R01CA271380

Assessing the Effect of Virtual Navigation Interventions to Improve Health Insurance Literacy and Decrease Financial Burden: A CCSS Randomized Trial

Childhood cancer survivors often have complex health needs that require medical surveillance, requiring them to navigate the complexities of the health care system. Despite the Affordable Care Act's expansion of insurance, many childhood cancer survivors continue to experience underinsurance and barriers to care. Adequate health insurance literacy is a key skill for survivors to obtain and utilize health insurance and to prevent high out-of-pocket costs or unmet health care needs.

Interventions are critically needed to support childhood cancer survivors in addressing issues of insurance, but to date no intervention has been developed to improve childhood survivors' health insurance literacy. Guided by Andersen and Aday's Behavioral Model of Health Services Use, we developed a patient navigation intervention and health insurance booklet, targeted for survivors. We conducted a pilot randomized trial comparing intervention, health insurance navigation tools (HINT-S), delivered synchronously via Zoom, to enhanced usual care (EUC; digital health insurance booklet only) among 82 survivors in the Childhood Cancer Survivor Study (CCSS) cohort. HINT-S incorporates a strong psychoeducational component, with 4 45-minute sessions designed to improve survivors' conceptual knowledge of health insurance and cost. Preliminary results support its feasibility, acceptability, and preliminary efficacy.

In response to RFA-CA-20-027, we propose a Type 1 hybrid effectiveness-implementation trial to test HINT-S vs. EUC to promote health insurance literacy, as well as improving downstream financial hardship and health care. We will randomize 520 survivors from the CCSS cohort to: HINT-S, HINT-A (4 prerecorded, asynchronous navigator sessions, which has the potential to be cost-effective and scalable), and EUC. All study activities, including recruitment, data collection, and navigation, will be conducted virtually, via the CCSS mHealth platform and patient portal.

We will investigate whether HINT-S improves health insurance literacy over EUC at 6 months (primary outcome) and explore the relative difference in effect size and cost of HINT-S compared to HINT-A. We will explore moderators (e.g., sociodemographics, insurance status, state Medicaid expansion status, cancer and health history, and baseline literacy) of the intervention effects. The association of health insurance literacy with longer-term outcomes, such as financial hardship (worry, unmet healthcare needs, and financial consequences of medical costs), decreases in out-of-pocket costs, and improvements in healthcare utilization at 18 months will be investigated. Implementation evaluation will assess the intervention's reach, engagement, acceptability, fidelity, and sustainability (including cost).

This study is innovative for the 1) comparison of digital intervention delivery, 2) focus on health insurance literacy, and 3) access to a national sample of long-term childhood cancer survivors. Digitally-delivered interventions that address health insurance literacy can lead to national sustainable improvements in childhood survivors' health care costs and care.

The General Hospital Corporation

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

Boston, Massachusetts 021142518 United States

Single Zip Code

Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors (R01 Clinical Trial Optional) (RFA-CA-20-027)

Amendment Since initial award the total obligations have increased 345% from $689,962 to $3,070,648.