Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
564 participants
INTERVENTIONAL
2025-10-15
2028-07-30
Brief Summary
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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.
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Detailed Description
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Patients will be identified by their treating team (including but not limited to colorectal surgeon, allied health, research and nursing staff). The treating team will screen and provide the 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). Patients will undergo an immediate second randomisation to determine their virtual hub assignment (Royal Prince Alfred Hospital Hub or The Peter MacCallum Cancer Centre Hub).
The participants randomised into the intervention group will then be contacted by a range of allied health workers, depending on their individual needs. These may include a physiotherapist, dietitian, psychologist, nurse and/ or a social worker. The intervention will provide the participants support as they navigate the health system. These health workers will communicate with them via the virtual hub for sessions to provide support before surgery and help with their recovery. Participant's individual needs will determine the frequency, intensity, time, type, volume, and progression of these sessions. This intervention may last for up to 12 months after their surgery, but they will be discharged from the intervention once they have reached their treatment goals. If participants do not have access to a smart device and/or internet, the investigators can provide them with a tablet with internet connectivity to engage in virtual delivery of sessions.
Data and safety monitoring:
An independent Data and Safety Monitoring Board (DSMB), will be monitored by a multidisciplinary panel (including statistician(s)). This panel will assess for adverse events and adherence to the protocol at regular intervals to ensure the safety of participants. The frequency of DSMB meetings and the stopping rules for the study will be defined a priori in a charter, in consultation with the DSMB members and study investigators. This will include after commencing participant recruitment and once one fourth of participants have been recruited.
ProCoMida:
The PRO CoMiDa form is a data management tool, designed to provide standardised documentation of the completion, or reasons for non-completion, of patient reported outcomes assessments by patients in a clinical trial. Such documentation is crucial for quality assurance since missing data is the greatest threat to the integrity and interpretability of patient reported outcomes data. The PRO CoMiDa form must be completed at each scheduled patient reported outcomes assessment.
GCP Certificates:
The trial will conform to all relevant ICH GCP guidelines and regulations. Annual audits will be conducted by research officers to ensure that all study staff maintain current GCP certification.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Virtual Multimodal Hub and usual care (Intervention Group)
The 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
Preoperative Exercise
Aerobic, Endurance, Respiratory, Muscle Strength, Education
Postoperative Exercise
Aerobic, Endurance, Respiratory, Muscle Strength, Education
Preoperative Nutrition
Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support
Postoperative Nutrition
Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support
Preoperative Psychology
CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education
Postoperative Psychology
CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education
Preoperative Nursing
Risk management, Managing pain, Wound care, Bowel function, Surgical education
Postoperative Nursing
Risk management, Managing pain, Wound care, Bowel function/Stoma management, Education
Preoperative Peer Support Group
Fortnightly sessions moderated by a social worker including patients and carers:
Safe space, Share experiences/ideas, Support, Education
Postoperative Peer Support Group
Fortnightly sessions moderated by a social worker including patients and carers:
Safe space, Share experiences/ideas, Support, Education
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.
Usual care alone (Control Group)
Participants 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).
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.
Interventions
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Preoperative Exercise
Aerobic, Endurance, Respiratory, Muscle Strength, Education
Postoperative Exercise
Aerobic, Endurance, Respiratory, Muscle Strength, Education
Preoperative Nutrition
Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support
Postoperative Nutrition
Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support
Preoperative Psychology
CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education
Postoperative Psychology
CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education
Preoperative Nursing
Risk management, Managing pain, Wound care, Bowel function, Surgical education
Postoperative Nursing
Risk management, Managing pain, Wound care, Bowel function/Stoma management, Education
Preoperative Peer Support Group
Fortnightly sessions moderated by a social worker including patients and carers:
Safe space, Share experiences/ideas, Support, Education
Postoperative Peer Support Group
Fortnightly sessions moderated by a social worker including patients and carers:
Safe space, Share experiences/ideas, Support, Education
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.
Eligibility Criteria
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Inclusion Criteria
* Consulting with a colorectal cancer surgeon at least 1 week prior to scheduled surgery
Exclusion Criteria
* Cognitive impairment such that they are unable to provide informed consent
18 Years
ALL
No
Sponsors
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The University of Sydney, Sydney, Australia
UNKNOWN
Medical Research Future Fund
OTHER
Surgical Outcomes Research Centre (SOuRCe)
NETWORK
Responsible Party
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Locations
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Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Calvary Mater Hospital
Newcastle, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Concord Repatriation General Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Blacktown Hospital
Sydney, New South Wales, Australia
Wagga Wagga Base Hospital
Wagga Wagga, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Royal Brisbane & Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
The Queen Elizabeth II Jubilee Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Modbury Hospital
Adelaide, South Australia, Australia
Lyell McEwin Hospital
Adelaide, South Australia, Australia
Grampians Health Ballarat Hospital
Ballarat, Victoria, Australia
Bendigo Health
Bendigo, Victoria, Australia
University Hospital Geelong (Barwon Health)
Geelong, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Footscray Hospital
Melbourne, Victoria, Australia
Werribee Mercy Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
St Vincent's Melbourne Hospital
Melbourne, Victoria, Australia
Northern Hospital Epping
Melbourne, Victoria, Australia
Austin Hospital
Melbourne, Victoria, Australia
Eastern (Box Hill) Hospital
Melbourne, Victoria, Australia
Cabrini Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Andrew Sutherland
Role: primary
Stephen Smith
Role: primary
Stephen Smith
Role: primary
Michael Solomon
Role: primary
Michael Suen
Role: primary
Yanlan Lin
Role: backup
Amy Cao
Role: primary
Rajni Lal
Role: primary
Danette Wright
Role: backup
Stephen Jancewicz
Role: primary
Robert Winn
Role: primary
Andrew Still
Role: backup
David Clark
Role: primary
Chris Gillespie
Role: primary
Natalie Mazzeo
Role: backup
Chris Gillespie
Role: primary
Tarik Sammour
Role: primary
Tracy Fitzsimmons
Role: backup
Dayan De Fontgalland
Role: primary
Elizabeth Murphy
Role: primary
Hoang Van
Role: backup
Elizabeth Murphy
Role: primary
Hoang Van
Role: backup
Fernando Arduini
Role: primary
Natasha Brice
Role: backup
Angus Lee
Role: primary
Kate Booth
Role: backup
Douglas Stupart
Role: primary
Anne Vandewater
Role: backup
Bernard Riedel
Role: primary
Tom Poulton
Role: backup
Joseph Kong
Role: primary
Justin Yeung
Role: primary
Howard Tang
Role: backup
Toan Pham
Role: primary
Tess Asgill
Role: backup
Jacob McCormick
Role: primary
Corina Behrenbruch
Role: primary
James Keck
Role: backup
Basil D'Souza
Role: primary
Andrea Ditoro
Role: backup
Helen Mohan
Role: primary
Vinna An
Role: primary
Wei Ming
Role: backup
Joseph Kong
Role: primary
Vicki Patton
Role: primary
Other Identifiers
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X23-0399 Phase 2
Identifier Type: -
Identifier Source: org_study_id
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