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Improving Health Insurance Experiences for Adolescent and Young Adult Cancer Patients (HIAYA CHAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448678
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : September 2, 2022
Sponsor:
Collaborators:
Intermountain Health Care, Inc.
Massachusetts General Hospital
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Anne Kirchhoff, University of Utah

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adolescent Young Adult Cancer Behavioral: Health Insurance Education Program (HIEP) Other: Usual Care Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Health Services Research
Official Title: Huntsman Intermountain Adolescent and Young Adult Cancer Care Program- Cancer Health Insurance Tool Study
Actual Study Start Date : October 21, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Insurance

Arm Intervention/treatment
Experimental: HIEP intervention
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.
Behavioral: Health Insurance Education Program (HIEP)
[See arm/group descriptions]

Active Comparator: Usual Care
Participants will be randomized to receive standard navigation provided by patient navigators ("usual care").
Other: Usual Care
[See arm/group descriptions]




Primary Outcome Measures :
  1. Feasibility Measurement [ Time Frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks)) ]
    Number of eligible enrolled and sessions completed

  2. Acceptability - Module Satisfaction [ Time Frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks)) ]
    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.

  3. Navigator satisfaction [ Time Frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks)) ]
    Validated Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I) measure at post assessment survey. We will report the mean and standard deviation.


Secondary Outcome Measures :
  1. Changes in Efficacy- Health Insurance Literacy [ Time Frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks)) ]
    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.

  2. Changes in Efficacy- Affordable Care Act (ACA) Familiarity [ Time Frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks)) ]
    Question surrounding familiarity with the ACA reported at the baseline and post-assessment survey. We will report percentages of responses.

  3. Changes in Efficacy-Financial Distress [ Time Frame: Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks)) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Were diagnosed with cancer between the ages of 18 and 39 AND
  • Are within 1 year of a cancer diagnosis AND
  • Are actively receiving chemotherapy, surgery, radiation, and/or hormonal therapy AND
  • Are currently insured AND
  • A patient at Primary Children's Hospital, Intermountain Medical Center or Huntsman Cancer Institute AND
  • Speak English AND
  • Have access to an electronic device compatible with video conferencing (e.g., smartphone, laptop, etc.).

Exclusion Criteria:

  • Are unable to participate due to developmental delay OR
  • Speak a language other than English OR
  • Are currently uninsured OR
  • Do not have access to an electronic device compatible with video conferencing (e.g., smartphone, laptop, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448678


Contacts
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Contact: Karely Mann, BS 801-587-4019 karely.mann@hci.utah.edu
Contact: Austin R Waters, HBS 801-213-5758 austin.waters@hci.utah.edu

Locations
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United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Karely Mann, BS    801-587-4019    karely.mann@hci.utah.edu   
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Karely Mann, BS    801-587-4019    karely.mann@hci.utah.edu   
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Karely Mann, BS    801-587-4019    karely.mann@hci.utah.edu   
Sponsors and Collaborators
University of Utah
Intermountain Health Care, Inc.
Massachusetts General Hospital
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anne C Kirchhoff, PhD, MPH University of Utah Department of Pediatrics
  Study Documents (Full-Text)

Documents provided by Anne Kirchhoff, University of Utah:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne Kirchhoff, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04448678    
Other Study ID Numbers: IRB_00127029
1R01CA242729-01 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Kirchhoff, University of Utah:
Education
Insurance