will be randomly
      selected to complete an interview to better understand satisfaction with patient navigation,
      the intervention, recommendations for modifications on delivery modality, and recommendations
      for intervention topics and content modifications to identify components of the HIEP that
      require refinement prior to potential scaling of the intervention to a larger sample. Another
      small subset of participants will be randomly selected to complete an interview from the
      control arm to discuss their satisfaction with their patient navigation and to ask how they
      found resources concerning health insurance during their treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
masking description: Participants will not know who is receiving additional health insurance navigation or standard navigation. The outcome assessor will also be blinded to which participants received health insurance navigation. Blinding for the outcome assessor will be kept throughout the entirety of the analysis. Groups will be identified for analysis with ambiguous categories such as group 1 and group 2.
measure: Feasibility Measurement
time frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
description: Number of eligible enrolled and sessions completed
measure: Acceptability - Module Satisfaction
time frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
description: Questions surrounding satisfaction with the HIEP. These will be asked at the post-assessment survey and will consist of 5-point scales of satisfaction. We will report percentages of participants reporting satisfaction of each response.
measure: Navigator satisfaction
time frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
description: Validated Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I) measure at post assessment survey. We will report the mean and standard deviation.
measure: Changes in Efficacy- Health Insurance Literacy
time frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
description: Differences between Health Insurance Literacy Measure (HILM) reported at the intro baseline and exit post-assessment survey. Differences will be examined by age group and by treatment arm. Lower HILM scores indicate lower health insurance literacy. We will report mean and standard deviation.
measure: Changes in Efficacy- Affordable Care Act (ACA) Familiarity
time frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
description: Question surrounding familiarity with the ACA reported at the baseline and post-assessment survey. We will report percentages of responses.
measure: Changes in Efficacy-Financial Distress
time frame: Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))
description: Differences between COmprehensive Score for financial Toxicity (COST) reported at the baseline and post-assessment survey. Lower COST scores indicate worse financial toxicity. Differences will be examined by age group and by treatment arm. We will report mean and standard deviation.
arm group label: HIEP intervention
arm group type: Experimental
description: Participants will be randomized to receive the insurance navigation intervention from patient navigators, which includes four, one hour long, educational learning sessions. Randomization will be done by age at diagnosis and site.
arm group label: Usual Care
arm group type: Active Comparator
description: Participants will be randomized to receive standard navigation provided by patient navigators ("usual care").
intervention type: Behavioral
intervention name: Health Insurance Education Program (HIEP)
description: [See arm/group descriptions]
arm group label: HIEP intervention
intervention type: Other
intervention name: Usual Care
description: [See arm/group descriptions]
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Anne C Kirchhoff, PhD, MPH
role: Principal Investigator
affiliation: University of Utah Department of Pediatrics
last name: Karely Mann, BS
phone: 801-587-4019
email: karely.mann@hci.utah.edu
last name: Austin R Waters, HBS
phone: 801-213-5758
email: austin.waters@hci.utah.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Anne Kirchhoff
investigator title: Associate Professor
sharing ipd: No
provided document: 
provided document: 