Condition: Colorectal Cancer · Colorectal Neoplasms · Sponsor: Surgical Outcomes Research Centre (SOuRCe)
Objectives: The primary aim of this project is to establish the effectiveness of an individualised stepped, multidisciplinary intervention, including education and peer support group, delivered via a virtual multimodal (p)rehabilitation hub, in reducing postoperative complications within 30-days following colorectal cancer surgery, compared to usual care alone. The secondary aims will be to obtain data on the likely difference in key outcomes including: (i) Quality of life (EORTC QLQ-C30 and QLQ-CR29) (ii) Number of days at home within 30, 90 and 365 days after surgery (DAH-30, 90, 365) (iii) Quality of recovery (QoR-15) (iv) Cost-effectiveness (v) Implementation metrics (RE-AIM) Our hypothesis is that the PRIORITY-CONNECT 2 intervention will be more effective in reducing postoperative complications and more cost-effective than usual care. Study design: Pragmatic Randomised Type I Hybrid Effectiveness-Implementation Trial. Planned sample size: To achieve the primary aim, 564 participants will provide 90% power to detect a 15% difference in 30-day postoperative complication rates between the intervention and control groups. The sample size calculation accounts for up to 10% loss to follow-up, 5% non-compliance and a two-side alpha of 0.05. Selection criteria: A sample of 564 participants undergoing colorectal cancer surgery including open, laparoscopic or robotic-assisted surgery (mostly, anterior resection, sigmoid colectomy, hemicolectomy, total proctocolectomy, su…
This description comes directly from the study's public registry record.
Daniel Steffens, PhD · +61 02 9515 3203 · Daniel.Steffens@health.nsw.gov.au
Always discuss trial participation with your own doctor first.
| Coffs Harbour Health Campus | Coffs Harbour, New South Wales, Australia | Recruiting |
| Calvary Mater Hospital | Newcastle, New South Wales, Australia | Not Yet Recruiting |
| John Hunter Hospital | Newcastle, New South Wales, Australia | Not Yet Recruiting |
| Chris O'Brien Lifehouse | Sydney, New South Wales, Australia | Recruiting |
| Royal Prince Alfred Hospital | Sydney, New South Wales, Australia | Recruiting |
| Concord Repatriation General Hospital | Sydney, New South Wales, Australia | Not Yet Recruiting |
| Westmead Hospital | Sydney, New South Wales, Australia | Not Yet Recruiting |
| Blacktown Hospital | Sydney, New South Wales, Australia | Not Yet Recruiting |
| Wagga Wagga Base Hospital | Wagga Wagga, New South Wales, Australia | Not Yet Recruiting |
| Wollongong Hospital | Wollongong, New South Wales, Australia | Not Yet Recruiting |
| Royal Brisbane & Women's Hospital | Brisbane, Queensland, Australia | Recruiting |
| Princess Alexandra Hospital | Brisbane, Queensland, Australia | Not Yet Recruiting |
+ 19 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06976710