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

Addressing Unknown Primary Cancer with Early Diagnosis — The SUPER-ED Trial

Background

Patients with malignancy of undefined origin (MUO) face serious challenges, including poor outcomes and lengthy diagnostic processes. This often leads to patient distress and increased healthcare costs. Without a known primary diagnosis, timely treatment is delayed. Our goal is to enhance the diagnostic process and provide better support for these patients.

Trial Overview

This trial compares standard care with a new care model designed to:

  • Reduce the time to diagnosis
  • Improve patient experiences
  • Lower healthcare costs

Methods

The trial involves patients aged 18 and older who have suspected metastatic cancer without a clear primary site. Key features of the new model include:

  • Standardized diagnostic procedures
  • Dedicated cancer care coordinators
  • Virtual multidisciplinary meetings
  • A resource website for patients and clinicians

The primary goal is to speed up the diagnostic process. We will also measure the diagnosis of tumor types, participation in clinical trials, referrals to palliative care, and patient-reported health outcomes.

Implementation

Successful implementation will involve clinical leadership, education, and support. Patients will be monitored for four months, and a health economic analysis will be conducted. The trial will include 240 participants across 15 hospitals.

Significance

This research addresses a gap in interventions for MUO patients. The stepped-wedge design aims to make it easier to enroll patients with severe symptoms, ensuring their participation is meaningful and manageable.

Trial Registration

Registered under ACTRN12622001504707.

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