Aims: The aim of PROpatient, a registry-based RCT, is to determine whether symptom monitoring, using patient-reported outcomes (PROs), integrated into clinical practice, via centralised care coordination, coupled with information support to participants, improves health-related quality of life (HRQL) for patients with pancreatic (PC) and oesophagogastric (OGC) cancers.
Methods: Eligible individuals with PC and OGC were recruited from the Upper Gastrointestinal Cancer Registry. Individuals were eligible if they were English speaking, diagnosed with PC or OGC and treated at one of the 12 participating health services in Victoria, Australia. In order to participate, individuals (or their carers) were required to have access to the internet and an IT device.
Participants were randomised to receive the PROpatient intervention or usual care over a 12-month period. The primary outcome of the trial was HRQL which was measured rom baseline to 6-months post-randomisation. Data from this trial was linked with clinical data and hospital administrative data sets for analysis.
Results: Between January 2021 and May 2023, 423 were eligible to participate in the trial. Of these, 198 (response rate of 47%) were recruited, with 100 in the control arm and 98 in the intervention arm. During the trial, 45 (23%) participants passed away during the 12-month trial period and three (1.5%) withdrew from the trial. Of those who were alive at 6-months, 168 (85%) completed the trial assessments. We tested the hypothesis that participants in the intervention arm of the trial will have improved HRQL at 6-months compared to those in the control arm (results imminent).
Conclusion: This innovative trial addresses a significant unmet need for individuals with PC and OGC. These cancers have a high symptom burden and dismal prognosis. It is critical that individuals with these cancers receive the best possible symptomatic control, while the search continues for treatments to improve survival.