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NCT04448678: HIAYA CHAT

Improving Health Insurance Experiences for Adolescent and Young Adult Cancer Patients

Completed NA Results posted Last updated 5 January 2024
What this trial tests

NA trial testing Health Insurance Education Program (HIEP) in Adolescent in 86 participants. Completed in 20 September 2022.

Timeline
21 October 2020
Primary endpoint
20 September 2022
20 September 2022

Quick facts

Lead sponsorUniversity of Utah
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposehealth services research
Enrollment86
Start date21 October 2020
Primary completion20 September 2022
Estimated completion20 September 2022
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Utah

Who can join

Adults 18 to 40, any sex, with Adolescent or Young Adult. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility Measurement Primary · Post-Assessment survey (Weeks 13 (+/- 2 weeks))

Comparing total number of individuals enrolled and randomized vs completed study (completion of both surveys for control or both surveys and all of the sessions for intervention.)

GroupValue95% CI
Usual Care39
HIEP Intervention25
Acceptability - Module Satisfaction Primary · Post-Assessment interview (Weeks 18 (+/- 2 weeks))

Questions surrounding satisfaction with the HIEP. These will be asked at the post-assessment interview and will consist of participants responses surrounding satisfaction with the HIEP. We will report percentages of participants who did 1 or more session and reported satisfaction with the HIEP.

GroupValue95% CI
HIEP Intervention10
Usual Care0
Navigator Satisfaction Primary · Post-Assessment survey (Weeks 13 (+/- 2 weeks))

Validated Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I) measure at post assessment survey. This score ranges from 0-45 with higher scores indicating higher satisfaction. We will report the mean and standard deviation.

GroupValue95% CI
HIEP Intervention30.84± 16.15
Usual Care30.32± 12.95
Changes in Efficacy- Health Insurance Literacy Secondary · 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. For this study, the last two sections (3\&4) of the HILM were used. Scores range from 9-36 with lower scores indicate lower health insurance literacy and worse outcomes. Differences will be examined by age group and by treatment arm. We report mean and standard deviation. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.

GroupValue95% CI
HIEP Intervention5.39± 6.44
Usual Care2.30± 6.06
Combined3.84± 6.40
Changes in Efficacy- Affordable Care Act (ACA) Familiarity Secondary · Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))

Questions surrounding familiarity with the ACA reported at the baseline and post-assessment survey. Values range from 0 to 28 with higher scores indicating better familiarity with ACA concepts. We will report the mean and standard deviation of the difference in response scores between baseline and post assessment for the control and intervention. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.

GroupValue95% CI
HIEP Intervention5.84± 6.30
Usual Care2.03± 4.89
Combined3.93± 5.92
Changes in Efficacy-Financial Distress Secondary · 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. Values range from 0 to 44 where 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. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.

Younger group (18-25)
GroupValue95% CI
HIEP Intervention3.70± 9.59
Usual Care2.89± 9.44
Combined3.32± 9.26
Older group (26-39)
GroupValue95% CI
HIEP Intervention3.08± 8.45
Usual Care0.741± 6.42
Combined1.87± 7.48
Combined (18-39)
GroupValue95% CI
HIEP Intervention3.25± 8.65
Usual Care1.28± 7.20
Combined2.25± 7.95

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Navigating financial toxicity in patients with cancer: A multidisciplinary management approach.
    Smith GL, Banegas MP, Acquati C, Chang S, et al · · 2022 · cited 193× · PMID 35584404 · DOI 10.3322/caac.21730
  2. HIAYA CHAT study protocol: a randomized controlled trial of a health insurance education intervention for newly diagnosed adolescent and young adult cancer patients.
    Mann K, Waters AR, Park ER, Perez GK, et al · · 2022 · cited 26× · PMID 35986416 · DOI 10.1186/s13063-022-06590-5
  3. Health Insurance Literacy Improvements Among Recently Diagnosed Adolescents and Young Adults With Cancer: Results From a Pilot Randomized Controlled Trial.
    Kirchhoff AC, van Thiel Berghuijs KM, Waters AR, Kaddas HK, et al · · 2024 · cited 25× · PMID 38060990 · DOI 10.1200/op.23.00171
  4. Adaptation and Development of a Health Insurance Education Program for Adolescent and Young Adult Cancer Patients.
    Vaca Lopez PL, Warner EL, Waters AR, van Thiel Berghuijs KM, et al · · 2023 · cited 9× · PMID 36706435 · DOI 10.1089/jayao.2022.0103
  5. CHAT-S Study Protocol: A randomized controlled trial of a health insurance literacy education program for young adult cancer survivors.
    Killela M, Turner CA, Chevrier A, Stefanou M, et al · · 2025 · cited 2× · PMID 40821005 · DOI 10.1080/28322134.2025.2455706
  6. Editorial: Financial anxiety in cancer prevention and control.
    Parsons HM, Banegas MP, Bar-Sela G, Jones SM. · · 2023 · PMID 37908816 · DOI 10.3389/fpsyg.2023.1304079

Verify or expand the search:

Other trials of Health Insurance Education Program (HIEP)

Trials testing the same drug.

Other recruiting trials for Adolescent

Currently open trials in the same condition.

Other University of Utah trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04448678.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing