Improving Health Insurance Experiences for Adolescent and Young Adult Cancer Patients

NCT ID: NCT04448678

Last Updated: 2024-01-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2022-09-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adolescent Young Adult Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Health Insurance Education Program (HIEP)

Intervention Type BEHAVIORAL

\[See arm/group descriptions\]

Usual Care

Participants will be randomized to receive standard navigation provided by patient navigators ("usual care").

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

\[See arm/group descriptions\]

Interventions

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Health Insurance Education Program (HIEP)

\[See arm/group descriptions\]

Intervention Type BEHAVIORAL

Usual Care

\[See arm/group descriptions\]

Intervention Type OTHER

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intermountain Health Care, Inc.

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Anne Kirchhoff

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne C Kirchhoff, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Utah Department of Pediatrics

Locations

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Intermountain Medical Center

Murray, Utah, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Primary Children's Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Vaca Lopez PL, Warner EL, Waters AR, van Thiel Berghuijs KM, Anderson JS, Ray N, Tsukamoto T, Kaddas HK, Fair D, Lewis M, Park ER, Perez GK, Kirchhoff AC. Adaptation and Development of a Health Insurance Education Program for Adolescent and Young Adult Cancer Patients. J Adolesc Young Adult Oncol. 2023 Oct;12(5):692-700. doi: 10.1089/jayao.2022.0103. Epub 2023 Jan 27.

Reference Type DERIVED
PMID: 36706435 (View on PubMed)

Mann K, Waters AR, Park ER, Perez GK, Vaca Lopez PL, Kaddas HK, Warner EL, Ray N, Tsukamoto T, Allen K, Haaland B, Fair DB, Lewis MA, Kirchhoff AC. HIAYA CHAT study protocol: a randomized controlled trial of a health insurance education intervention for newly diagnosed adolescent and young adult cancer patients. Trials. 2022 Aug 19;23(1):682. doi: 10.1186/s13063-022-06590-5.

Reference Type DERIVED
PMID: 35986416 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: UniversityofUtah

View Document

Document Type: Informed Consent Form: IntermountainHealthCare

View Document

Other Identifiers

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1R01CA242729-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB_00127029

Identifier Type: -

Identifier Source: org_study_id

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