Background:Equitable access to early-phase oncology clinical trials remains challenging for patients living outside metropolitan centres due to financial, logistical and frequent visit demands. These factors contribute to time toxicity, defined as the time patients spend travelling to, waiting for, and receiving healthcare, an increasingly recognised patient-centred outcome in oncology. Decentralised clinical trial (DCT) models may reduce time toxicity by enabling selected trial activities closer to participants' homes and have demonstrated operational feasibility through The Kinghorn Cancer Centre's Phase I 4CAST trial. However, further evaluation is needed to understand the economic and participant-centred consequences of decentralised trial delivery, including impacts on travel, personal financial costs and healthcare utilisation.
Aim: To evaluate the costs and consequences of DCT delivery in a pilot cohort enrolled in an early-phase oncology clinical trial with decentralised components.
Methods:A pilot cost-consequence analysis will be undertaken using participant-level data from the 4CAST DCT program at The Kinghorn Cancer Centre. Additional costs and savings associated with decentralisation compared with conventional site-based trial delivery will be estimated. Data collected will include travel distance, travel time, out-of-pocket expenses and trial-related healthcare utilisation. Time toxicity, travel burden, access to care and personal costs will be evaluated by comparing decentralised and conventional trial activities. Results will be reported descriptively across disaggregated cost and consequence domains. This pilot study has received HREC approval.
Expected outcomes:This study will provide insight into the economic and participant-centred consequences of DCT delivery in early-phase oncology. Expected outcomes include quantification of travel and time savings, reduced participant financial burden, improved understanding of resources required for DCT implementation, and evidence to inform future economic evaluations. Findings will support the potential for DCT models to improve equitable access to clinical trials for regional, rural and remote populations and guide broader implementation across Australian early phase trial networks nationally