Solving unknown primary cancer - Earlier diagnosis (SUPER-ED): A stepped wedge cluster randomised controlled trial implementing a Model of Care to support earlier diagnosis

Abstract

Background and Aims: Cancer of unknown primary encompasses a diverse range of cancer types, whereby a metastatic lesion(s) is identified but a primary tumour evades clinical detection. Not all patients with cancer of unknown primary in Australia receive a standardised workup and this may lead to prolonged time to diagnosis and poor patient experience. This trial, titled Solving Unknown Primary Cancer - Earlier Diagnosis (SUPER-ED), aims to (1) standardise aModel of Care that adopts a standardised diagnostic workup adapted from the Optimal Care Pathways, with an embedded care coordinator, access to a virtual, national multidisciplinary meeting and an educational website and (2) implement this newModel of Care across a network of oncology services. This trial is funded from theMedical Research Future Fund. Method(s): This is a stepped-wedge cluster randomised trial comparing a control phase (standard practice) with an intervention phase. Fifteen sites will be grouped into three health service clusters. People who presentwith a malignancy of unknown origin, are over 18, are clinically appropriate to undergo diagnostic workup and able to consent will be eligible to participate. A total of 288 patients will be enrolled. The intervention is the new Model of Care and the primary endpoint is the time to completion of minimum diagnostic workup. Secondary endpoints include: the primary tumour type diagnosed, clinical trial participation rates, patient-reported physical, social and mental health, uncertainty and understanding. The implementation of the Model of Care will be assessed for acceptability, adoption, feasibility and fidelity through semi-structured clinician interviews, engagement with the nurse coordinator, diagnostic workup and website analytics.