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Recruiting

PRIORITY-CONNECT 2 Trial

NCT06976710 · Surgical Outcomes Research Centre (SOuRCe)
In plain English

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Official title
Virtual Multimodal Hub for Patients Undergoing Colorectal Cancer Surgery - PRIORITY-CONNECT 2 Randomised Type I Hybrid Effectiveness-Implementation Trial
About this study
Further details on the study procedures: 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.
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study design
Enrollment target: 564 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-10-15
Estimated completion: 2028-07-30
Last updated: 2026-05-20
Interventions
Behavioral: Preoperative ExerciseBehavioral: Postoperative ExerciseDietary Supplement: Preoperative NutritionDietary Supplement: Postoperative NutritionBehavioral: Preoperative PsychologyBehavioral: Postoperative PsychologyOther: Preoperative NursingOther: Postoperative NursingBehavioral: Preoperative Peer Support GroupBehavioral: Postoperative Peer Support GroupOther: Usual Care
Primary outcomes
  • Proportion of participants developing postoperative complications within 30 days after surgery. (First 30-days after surgery)
Sponsor
Surgical Outcomes Research Centre (SOuRCe) · network
With: University of Sydney, Medical Research Future Fund
Contacts & investigators
ContactDaniel Steffens, PhD · contact · Daniel.Steffens@health.nsw.gov.au · +61 02 9515 3203
All locations (31)
Coffs Harbour Health CampusRecruiting
Coffs Harbour, New South Wales, Australia
Calvary Mater HospitalNot Yet Recruiting
Newcastle, New South Wales, Australia
John Hunter HospitalNot Yet Recruiting
Newcastle, New South Wales, Australia
Chris O'Brien LifehouseRecruiting
Sydney, New South Wales, Australia
Royal Prince Alfred HospitalRecruiting
Sydney, New South Wales, Australia
Concord Repatriation General HospitalNot Yet Recruiting
Sydney, New South Wales, Australia
Westmead HospitalNot Yet Recruiting
Sydney, New South Wales, Australia
Blacktown HospitalNot Yet Recruiting
Sydney, New South Wales, Australia
Wagga Wagga Base HospitalNot Yet Recruiting
Wagga Wagga, New South Wales, Australia
Wollongong HospitalNot Yet Recruiting
Wollongong, New South Wales, Australia
Royal Brisbane & Women's HospitalRecruiting
Brisbane, Queensland, Australia
Princess Alexandra HospitalNot Yet Recruiting
Brisbane, Queensland, Australia
The Queen Elizabeth II Jubilee HospitalNot Yet Recruiting
Brisbane, Queensland, Australia
Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Flinders Medical CentreNot Yet Recruiting
Adelaide, South Australia, Australia
Modbury HospitalRecruiting
Adelaide, South Australia, Australia
Lyell McEwin HospitalRecruiting
Adelaide, South Australia, Australia
Grampians Health Ballarat HospitalRecruiting
Ballarat, Victoria, Australia
Bendigo HealthNot Yet Recruiting
Bendigo, Victoria, Australia
University Hospital Geelong (Barwon Health)Recruiting
Geelong, Victoria, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Alfred HospitalNot Yet Recruiting
Melbourne, Victoria, Australia
Footscray HospitalRecruiting
Melbourne, Victoria, Australia
Werribee Mercy HospitalNot Yet Recruiting
Melbourne, Victoria, Australia
Royal Melbourne HospitalNot Yet Recruiting
Melbourne, Victoria, Australia
St Vincent's Melbourne HospitalNot Yet Recruiting
Melbourne, Victoria, Australia
Northern Hospital EppingRecruiting
Melbourne, Victoria, Australia
Austin HospitalNot Yet Recruiting
Melbourne, Victoria, Australia
Eastern (Box Hill) HospitalNot Yet Recruiting
Melbourne, Victoria, Australia
Cabrini HospitalNot Yet Recruiting
Melbourne, Victoria, Australia
Royal Perth HospitalNot Yet Recruiting
Perth, Western Australia, Australia
PRIORITY-CONNECT 2 Trial · TrialPath