NCT06976710: PC2

PRIORITY-CONNECT 2 Trial

Recruiting now NA Last updated 22 January 2026

What this trial tests

NA trial testing Preoperative Exercise in Colorectal Cancer in 564 participants. Currently enrolling.

Timeline

15 October 2025

Primary endpoint
30 July 2028

30 July 2028

Quick facts

Lead sponsor	Surgical Outcomes Research Centre (SOuRCe)
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	564
Start date	15 October 2025
Primary completion	30 July 2028
Estimated completion	30 July 2028
Sites	31 locations across Australia

Drugs / interventions tested

• Preoperative Exercise
• Postoperative Exercise
• Preoperative Nutrition
• Postoperative Nutrition
• Preoperative Psychology
• Postoperative Psychology
• Preoperative Nursing
• Postoperative Nursing
• Preoperative Peer Support Group
• Postoperative Peer Support Group
• Usual Care

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Colorectal Neoplasms — all drugs for Colorectal Neoplasms →

Sponsor

Surgical Outcomes Research Centre (SOuRCe)

Who can join

18 and older, any sex, with Colorectal Cancer or Colorectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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, subtotal colectomy, total colectomy) at sites throughout Australia will be included. These are common colorectal cancer surgeries performed at the participating centres. All the surgeons involved in this study have clinical appointments in their respective hospitals.

Inclusion: Adults aged ≥18 years undergoing elective major surgery for colon or rectal cancer with curative intent; and consulting a colorectal surgeon at least 1 week prior to scheduled surgery.

Exclusion: Patients undergoing Pelvic Exenteration (PE), Cytoreductive Surgery (CRS) with or without HIPEC, or concurrent surgery for metastatic disease; or cognitive impairment such that they are unable to provide informed consent.

Study Procedure:

Participant's treating team will screen and provide an information sheet about the trial to consecutive patients. Interested patients will be contacted by a study researcher to discuss the trial further, answer any questions, confirm eligibility against the inclusion and exclusion criteria, and consent patients. Consenting patients will undergo baseline assessment and be randomised to a virtual multimodal hub (Intervention group) or usual care alone (Control group). The intervention will include the delivery of usual care and evidence-based exercise, nutritional, psychological and nursing interventions, and / or group-delivered peer support. All interventions will be conducted before and after surgery.

Duration of the Study:

Approximately 60 months.

Funding:

Medical Research Future Fund (MRFF) 2023 Early and Mid-Career Researchers (Application ID: 2031563).

Sponsor:

The University of Sydney.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.