Clinical trial NCT05829070: Improving Health Insurance Literacy Among Young Adult Cancer Survivors
Official title: A Randomized Controlled Trial to Improve Health Insurance Literacy and Surveillance Among Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Intermountain Health
name: Massachusetts General Hospital
First posted: 2023-04-25
Enrollment: 300
Sex: ALL
Minimum age (years): 26
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We will conduct a randomized controlled trial to test a 4-session virtual health insurance navigation intervention that will increase knowledge about health insurance, reduce financial burden, and improve surveillance for recurrence among 300 young adult cancer survivors ages 26 to 39. We will combine self-reported survey data with electronic health records and claims data to examine the trial outcomes and efficacy. We will also conduct an economic evaluation using cost-effectiveness and budget impact analyses, to establish the sustainability of the intervention at improving outcomes of young adult survivors through increasing their health insurance knowledge and decreasing their financial burden.

Detailed description: The first year after cancer treatment ends is a critical time to establish survivorship care for young adult (YA) cancer survivors ages 26 to 39. Receipt of evidence-based survivorship care, including surveillance for cancer recurrence based on national guidelines, remain low among YA survivors. At the same time, YAs ages 26 to 39 have the highest rate of both uninsurance and underinsurance among adults in the United States. Our team's prior work demonstrated that YA cancer survivors report low understanding of their health insurance and the services it covers, which affects their ability to navigate care. Together, these issues can lead to significant access to care barriers and severe medical cost consequences for this population. This proposal addresses the urgent need to improve YA cancer survivors' health insurance literacy and decrease financial toxicity, thus improving their ability to receive recommended survivorship care. Guided by Andersen and Aday's Behavioral Model of Health Services Use, we developed and pilot-tested a 4-session virtual patient navigation intervention for YA cancer survivors that was adapted from a pilot program for childhood cancer survivors. Initial results support feasibility, acceptability, and preliminary efficacy of both of these pilot trials with YA survivors ages 26 to 39. We now propose a randomized controlled trial to test the efficacy of this program ("CHAT-S," Cancer Health insurAnce Tools with Survivors) to improve health insurance literacy, financial toxicity due to medical costs, and post-treatment surveillance for recurrence among YA cancer survivors ages 26 to 39 (up to age 45). We plan to randomize N=300 (N=200 intervention; N=100 usual care) YAs with breast, testicular, lymphoma, sarcoma, and colorectal cancer who have completed initial treatment within the past year from 14 locations in the University of Utah Healthcare (UUHC) and Intermountain Healthcare (IH) systems. UUHC and IH have many rural (20%) and Hispanic/Latinx (18%) YA cancer survivors; we will oversample these important subgroups. We will determine whether CHAT-S improves health insurance literacy and financial toxicity at 6-month follow-up (primary outcomes). Further, UUHC and IH have an integrated data infrastructure which allows us to capture electronic health records and claims data to investigate whether CHAT-S improves surveillance care for recurrence at 18-month follow-up (secondary outcome). We will explore moderators (e.g., rurality, ethnicity) of the intervention effects. Finally, to inform future dissemination, we will conduct a budget impact analysis and a short-term and long-term time horizon cost-effectiveness analysis of CHAT-S. This proposal addresses the National Cancer Institute's goal of improving the care of cancer survivors and mitigating financial toxicity. We will demonstrate that a virtual health insurance literacy intervention can improve insurance literacy, financial toxicity, and surveillance care among YA cancer survivors, and provide guidance to improving survivorship care across the United States.

Eligibility criteria: Inclusion Criteria:

Participants are eligible for this study if they:

1. Were diagnosed with breast, testicular, lymphoma, sarcoma, and colorectal cancer,
2. Are between the ages of 26 to 45 years (preferably between 26-39, but no older than 45),
3. Have completed initial treatment (i.e., radiation, chemotherapy, or surgery) within the past year,
4. Are a patient at the University of Utah/Huntsman Cancer Institute or Intermountain Healthcare, and
5. Speak English.

Exclusion Criteria:

Potential participants will be excluded if they:

1. Are unable to participate due to developmental delay, and
2. Speak a language other than English, and
3. Unable to participate through either phone or a video capable computer or mobile device (e.g., smartphone, laptop, etc.).

Primary outcomes:
measure: Health Insurance Literacy Measure (HILM)
timeFrame: Baseline
measure: COmprehensive Score for financial Toxicity (COST)
timeFrame: Baseline
measure: Health Insurance Literacy Measure
timeFrame: 6 months
measure: COmprehensive Score for financial Toxicity (COST)
timeFrame: 6 months
measure: Health Insurance Literacy Measure
timeFrame: 12 months
measure: COmprehensive Score for financial Toxicity (COST)
timeFrame: 12 months
Secondary outcomes:
measure: Surveillance for Recurrence
timeFrame: 18 months
measure: Survivorship Care Receipt
timeFrame: 18 months
measure: Insurance Coverage
timeFrame: Baseline
measure: Insurance Coverage
timeFrame: 6 months
measure: Insurance Coverage
timeFrame: 12 months
measure: Familiarity with the Affordable Care Act and other insurance legislation
timeFrame: Baseline
measure: Familiarity with the Affordable Care Act and other insurance legislation
timeFrame: 6 months
measure: Familiarity with the Affordable Care Act and other insurance legislation
timeFrame: 12 months
measure: Feasibility of enrollment and session completion
timeFrame: 6 months
measure: Acceptability:
timeFrame: 6 months
measure: Patient Satisfaction with Interpersonal Relationship with Navigator
timeFrame: 6 months
measure: Cost related literacy
timeFrame: Baseline
measure: Cost related literacy
timeFrame: 6 months
measure: Cost related literacy
timeFrame: 12 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: