PRIORITY-CONNECT 2 Trial
PC2
Virtual Multimodal Hub for Patients Undergoing Colorectal Cancer Surgery - PRIORITY-CONNECT 2 Randomised Type I Hybrid Effectiveness-Implementation Trial
1 other identifier
interventional
564
1 country
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Oct 2025
Typical duration for not_applicable colorectal-cancer
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
October 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2028
May 20, 2026
May 1, 2026
2.8 years
April 13, 2025
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants developing postoperative complications within 30 days after surgery.
The primary outcome will be the proportion of participants developing postoperative complications within 30 days after surgery, defined as any deviation from the normal postoperative course and classified according to the Clavien-Dindo classification. The risk of developing complications following colorectal cancer surgery is highest in the first 30-days after surgery; this is a critical determinant of recovery, long-term outcomes, and colorectal cancer treatment costs.
First 30-days after surgery
Secondary Outcomes (5)
Quality of Life Outcome (EORTC QLQ-C30 and QLQ-CR29)
Measured at baseline, 1-2 day(s) before surgery, perioperative (within 1 day of hospital discharge), 1, 3, 6 and 12 months post index surgery.
Quality of Recovery (QoR-15)
Measured at baseline, 1-2 day(s) before surgery, perioperative (within 1 day of hospital discharge), 1, 3, 6 and 12 months post index surgery.
Number of days at home within 30, 90 and 365 days of surgery (DAH-30, 90, 365)
Days at home within 30, 90 and 365 days of index surgery
Resource use (costs)
Measured at baseline, 1, 3, 6 and 12 months post index surgery.
Implementation metrics: (RE-AIM)
Through study completion, an average of 12 months
Other Outcomes (13)
Pain (NPRS)
Measured at baseline, 1-2 day(s) before surgery, perioperative (within 1 day of hospital discharge), 1, 3, 6 and 12 months post index surgery.
Exercise capacity (30sSTS)
Measured at baseline, 1-2 day(s) before surgery, perioperative (within 1 day of hospital discharge), 1, 3, 6 and 12 months post index surgery.
Self-reported physical activity (IPAQ-SF)
Measured at baseline, 1-2 day(s) before surgery, perioperative (within 1 day of hospital discharge), 1, 3, 6 and 12 months post index surgery.
- +10 more other outcomes
Study Arms (2)
Virtual Multimodal Hub and usual care (Intervention Group)
EXPERIMENTALThe intervention is a multicomponent virtual hub which encompasses medical, social, psychological and functional assessment(s) and intervention(s). Following a comprehensive holistic assessment, clinicians will tailor the intervention subject to individual's presentation and needs. This may include evidence-based exercise, nutritional, psychological and nursing interventions, and /or group-delivered peer support, in addition to usual care. Adjustments and progression will be made in each session according to an individual's response. All interventions will be conducted before and after surgery. Standardised assessment tools will guide the frequency, intensity, duration, type, volume, and progression of the multimodal interventions, with the potential for the intervention(s) to be stepped-up or stepped-down based on individual patient needs
Usual care alone (Control Group)
ACTIVE COMPARATORParticipants allocated to the control group will only 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. Participants will be asked to maintain their normal daily activities. No attempt will be made to alter the routine care pathway. The use of any additional service will be recorded to inform the comprehensive cost analysis (linked to PBS and MBS data).
Interventions
CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education
CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education
Risk management, Managing pain, Wound care, Bowel function, Surgical education
Fortnightly sessions moderated by a social worker including patients and carers: Safe space, Share experiences/ideas, Support, Education
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.
Aerobic, Endurance, Respiratory, Muscle Strength, Education
Aerobic, Endurance, Respiratory, Muscle Strength, Education
Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support
Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support
Risk management, Managing pain, Wound care, Bowel function/Stoma management, Education
Fortnightly sessions moderated by a social worker including patients and carers: Safe space, Share experiences/ideas, Support, Education
Eligibility Criteria
You may qualify if:
- Adults aged ≥18 years undergoing elective major surgery for colon or rectal cancer with curative intent
- Consulting with a colorectal cancer surgeon at least 1 week prior to scheduled surgery
You may not qualify if:
- Patients undergoing Pelvic Exenteration (PE), Cytoreductive Surgery (CRS) with or without HIPEC, or concurrent surgery for metastatic disease
- Cognitive impairment such that they are unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Surgical Outcomes Research Centre (SOuRCe)lead
- Medical Research Future Fundcollaborator
- University of Sydneycollaborator
Study Sites (31)
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450, Australia
Calvary Mater Hospital
Newcastle, New South Wales, 2298, Australia
John Hunter Hospital
Newcastle, New South Wales, 2305, Australia
Chris O'Brien Lifehouse
Sydney, New South Wales, 2050, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Concord Repatriation General Hospital
Sydney, New South Wales, 2139, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Blacktown Hospital
Sydney, New South Wales, 2148, Australia
Wagga Wagga Base Hospital
Wagga Wagga, New South Wales, 2650, Australia
Wollongong Hospital
Wollongong, New South Wales, 2500, Australia
Royal Brisbane & Women's Hospital
Brisbane, Queensland, 4029, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
The Queen Elizabeth II Jubilee Hospital
Brisbane, Queensland, 4108, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Adelaide, South Australia, 5042, Australia
Modbury Hospital
Adelaide, South Australia, 5092, Australia
Lyell McEwin Hospital
Adelaide, South Australia, 5112, Australia
Grampians Health Ballarat Hospital
Ballarat, Victoria, 3350, Australia
Bendigo Health
Bendigo, Victoria, 3550, Australia
University Hospital Geelong (Barwon Health)
Geelong, Victoria, 3220, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Footscray Hospital
Melbourne, Victoria, 3011, Australia
Werribee Mercy Hospital
Melbourne, Victoria, 3030, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
St Vincent's Melbourne Hospital
Melbourne, Victoria, 3065, Australia
Northern Hospital Epping
Melbourne, Victoria, 3076, Australia
Austin Hospital
Melbourne, Victoria, 3084, Australia
Eastern (Box Hill) Hospital
Melbourne, Victoria, 3128, Australia
Cabrini Hospital
Melbourne, Victoria, 3144, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The randomisation sequence will be prepared a priori using a central secure randomisation service (1:1 allocation ratio in random permuted blocks of sizes 4 or 2 stratified by hospital, to ensure balance in treatment assignment within hospital) to ensure concealment of treatment allocation and blinding of surgeon, all trial personnel, health economist and statistician. Due to the nature of the intervention, it is not possible to blind the clinicians delivering the intervention (virtual multimodal hub); however, the investigators will ensure that all patients' interactions are standardised according to standard operating procedures (SOPs).
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2025
First Posted
May 16, 2025
Study Start
October 15, 2025
Primary Completion (Estimated)
July 30, 2028
Study Completion (Estimated)
July 30, 2028
Last Updated
May 20, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will only be made available upon individual request following the completion of the project. It will be at the discretion of the Principal Investigator (A/Prof Daniel Steffens) when this has been achieved. Once available, data may be accessed for up to 15 years after the trial's closure, after which it will be destroyed in accordance with the protocol.
- Access Criteria
- Based on explicit consent from individual participants, de-identified individual patient data (IPD) will be made available to researchers who comply with all regulations stipulated by a NHMRC-approved Human Research Ethics Committee (HREC). Subject to the discretion of both the Principal Investigator and a NHMRC-approved HREC, data will be made available for any approved analyses. Researchers interested in accessing IPD must submit a request to the Principal Investigator, A/Prof Daniel Steffens (daniel.steffens@health.nsw.gov.au). Mechanisms for data sharing will be in line with the Research Data Management Plan and a transfer process stipulated by a NHRMC approved HREC.
Following explicit informed consent from individual participants, any de-identified data will be shared for studies approved by both the Principal Investigator (A/Prof Daniel Steffens) and a NHRMC approved Human Research Ethics Committee (HREC).