Integration of precision medicine into routine cancer care—protocol for the Precision Care Initiative: a research programme of effectiveness-implementation hybrid trials

Introduction: Genomic diagnostics have accelerated therapeutic and preventative breakthroughs in oncology and cancer genetics. Despite increased access, the implementation of genomics-based care faces serious fragmentation and scalability issues due to a lack of system support. The Precision Care Initiative aims to develop a novel and scalable Precision Care Clinic (PCC). It is designed to coordinate precision medicine in oncology and streamline decision support for referring oncologists and geneticists. The PCC will enhance quality of care through multifaceted, patient-centred communication. It will also improve translational capacity by integrating team expertise in precision oncology, implementation science, clinical informatics, cancer genetics, health economics and patient-reported measures.

Methods and analysis:  This programme uses a type I and type II hybrid effectiveness-implementation trial design sequentially. The complex clinical intervention is precision oncology—matching the targeted treatment or risk management strategy to the right patient, based on their genomic, cancer staging, environmental, lifestyle and biological characteristics, etc. The service intervention is the PCC, providing centralised multidisciplinary review to facilitate shared decision-making with clinicians for the provision of optimal precision oncology care for their patients. The implementation intervention is the co-designed implementation platform—applying evidence-based implementation approaches and Learning Health System principles to enhance feasibility and sustainability. All adult patients across Australia referred to the PCC (n=est. 100–150/year), and healthcare professional interest holders involved in the delivery of precision oncology services, are eligible to participate. Over the study course, phase I involves using a mixed-methods approach to inform iterative co-design and pilot testing of the first PCC with an accompanying implementation platform, and a suite of outcome measures to assess effectiveness; phase II (hybrid type I) includes the implementation of the PCC and evaluation of the outcome measures designed in phase I; phase III (hybrid type II) involves a co-design of local adaptations and testing the effectiveness of the PCC model nationally.

Ethics and dissemination: The study received ethical approval from the St Vincent’s Hospital Human Research Ethics Committee (2023/ETH00373). Study results will be presented at relevant conferences and published in peer-reviewed journals.

Trial registration number NCT06077110