Solving Unknown Primary cancER Earlier Diagnosis (SUPER-ED): A stepped wedge cluster randomised controlled trial implementing a Model of Care to support earlier diagnosis

Fifteen participating sites from our existing network of Cancer of Unknown Primary (CUP) collaborating sites will be randomised into one of the three clusters, with 5 sites per group. Each site will commence receiving the intervention at the time corresponding to their randomised cluster. Each period corresponds to 6 months, with a one-month changeover period between Control and Intervention. Components of the intervention include: - Patient access to a dedicated CUP care coordinator who will provide support and care relating to the patient’s CUP diagnosis. Interaction with the CUP care coordinator will be consistent with care coordination in usual care. There may be occasional interaction remotely if necessary though it is expected that the majority of interactions are face to face. - Patient access to the SUPER-ED CUP website which will include educational material and resources relating to their CUP diagnosis. Participants will not be asked to spend a minimum amount of time interacting with the SUPER-ED CUP website. Use of the website will be at their discretion. - Participants will undergo a standardised diagnostic workup including a minimum diagnostic work up (e.g. physical examinations, blood tests, medical imaging scans, biopsy) - If applicable to the patient’s case, additional investigations may be performed including site- or subtype-directed investigations based on the specific presentation (e.g. molecular testing) - Fortnightly virtual multidisciplinary meetings (MDM) will be hosted and coordinated by the Peter MacCallum Cancer Centre’s specialist CUP service to provide expert opinion on the diagnosis or management of challenging, complex or interesting cases. Patient participants will not attend the virtual MDMs, consistent with MDMs in usual practice. It is anticipated the MDMs will run on a fortnightly basis for one hour. Being a stepped wedge trial, all components of the intervention will be made available to participants upon enrolment. Each component will be the usual care delivered at that site, and will be delivered by the oncology team including the nurse coordinator. There are no anticipated time periods for each step of the intervention, rather, the intervention becomes the current model of care. Strategies to monitor adherence to the intervention will not be utilised. The CUP care coordinator role is patient-facing and will encompass: a) Assessing patients’ clinical and supportive care needs b) Providing information and education about their cancer c) Planning and coordinating clinical care (e.g. ordering tests, specialist appointments, clinic visits) d) Referring to other services (social work, pastoral care etc) e) Providing counselling f) Delivering clinical care g) Working within the local oncology clinics and MDM settings h) Supporting access to the SUPER-ED website i) Facilitating discussion of cases at the virtual CUP MDM. No additional training will be required for the local CUP care coordinators. The CUP website has been designed specifically for the SUPER-ED study, however the content is based on the Optimal Care Pathway (OCP) for people with cancer of unknown primary. This OCP is endorsed by a panel of experts and jurisdictional and consumer representatives that was established by the Council of Australian Governments. A wide range of clinicians, peak health organisations, consumers and carers were consulted or participated in their development. https://www.cancer.org.au/assets/pdf/cancer-of-unknown-primary-january-2020 The CUP website will include: (a) CUP Optimal Care Pathway: Links to the CUP OCP, including explanations of medical/scientific terms and understanding the diagnostic process. (b) Current clinical trials: A complete and regularly updated list of all Australian currently recruiting clinical trials for CUP will be maintained. These will include (but not be limited to) the SUPER suite of trials and other treatment trials that deliver therapeutics on the basis of actionable molecular targets. (c) Clinician’s corner: Videos of Australia’s leading CUP clinicians, pathologist and molecular biologists will provide comprehensible information on state-of-the-art diagnostic, treatment and management information for CUP to upskill clinicians (and consumers) in diagnosis and disease management. Recordings of the virtual MDMs tackling challenging cases will be included here for viewing by the patient, carers and their treatment team in a password protected area. (d) Understanding CUP: Individual videos of patients and carers talking about their real-world experience of living with CUP covering: understanding of the diagnostic process, experimental diagnostic molecular tests, treatment and care experiences, uncertainty and other emotions. (e) Consultation help for patients: Printable versions of recommended diagnostic tests drawn from the CUP OCP and question prompt lists for patients to take to their next clinician consultation to guide discussion. (f) More information: Links to trustworthy external resources, including other patient information and support via the Cancer Council (such as the Cancer Information and Support Service 131120); CUP Foundation UK, and other reputable evidence-based websites.