People with Cancer of Unknown Primary (CUP) have a poor prognosis and may undergo a protracted diagnostic workup causing patient distress and high cancer related costs. Not having a primary diagnosis limits timely site-specific treatment and access to precision medicine. There is a need to improve the diagnostic process, and healthcare delivery and support for these patients.
The SUPER-ED study is implementing and evaluating a new model of care across an existing network of oncology services for people presenting with suspected metastatic cancer without an obvious primary (malignancy of undefined primary origin, or MUO) to enable rapid, accurate diagnosis of either Cancer of Unknown Primary (CUP) or a known metastatic primary cancer; greater access to clinical studies/trials/appropriate management; improved experiential outcomes and reduced patient uncertainty and reduced healthcare costs.
Professor Linda Mileshkin is the clinical lead for the SUPER studies and works closely with Doctor Hui-li Wong (medical oncologist) and Associate Professor Richard Tothill (genomics lead) from the University of Melbourne.
SUPER-ED is recruiting patients from 15 metropolitan sites nationally in Victoria, New South Wales, Queensland, Northern Territory and Tasmania with a target recruitment of 240 participants.
Design
The SUPER-ED study is a pragmatic stepped-wedge cluster randomised trial comparing a control phase of standard practice with an intervention phase.
The intervention is a new model of care for patients with suspected or detected CUP, comprising four key components:
- Standardised diagnostic workup to guide the diagnosis, treatment and follow-up of patients, based on the CUP Australian Optimal Care Pathways.
- Dedicated cancer care coordinators will be embedded within local oncology clinics for the assessment and coordination of MUO/CUP patients’ clinical and supportive care needs.
- Virtual, second opinion multidisciplinary meetings (MDMs) will bring together national experts to deliver quality care recommendations for MUO/CUP patients; including representation from medical oncology, pathology and imaging.
- Website resource for patients, carers and clinicians will provide comprehensive information on the diagnosis and treatment of MUO/CUP, including filmed interviews, clinical trials and the latest research.
Eligibility Criteria
Patient inclusion criteria are aged 18 years or older, presenting with malignancy of undefined primary origin (i.e., suspected metastatic malignancy without an obvious primary site on imaging), clinically appropriate to undergo diagnostic work-up as determined by the treating clinician and able to provide written or verbal consent.
Primary Objectives of SUPER-ED
This trial aims to implement and evaluate a new model of care for people with MUO to reduce time to diagnosis, improve patient experiences and reduce healthcare costs. The new model of care consists of a) standardised diagnostic workup, b) a national virtual multidisciplinary meeting of clinical experts in cancer of unknown primary, c) embedded and dedicated cancer care coordinators and d) an educational website providing information for patients, carers and clinicians.
The specific aims are to:
- understand the impact of the model of care on patient diagnostic workup, patient experience and healthcare costs;
- evaluate the implementation of the model of care.
Study Overview
Sponsor
Peter MacCallum Cancer Centre
Funding
SUPER-ED is funded by the MRFF (Medical Research Future Fund) Emerging Priorities and Consumer-Doctoriven Research Initiative Grant.
Principal Investigators
Principal Investigator
Chief Investigators
- Associate Professor Anna Ugalde
- Associate Professor Richard Tothill
- Associate Professor Steve Quinn
- Doctor Hui-li Wong
- Doctor Catherine Mitchell
- Professor Nilmini Wickramasinghe
- Doctor Clare Fedele
Contact details
Research Project Manager - Natalie Richards
Email:
Project status
Not yet recruiting
Related pages
- Cancer of Unknown Primary (CUP) information for health professionals
- Cancer of Unknown Primary (CUP)