Ugalde, Anna

Tothill, Richard W

Quinn, Stephen

Wong, Hui-Li

Prall, Owen

Mitchell, Catherine

Wickramasinghe, Nilmini

Fedele, Clare

Richards, Natalie

Todio, Elizabeth

Bryant, Cindy

Collins, Louisa G

McLean, Sarah

Ko, Hyun Soo

Akhurst, Tim

Steer, Christopher

Gao, Bo

Wong, Mark

Georgiou, Chloe

Karanth, Narayan

Kuchel, Anna

Nott, Louise

Padinharakam, Shamsudheen

Shackleton, Mark

Collins, Ian M

Singh, Madhu

Wong, Rachel

Wong, Zee Wan

Butler, Alexis

Sivakumaran, Tharani

Schofield, Penelope

Mileshkin, Linda

2025-01-29

People with malignancy of undefined primary origin (MUO) 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. This trial aims to implement and evaluate an optimal model of care for people presenting with MUO to reduce time to diagnosis, improve patient experiences and reduce healthcare costs.This is a pragmatic stepped-wedge cluster randomised trial comparing a control phase of standard practice with an intervention phase. Patient inclusion criteria are: 1) age 18 years or older, 2) presenting with suspected metastatic malignancy without an obvious primary site on imaging, 3) clinically appropriate to undergo diagnostic work-up and 4) able to provide written or verbal consent. The intervention is a new model of care comprising four key components: standardised diagnostic workup, dedicated cancer care coordinators, virtual multidisciplinary meetings and a website resource for patients, carers and clinicians. The primary endpoint is the time to completion of minimum diagnostic workup. Secondary outcomes are whether the type of tumour is diagnosed, clinical trial participation, referral to palliative care, patient-reported physical, social and mental health, patient-reported understanding and uncertainty. Implementation outcomes include acceptability, feasibility, fidelity and adoption and health care use and costs. Intervention implementation will be supported using clinical leadership, education and reinforcement. Patients who consent to having their data collected will receive the model of care active at the site at the time of recruitment. Patients will complete a patient-reported outcomes questionnaire four months after study enrolment. A health economic analysis will be included. Across 15 hospitals, a total sample size of 240 is planned.There is a lack of intervention research for people presenting with MUO. The stepped-wedge design seeks to mitigate the potential challenge of enrolling people with a poor prognosis and high symptom burden in trials. This research will generate important evidence with scalability for future research at trial completion.ACTRN12622001504707.

Institute for Health Transformation, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, Geelong, Victoria, 3125, Australia. a.ugalde@deakin.edu.au.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Victoria, Australia.

Department of Clinical Pathology and Centre for Cancer Research, University of Melbourne, Parkville, Victoria, Australia.

Swinburne University of Technology, Hawthorn, Victoria, Australia.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Victoria, Australia.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Victoria, Australia.

Swinburne University of Technology, Hawthorn, Victoria, Australia.

Latrobe University, Bundoora, Victoria, Australia.

CSL Innovation, Melbourne, Victoria, Australia.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Swinburne University of Technology, Hawthorn, Victoria, Australia.

Swinburne University of Technology, Hawthorn, Victoria, Australia.

QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.

Viertel Cancer Research Centre, Cancer Council Queensland, Queensland, Australia.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Victoria, Australia.

Department of Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Australia.

Department of Diagnostic and interventional Radiology, University Hospital Bonn, Bonn, Germany.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Border Medical Oncology, Albury Wodonga Regional Cancer Centre, Albury, New South Wales, Australia.

University of Sydney, Sydney, New South Wales, Australia.

Department of Medical Oncology, Westmead Hospital, Sydney, New South Wales, Australia.

Department of Medical Oncology, Westmead Hospital, Sydney, New South Wales, Australia.

Department of Medical Oncology, Bendigo Health, Bendigo, Victoria, Australia.

Department of Medical Oncology, Royal Darwin Hospital, Darwin, Northern Territory, Australia.

University of Queensland, Brisbane, Queensland, Australia.

Department of Medical Oncology, Royal Hobart Hospital, Hobart, Tasmania, Australia.

Launceston General Hospital, Launceston, Tasmania, Australia.

Department of Oncology, Alfred Hospital, Melbourne, Victoria, Australia.

School of Translational Medicine, Monash University, Melbourne, Victoria, Australia.

Institute for Health Transformation, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, Geelong, Victoria, 3125, Australia.

Southwest Healthcare, Warrnambool, Victoria, Australia.

Barwon Health, Geelong, Victoria, Australia.

Eastern Health, Melbourne, Victoria, Australia.

Monash Health, Clayton, Victoria, Australia.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Victoria, Australia.

Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Victoria, Australia.

Swinburne University of Technology, Hawthorn, Victoria, Australia.

School of Computing, Engineering and Mathematical Sciences, La Trobe University, Melbourne, Australia.

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.

Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Victoria, Australia.

BMC Cancer . 2025 Jan 29;25(1):171. doi: 10.1186/s12885-025-13506-4.

1471-2407

https://pubmed.ncbi.nlm.nih.gov/39881222/?otool=iaurydwlib

https://hdl.handle.net/10137/13955

Cancer

Care

Diagnosis

Stepped-wedge cluster

Support

Unknown primary cancer

Humans

Neoplasms, Unknown Primary

Early Detection of Cancer

Female

Quality of Life

Male

Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin.

Journal Article

Publication