Improving Health Insurance Literacy Among Young Adult Cancer Survivors

NCT ID: NCT05829070

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-08
• Study Completion Date: 2028-03-31

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

CHAT-S

CHAT-S consists of 4 bi-weekly 35-45 minute videoconferencing sessions with a patient navigator and a patient booklet on insurance, costs, and survivorship care.

Group Type: EXPERIMENTAL

CHAT-S

Intervention Type: BEHAVIORAL

The CHAT-S intervention will include 4 videoconference sessions over a 2-month time period that is delivered by a patient navigator. Session 1 will include content to educate participants about survivorship care and common types of follow-up care required for their specific cancer, as well as, basic insurance terms and concepts. Session 2 will teach participants about their own insurance plan (e.g., coverage, benefits, breakdown of bills, and explanation of benefits) so they can better navigate both the medical and insurance systems. Session 3 reviews health insurance laws (e.g., ACA, FMLA, No Surprises Act) and how to proceed with an appeals process. Session 4 explains how to manage the costs through budgeting and cost-of-care conversations with their medical providers.

Usual Care

Usual care will consist of a resource list sent by the navigator.

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Usual care will consist of a resource list that describes organizational and community resources available on insurance, financial burden, and survivorship care. Further, we will track whether participants were referred or engaged in services using the follow-up surveys and via the EHR/claims data.

Interventions

CHAT-S

The CHAT-S intervention will include 4 videoconference sessions over a 2-month time period that is delivered by a patient navigator. Session 1 will include content to educate participants about survivorship care and common types of follow-up care required for their specific cancer, as well as, basic insurance terms and concepts. Session 2 will teach participants about their own insurance plan (e.g., coverage, benefits, breakdown of bills, and explanation of benefits) so they can better navigate both the medical and insurance systems. Session 3 reviews health insurance laws (e.g., ACA, FMLA, No Surprises Act) and how to proceed with an appeals process. Session 4 explains how to manage the costs through budgeting and cost-of-care conversations with their medical providers.

Intervention Type: BEHAVIORAL

Usual Care

Usual care will consist of a resource list that describes organizational and community resources available on insurance, financial burden, and survivorship care. Further, we will track whether participants were referred or engaged in services using the follow-up surveys and via the EHR/claims data.

Intervention Type: BEHAVIORAL

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.).

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intermountain Health

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Anne Kirchhoff

Associate Professor, Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

R01CA276825

Identifier Type: NIH

Identifier Source: org_study_id

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