Virtual Health Insurance Navigation for Childhood Cancer Survivors

(HINTII Trial)

Overseen By Elyse R Park, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Pilot trial participants

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help childhood cancer survivors better understand and manage their health insurance. The goal is to determine whether a live, virtual program (HINT-S) or a prerecorded version (HINT-A) of the Health Insurance Navigation Tools Program more effectively reduces worries about medical costs and improves healthcare access. The trial will also compare these methods to standard care, which includes a helpful booklet. Childhood cancer survivors currently in the Long-Term Follow-Up (LTFU) program, with U.S. health insurance and access to the CCSS patient portal, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to improving healthcare navigation for childhood cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual health insurance navigation program is safe?

Research shows that the Health Insurance Navigation Tools (HINT) program is practical and popular among childhood cancer survivors. Studies have found that participants accept this virtual program, with no reports of negative effects. It helps users understand and manage their health insurance better, reducing worries and unmet healthcare needs. As it is not a medical treatment, there are no physical safety concerns like those in drug trials. The program aims to improve long-term outcomes by increasing understanding of health insurance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Health Insurance Navigation Tools (HINT) program because it aims to simplify health insurance navigation for childhood cancer survivors, a group that can face complex health insurance challenges. Unlike current options that might not offer tailored support, the HINT program provides personalized guidance through two styles: a live, interactive version and a recorded, on-demand version. These interventions are designed to empower survivors with knowledge and confidence in managing their health insurance, potentially reducing stress and improving access to necessary care.

What evidence suggests that this trial's interventions could be effective for improving health insurance literacy in childhood cancer survivors?

Research has shown that tools designed to help understand health insurance benefit childhood cancer survivors. A small study found that these tools improve comprehension and use of health insurance, reducing worry and unmet health care needs. Childhood cancer survivors find the tools easy to use and favorable. In this trial, participants will use one of two versions of the tool: a live online version (HINT-S) or a recorded version (HINT-A), to determine which is more effective. ^{2 3 4 5 6}

Who Is on the Research Team?

Elyse R Park, Ph.D., MPH

Principal Investigator

MGH

Are You a Good Fit for This Trial?

This trial is for adults over 18 who survived childhood cancer. They must be able to consent, have US health insurance, internet access via a smart device, and be part of the LTFU cohort with access to the CCSS patient portal. Those from the pilot trial can't join.

Inclusion Criteria

Patients are able to give informed consent

Patients have US-based health insurance

Patients are current LTFU cohort participants

Exclusion Criteria

Participants from the pilot trial will not be eligible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the HINT-S synchronous or HINT-A asynchronous navigation intervention, or enhanced usual care

5 sessions

5 virtual sessions

Follow-up

Participants are monitored for changes in health insurance literacy, financial hardship, healthcare utilization, and out-of-pocket costs

12 months

Surveys at baseline, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Health Insurance Navigation Tools Program

Trial Overview

The study tests two programs: HINT-S (live sessions) and HINT-A (prerecorded), against enhanced usual care. It aims to see if these programs improve health insurance literacy, reduce worry about costs, meet healthcare needs better, and improve long-term outcomes.

How Is the Trial Designed?

Group I: HINT Synchronous Intervention Group (HINT-S) Experimental Treatment 1 Intervention

a virtual, synchronous version of the 5 HINT-S navigator sessions + HINT booklet

Group II: HINT Asynchronous Intervention Group (HINT-A) Experimental Treatment 1 Intervention

a prerecorded, asynchronous version of the 5 HINT-S navigator sessions + HINT booklet

Group III: Enhanced Usual Care Active Control 1 Intervention

HINT Booklet

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Childhood cancer survivors often struggle to obtain employer-sponsored health insurance (ESI), with many remaining uninsured and facing employment limitations that hinder their access to coverage.

While the Affordable Care Act (ACA) may help reduce some insurance barriers for these survivors, significant financial challenges remain, as many still cannot afford healthcare without employer support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Employer-sponsored health insurance coverage limitations: results from the Childhood Cancer Survivor Study. Kirchhoff, AC., Kuhlthau, K., Pajolek, H., et al.[2023]

Despite significant improvements in pediatric cancer outcomes, disparities exist in access to care and clinical trials, particularly for certain cancer types like brain tumors and sarcomas.

Ongoing advancements in understanding tumor biology and the need for multidisciplinary care are crucial for improving long-term outcomes and managing treatment-related toxicities in pediatric cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in Cancer Treatment of Children. Helms, L., Guimera, AE., Janeway, KA., et al.[2023]

Among 12,358 adult survivors of childhood cancer, only 83.9% had health insurance coverage compared to 88.3% of their sibling controls, indicating a significant disparity in coverage rates.

29% of childhood cancer survivors reported difficulties obtaining health insurance, highlighting the challenges faced by this population compared to only 3% of siblings, which raises concerns about their access to necessary healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health insurance coverage in survivors of childhood cancer: the Childhood Cancer Survivor Study. Park, ER., Li, FP., Liu, Y., et al.[2022]

About 23.7% of young adult cancer survivors and their parents registered for the ePHR, Cancer SurvivorLinkTM, and 38% of those registrants used it meaningfully, indicating a significant but selective engagement with the tool.

Young adult survivors transitioning to adult care were more likely to use the ePHR meaningfully, and using SurvivorLink was linked to a higher likelihood of attending annual follow-up visits, suggesting it may enhance care continuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaningful Use of an Electronic Personal Health Record (ePHR) among Pediatric Cancer Survivors. Williamson, RS., Cherven, BO., Gilleland Marchak, J., et al.[2018]

Digital health interventions are generally well-received by pediatric cancer survivors, providing benefits such as self-awareness, social connection, and empowerment, based on a systematic review of 16 qualitative studies.

However, users also face challenges related to program content, technology, and personal usage, highlighting the need for tailored interventions to enhance their effectiveness and user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pediatric Cancer Survivors' User Experiences With Digital Health Interventions: A Systematic Review of Qualitative Data. Cheng, L., Liu, F., Mao, X., et al.[2022]

Primary care physicians often lack knowledge about the specific health issues faced by adult survivors of childhood cancer, and many survivors are unaware of their own health risks.

To improve care, experts recommend a chronic disease management model, emphasizing targeted education for both primary care physicians and survivors, along with the creation of standardized survivorship care protocols and a national web-based information center.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving health care for adult survivors of childhood cancer: recommendations from a delphi panel of health policy experts. Mertens, AC., Cotter, KL., Foster, BM., et al.[2006]

Among childhood cancer survivors, non-Hispanic/Latinx Black individuals were significantly more likely to forgo needed medical care due to financial reasons compared to non-Hispanic/Latinx Whites, even after adjusting for factors like income and education.

Providing public insurance to all childhood cancer survivors could help reduce racial/ethnic disparities in accessing care, as those with public insurance had a low risk of forgoing care similar to that of privately insured non-Hispanic/Latinx Whites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Forgoing needed medical care among long-term survivors of childhood cancer: racial/ethnic-insurance disparities. Baedke, JL., Lindsey, LA., James, AS., et al.[2023]

Childhood cancer survivors often do not fully understand their health risks related to cancer treatment, with a survey of 528 participants showing many are unaware of late effects and less fearful of recurrence compared to their parents.

Web-based platforms like Passport for Care can significantly improve access to health information and awareness about late effects of cancer treatment, potentially enhancing adherence to follow-up care and facilitating further research on survivor health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Childhood Cancer Survivor Care Through Web-Based Platforms. Gramatges, MM., Bonaduce de Nigris, F., King, J., et al.[2018]

Children with cancer and childhood cancer survivors face significant barriers to healthcare, including high costs and inadequate insurance coverage, despite ongoing advocacy efforts.

The article reviews how the 2010 Patient Protection and Affordable Care Act addresses these challenges, aiming to improve access to care for these vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health care reform 2010: expected favorable impact on childhood cancer patients and survivors. Wolfson, J., Ruccione, K., Reaman, GH.[2010]

In a study of 459 pediatric cancer patients, those with Medicaid/Medicare insurance had significantly worse recurrence-free survival (RFS) and overall survival (OS) compared to those with private insurance, indicating a potential disparity in outcomes based on insurance type.

Patients with Medicaid/Medicare faced a 54% higher risk of cancer recurrence and a 79% higher risk of death compared to privately insured patients, highlighting the need for targeted interventions to support at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Health Insurance on Pediatric Cancer Survival: An Analysis of Children Evaluated for Radiation Therapy in Diverse Multicenter Health Systems. Fine, JR., Ransdell, JM., Pinheiro, PS., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11292596/

A Pilot Trial Within the Childhood Cancer Survivor Study - PMC

We report on the intervention development and randomized pilot trial results of a health insurance navigation tools (HINT) program. METHODS.

2.

ascopubs.org

ascopubs.org/doi/abs/10.1200/OP.23.00680

Health Insurance Navigation Tools Intervention: A Pilot ...

Childhood cancer survivors are at increased risk for underinsurance and health insurance–related financial burden.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05527392

NCT05527392 | Virtual Health Insurance Navigation Pilot ...

The present study seeks to evaluate a health insurance navigation program with childhood cancer survivors recruited from the Long-Term Follow-Up (LTFU) Cohort.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714425001466

Assessing the effect of virtual navigation interventions to ...

This trial will elucidate the potential effectiveness and implementation of health insurance navigation programs that may benefit many cancer survivors.

5.

massgeneral.org

massgeneral.org/news/research-spotlight/enhancing-health-insurance-literacy-in-childhood-cancer-survivors

Enhancing Health Insurance Literacy in Childhood Cancer ...

Results support the feasibility and acceptability of a virtual health insurance navigation program targeted for childhood survivors.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38471048/

A Pilot Trial Within the Childhood Cancer Survivor Study

Results support the feasibility and acceptability of a virtual health insurance navigation program targeted for childhood survivors to ...