Upper Gastrointestinal Cancer Care Coordination (UGICCC) Project: a protocol for a registry-based randomised control trial of symptom monitoring, using patient-reported outcomes, and care coordination integrated into clinical practice.

Abstract

Aims: Background: Upper gastrointestinal (UGI) cancers (pancreatic, oesophageal and stomach) have a dismal prognosis, with five-year survival of only 7.7-28.5% even when detected in their early stages and treated with a complete resection. UGI cancers are characterised by a high symptom burden. It is critical that patients with these cancers receive the best possible symptomatic control, while the search continues for treatments to improve survival. Recent research has shown that patient-reported outcomes (PROs), integrated into clinical practice in a meaningful way to drive action, are associated with improved patient health outcomes and decrease burden to the healthcare system. Aim(s): To determine whether the systematic measurement, identification and management of PROs in clinical practice, coupled with information support to patients, improves health outcomes for patients with UGI cancers. Methods and Design: A registry-based randomised, multicentre, controlled trial will be designed to assess whether, compared to usual practice, the UGI Cancer Care Coordination (UGICCC) intervention is effective in improving health-related quality of life in patients diagnosed with UGI cancers, as the primary outcome. The UGICCC intervention involves: (1) collection of PROs to allow patients to track and report their symptoms over time; (2) provision of real-time feedback to patients for management of symptoms; and (3) alerts to a care-coordinator of patients reporting severe or worsening symptoms to allow for triage and follow-up as well as provision of real-time reports to clinicians. The secondary outcome measures are to assess whether patients assigned to the intervention arm demonstrate: reduced health service use and emergency department visits; lower level of information needs; timely referral to palliative care services; and increased median survival. These will be evaluated at baseline, 3-, 6- and 12-months. Participants will be recruited from eight hospitals in Victoria, Australia, with high volumes of UGI cancer cases (including one regional and one private site), and stratified by site and disease. Result(s): Conclusion(s): Ethics and dissemination: Ethics approval will be obtained for all participating sites. Result(s): of the trial, and secondary outcomes, will be submitted for publication in a peer-reviewed journal and findings will be linked with the Upper Gastrointestinal Cancer Registry.