Planning for Scale-Up and Sustainability: A Multi-site Process Evaluation Protocol for a Novel Intervention for Survivors of Childhood Brain Cancer

Abstract Complex interventions often fail to sustain widespread reach at a population level, despite demonstrating clinical effectiveness during piloting and trial evaluation. ‘Engage’ is a multi-disciplinary and risk-stratified intervention that is delivered remotely to childhood cancer survivors to promote equitable and improved access to survivorship care. Engage is not a standalone intervention in that it requires careful consideration of how it will be integrated into existing survivorship care pathways. Our study aims to conduct a process evaluation of the Engage intervention as applied to brain cancer survivors (‘Engage Brain’) to further contextualise trial outcomes, and understand what factors contribute to a sustainable, scalable, and successfully implementable intervention. A mixed-methods process evaluation will be conducted as part of the Engage Brain type-1 effectiveness-implementation trial. Data collection will occur across four domains of research: (1) planning, (2) implementation, (3) practice setting, and (4) ecological setting. Data sources will include semi-structured clinical stakeholder interviews, primary care practitioner interviews, transcribed implementation meetings and project log, transcribed nurse consultations, study materials, and administrative/process data. Qualitative data will be analysed using both deductive and inductive thematic analysis, guided by implementation science frameworks such as the updated Consolidated Framework for Implementation Research, which encompasses the Theoretical Domains Framework and implementation outcomes. Quantitative data will be analysed and presented using descriptive statistics where appropriate. Conducting a process evaluation underpinned by implementation science and behaviour change theories will enable the development of a national scale-up framework and improved delivery of sustainable models of care for childhood cancer survivors. Trial Registration: The Australian and New Zealand Clinical Trials Registry (ANZCTR), https://www.anzctr.org.au , ACTRN12621000590864.