Development of an eHealth tool for capturing and analyzing the immune-related adverse events (irAEs) in cancer treatment.
Published on: October 04, 2023
Original author: Moradian S, et al. (2023) (DOI: 10.1177/11769351231178587)
Immunotherapy is rapidly advancing and can now be considered a powerful new tool in the treatment of cancer. However, it is associated with a myriad of Immune-related adverse events (irAEs). These irAEs can affect numerous body organs and are potentially life-threatening if not promptly recognized and treated. Therefore, early recognition and effective management of these irAEs are critical to reduce the treatment sequelae. Patients are often required to monitor and manage a range of potentially diverse and complicated irAEs without readily available clinical support and report poor quality of self-management support in ambulatory cancer care. This sub-optimal irAEs management has resulted in high rates of cancer symptom severity and avoidable emergency department visits and hospitalization. mHealth technologies are emerging as a solution to this problem. Additionally, adapted the system’s risk-scoring and decision-support algorithms to align with Canadian evidence-based protocols for symptom triage. Building on this foundation, developed V-Care, an eHealth platform comprising an electronic patient-reported outcome (ePRO) for a new follow-up pathway for cancer patients receiving immune checkpoint inhibitors (ICIs). Although immunotherapy is associated with unique irAEs that are more unpredictable than chemotherapy adverse events (AEs), early detection and relevant treatment initiation can manage most of these side effects. Methodology: The team co-developed a digital platform (V-Care) using ePROs to create a new follow-up pathway for cancer patients receiving immunotherapy. To operationalize the first 3 phases of the CeHRes roadmap, they employed multiple methods that were integrated throughout the development process, rather than being performed in a linear fashion. The teams employed an agile approach in a dynamic and iterative manner, engaging key stakeholders throughout the process. Development of the V-Care is reported according to the British Medical Research Council (MRC) guideline for the development of complex interventions that describes the whole process from development to implementation. In the process of developing and evaluating a complex intervention, the MRC guidance includes 4 phases: development, feasibility and piloting, and evaluation and implementation. Additionally, the Center for eHealth Research and Disease Management (CeHRes) roadmap for the development of eHealth technologies was utilized, which comprises distinct development phases ranging from contextual inquiry to operationalization. A multi-disciplinary team played a pivotal role in the successful design and development of the V-Care platform. This diverse team, comprised of researchers, oncology clinicians, digital health experts, computer scientists, and patient advocates, exemplified the power of collaboration in overcoming challenges and creating a robust, user-centric system. In the multidisciplinary collaboration to develop V-Care, clinicians also played a vital role by providing their expertise and perspective on the tool’s development. As key stakeholders, they were consulted throughout the process to offer input on the objectives and strategies necessary to address the identified needs. Their practical experience and understanding of patient care allowed the team to develop a more comprehensive and effective solution tailored to the realities of clinical practice. Results: The development of the application was categorized into 2 phases: “user interface” (UI) and “user experience” (UX) designs. In the first phase, the pages of the application were segmented into general categories, and feedback from all stakeholders was received and used to modify the application. In phase 2, mock-up pages were developed and sent to the Figma website. Moreover, the Android Package Kit (APK) of the application was installed and tested multiple times on a mobile phone to proactively detect and fix any errors. After resolving some technical issues and adjusting errors on the Android version to improve the user experience, the iOS version of the application was developed. The V-Care platform aims to bridge the gap in existing ePRO systems by focusing on the unique challenges faced by cancer patients receiving immunotherapy. The platform’s goal was to improve patient outcomes, reduce healthcare system costs, and promote a more collaborative and personalized approach to cancer care. By providing patients with access to tailored self-care advice and facilitating prompt medical interventions when needed, V-Care has the potential to revolutionize the management of irAEs and improve the quality of life for cancer patients undergoing ICIs treatments. Conclusion: The V-Care platform can be used to investigate the reported symptoms experienced by cancer patients receiving Immune checkpoint inhibitors (ICIs) and to compare them with the results from the clinical trials. Furthermore, the project may utilize ePRO tools to collect symptoms from patients and provide insight into whether the reported symptoms are linked to the treatment. Impact of the Research: 1. V-Care provides a secure, easy-to-use interface for patient-clinician communication and data exchange. 2. New follow-up pathway for cancer patients receiving immunotherapy. 3. Identification of Myriad of Immune-related adverse events (irAEs), which affect numerous body organs and are potentially life-threatening.