Clinical trial NCT04448678: Improving Health Insurance Experiences for Adolescent and Young Adult Cancer Patients
Official title: Huntsman Intermountain Adolescent and Young Adult Cancer Care Program- Cancer Health Insurance Tool Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent
Young Adult
Cancer
Keywords: Education
Insurance
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Intermountain Health Care, Inc.
name: Massachusetts General Hospital
name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2020-06-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.).

Primary outcomes:
measure: Feasibility Measurement
timeFrame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
measure: Acceptability - Module Satisfaction
timeFrame: Post-Assessment interview (Weeks 18 (+/- 2 weeks))
measure: Navigator Satisfaction
timeFrame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
Secondary outcomes:
measure: Changes in Efficacy- Health Insurance Literacy
timeFrame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
measure: Changes in Efficacy- Affordable Care Act (ACA) Familiarity
timeFrame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
measure: Changes in Efficacy-Financial Distress
timeFrame: Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: University of Utah Department of Pediatrics
name: Anne C Kirchhoff, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.