Implementing Stepped Financial and Legal Navigation to Mitigate Financial Toxicity in Adolescent and Young Adult Cancer Patients - Adolescent and young adult (AYA) cancer patients suffer unparalleled financial toxicity (FT), with devastating effects to their physical and mental health and quality of life (QOL). Despite growing evidence on the positive impact of Oncology Financial and Legal Navigation (OFLN) on FT, health system implementation challenges preclude widespread adoption, particularly in community oncology practices. Alternative, resource-efficient approaches are needed to ensure adoption, sustainability and reach of OFLN tailored for AYAs. To address these implementation gaps, we propose a stepped OFLN which leverages risk-stratified, low-intensity (supported self-management using web-based educational resources) and high-intensity (virtual, navigator-led management) OFLN. The long-term goal of this research is to improve patient FT and QOL during cancer treatment. Our overall objective is to test the effectiveness and implementability of stepped OFLN in a randomized trial with hybrid type 1 (effectiveness-implementation) design. Our central hypothesis is that stepped OFLN is non-inferior to standard OFLN in terms of improving FT among AYA cancer patients and will demonstrate high acceptability, appropriateness, and feasibility. Tailoring the intensity of OFLN to the severity of FT helps maximize resource allocation while ensuring optimal patient outcomes and addresses scalability and uptake constraints, a critical consideration given the gap between OFLN demand and supply in community oncology practices, which provides a clear rationale for this study. The specific aims of this project are to determine if stepped OFLN is non-inferior to standard OFLN in improving: 1) patient reported outcomes (FT, cost-related health literacy, and psychological distress, i.e., depression, anxiety) and 2) implementation outcomes (acceptability, appropriateness, feasibility, and cost). We will also conduct a qualitative evaluation on implementation determinants and sustainability drivers that influence future adoption and scale up of OFLN. To accomplish these aims, 294 AYA patients undergoing treatment for cancer at the University of Louisville’s Brown Cancer Center will be randomized to stepped or standard OFLN, with outcomes collected at baseline and 12-, 30-, and 48-weeks. This research tests an innovative intervention, delivered at the point of cancer care, whose content, design, and implementation strategy are novel. The proposed research is highly significant both for its potential to mitigate the deleterious effects of FT for survivors and its disseminability into routine supportive care in both high- and low-resourced settings. Findings will inform a future hybrid 2 implementation-effectiveness randomized trial, which will refine implementation strategies to enhance the intervention’s widespread dissemination into real-world practice settings. Findings are responsive to NIH’s Unified Strategy Priorities by testing a solution-oriented approach to address FT in AYA cancer patients while also focuses on scientifically valid, measurable health outcomes.
