NCT04448678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 21, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

June 22, 2020

Results QC Date

October 2, 2023

Last Update Submit

January 2, 2024

Conditions

AdolescentYoung AdultCancer

Keywords

EducationInsurance

Outcome Measures

Primary Outcomes (3)

  • Feasibility Measurement

    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.)

    Post-Assessment survey (Weeks 13 (+/- 2 weeks))

  • Acceptability - Module Satisfaction

    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.

    Post-Assessment interview (Weeks 18 (+/- 2 weeks))

  • Navigator Satisfaction

    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.

    Post-Assessment survey (Weeks 13 (+/- 2 weeks))

Secondary Outcomes (3)

  • Changes in Efficacy- Health Insurance Literacy

    Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))

  • Changes in Efficacy- Affordable Care Act (ACA) Familiarity

    Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))

  • Changes in Efficacy-Financial Distress

    Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))

Study Arms (2)

HIEP intervention

EXPERIMENTAL

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)

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

Health Insurance Education Program (HIEP)BEHAVIORAL

\[See arm/group descriptions\]

HIEP intervention
Usual CareOTHER

\[See arm/group descriptions\]

Usual Care

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.).

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Related Publications (2)

  • 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.

    PMID: 36706435DERIVED

  • 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.

    PMID: 35986416DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

Title
Anne Kirchhoff
Organization
University of Utah
Anne.Kirchhoff@hci.utah.edu
801-587-4084

Study Officials

  • Anne C Kirchhoff, PhD, MPH

    University of Utah Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 26, 2020

Study Start

October 21, 2020

Primary Completion

September 20, 2022

Study Completion

September 20, 2022

Last Updated

January 5, 2024

Results First Posted

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)