A registry-based randomised controlled trial (RRCT) of symptom monitoring, using patient-reported outcomes, and care coordination to improve quality of life for patients with upper gastrointestinal cancer.
To determine if symptom monitoring, using patient-reported outcomes (PROs), integrated into clinical practice in real-time, via care coordination, improves health outcomes for patients with pancreatic and oesophagogastric cancer in high-volume hospitals in Victoria.
Our primary objective is to assess whether the PROpatient intervention is effective in improving health-related quality of life (HRQoL) in patients diagnosed with pancreatic or oesophagogastric cancer.
Our secondary objectives are to assess whether, compared to usual practice, the PROpatient intervention positively impacts outcomes of patients diagnosed with UGI cancer. Specifically, we will assess whether patients assigned to the intervention arm demonstrate (at 3, 6 and 12 months);
- Reduced health service use and emergency department (ED) visits;
- Lower level of information needs;
- Timely referral to palliative care services;
- Increased median survival.
An economic evaluation will also be undertaken to assess cost-effectiveness of the intervention.
English-speaking patients newly diagnosed with pancreatic or oesophagogastric cancer, participating in the UGICR that are managed or treated at participating trial sites in Victoria, Australia.
An interventional, multicentre, registry-based randomised controlled trial (RRCT), leveraging the existing Upper Gastrointestinal Cancer Registry (UGICR), with two parallel groups.
The intervention arm will involve:
- Symptom reporting: collection of PROs to allow participants to track and report their symptoms over time;
- Symptom self-management: provision of real-time feedback to patients to aid in the management of their symptoms;
- Symptom monitoring & care coordination: alerts will be provided to the PROpatient Nurse Consultant (NC) after triaging of participants reporting severe or worsening symptoms to allow for follow-up of participants and, if necessary, connecting them with relevant site-specific health services and/or health professionals; and
- Clinician feedback: provision of real-time reports to clinicians.
The control arm will receive usual care.
The trial is planned to commence in January-March 2020, with a 20 month recruitment period, and is expected to be completed by December 2022.
Victorian Cancer Agency (VCA) Improving Cancer Outcomes for Upper Gastrointestinal Cancers Collaborative Research Grant (ICOUGI18008)
Australian New Zealand Clinical Trials Registry No: ACTRN12619001126101p
This project has received ethics approval from Monash Health HREC under the National Mutual Acceptance (NMA) scheme (55737).