PRIORITY-CONNECT 2 Trial

Summary

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.

Conditions

• Colorectal Cancer
• Colorectal Neoplasms

Interventions

OTHER

Usual Care

All participants will receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling, and medical optimisation in the preoperative anaesthetic clinic visits.

BEHAVIORAL

Preoperative Exercise

Aerobic, Endurance, Respiratory, Muscle Strength, Education

BEHAVIORAL

Postoperative Exercise

Aerobic, Endurance, Respiratory, Muscle Strength, Education

DIETARY_SUPPLEMENT

Preoperative Nutrition

Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support

DIETARY_SUPPLEMENT

Postoperative Nutrition

Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support

BEHAVIORAL

Preoperative Psychology

CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education

BEHAVIORAL

Postoperative Psychology

CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education

OTHER

Preoperative Nursing

Risk management, Managing pain, Wound care, Bowel function, Surgical education

OTHER

Postoperative Nursing

Risk management, Managing pain, Wound care, Bowel function/Stoma management, Education

BEHAVIORAL

Preoperative Peer Support Group

Fortnightly sessions moderated by a social worker including patients and carers: Safe space, Share experiences/ideas, Support, Education

BEHAVIORAL

Postoperative Peer Support Group

Fortnightly sessions moderated by a social worker including patients and carers: Safe space, Share experiences/ideas, Support, Education

Sponsors & Collaborators

• University of Sydney

  collaborator OTHER

• Medical Research Future Fund

  collaborator OTHER

• Surgical Outcomes Research Centre (SOuRCe)

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-15

Primary Completion

2028-07-30

Completion

2028-07-30

Countries

• Australia

Study Locations