Introduction
The PRIORITY trial is a multi-centre randomised control trial currently in the recruitment and data collection phase. The trial is focusing on optimising patients’ recovery after undergoing radical gastrointestinal cancer surgeries through prehabilitation. It aims to study the effectiveness of a progressive, individualised preoperative exercise and education program compared to usual care in reducing the proportion of patients who experience postoperative in-hospital complications. Secondarily, it aims to investigate whether the exercise and education program reduces intensive care and hospital length of stay, improves quality of life outcomes, and is more cost-effective than usual care as a result.
Methods
The trial will recruit a desired sample of at least 172 participants from the Royal Prince Alfred Hospital and Chris O’Brien Lifehouse, Sydney, and Peter MacCallum Cancer Centre, Melbourne. Participants will be adults aged 18 to 80 years and undergoing Pelvic Exenteration, Cytoreduction, Oesophagectomy, Pancreatectomy, Hepatectomy, or Gastrectomy surgery for cancer. After providing consent and completing a baseline assessment, patients will be randomised into either the preoperative exercise and education program (Intervention) or usual care (Control) group using a permuted block randomisation with 1:1 allocation.
Participants will be followed up until 3 months after their operation (Figure 1). The intervention group will complete a preoperative exercise and education program for 4 - 8 weeks before undergoing scheduled surgery. This program will be conducted by local physiotherapists or exercise physiologists close to the patients’ homes. The control group will complete the usual care provided by the treating team, consisting of nutritional counselling and advice on smoking cessation and reduction of alcohol (Figure 2). Data will be collected from electronic medical records and participant self-completed assessments.
Results
Participant recruitment commenced in June 2021, and 133 patients have been recruited thus far. These include 62 (47%) females and 71 (53%) men, with an average age of 59. 71 (53%) patients underwent Cytoreduction surgery, 29 (22%) Pelvic Exenteration, and 33 (25%) procedures for Upper GI cancer. Data analysis will be conducted once the recruitment target has been reached and all participants have completed the final assessment. Analysis will be done by an independent, blinded biostatistician, and focus on evaluating the primary and secondary outcomes.
Conclusion
If successful, the preoperative exercise and education intervention would improve patient outcomes and substantially reduce health care costs.