Clinical trial NCT06976710: PRIORITY-CONNECT 2 Trial
Official title: Virtual Multimodal Hub for Patients Undergoing Major Colorectal Cancer Surgery - PRIORITY-CONNECT 2 Randomised Type I Hybrid Effectiveness-Implementation Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Colorectal Neoplasms
Keywords: Prehabilitation
Colorectal Cancer
Surgery
Surgical Outcomes
Randomised Controlled Trial
Virtual Rehabilitation
Virtual Prehabilitation
Multidisciplinary
Virtual Care
Rehabilitation
Lead sponsor: Surgical Outcomes Research Centre (SOuRCe)
Sponsor class: NETWORK
Collaborators: name: The University of Sydney, Sydney, Australia
First posted: 2025-05-16
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 (pre)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: 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.

Detailed description: 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 randomised to the intervention group, 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 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:

* Cognitive impairment such that they are unable to provide informed consent

Primary outcomes:
measure: Proportion of participants developing postoperative complications within 30 days after surgery.
timeFrame: First 30-days after surgery
Secondary outcomes:
measure: Quality of life outcome EORTC QLQ-C30
timeFrame: 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.
measure: Quality of life outcome EORTC QLQ-CR29
timeFrame: 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.
measure: Quality of Recovery (QoR-15)
timeFrame: 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.
measure: Number of days at home within 30, 90 and 365 days of surgery (DAH-30, 90, 365)
timeFrame: Days at home within 30, 90 and 365 days of index surgery
measure: Resource use (costs)
timeFrame: Measured at baseline, 1, 3, 6 and 12 months post index surgery.
measure: Implementation outcome: Reach
timeFrame: Through study completion, an average of 12 months
measure: Implementation outcome: Effectiveness (quantitative and qualitative questionnaires)
timeFrame: Through study completion, an average of 12 months
measure: Implementation outcome: Adoption (quantitative and qualitative measures)
timeFrame: Through study completion, an average of 12 months
measure: Implementation outcome: Implementation (quantitative and qualitative measures)
timeFrame: Through study completion, an average of 12 months
measure: Implementation outcome: Maintenance
timeFrame: Through study completion, an average of 12 months
measure: Pain (NPRS)
timeFrame: 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.
measure: Exercise capacity (30sSTS)
timeFrame: 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.
measure: Self-reported physical activity (IPAQ-SF)
timeFrame: 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.
measure: Nutritional Status (PG-SGA SF)
timeFrame: 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.
measure: Anxiety (GAD-7)
timeFrame: 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.
measure: Depression (PHQ-9)
timeFrame: 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.
measure: Fear of cancer recurrence (FCR-1r)
timeFrame: 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.
measure: Adverse events (NHMRC Safety Monitoring and Reporting of Clinical Trials)
timeFrame: From date of opening recruitment to date of trial close-out
measure: Self-efficacy (GSE)
timeFrame: Measured at 1, 3, 6 and 12 months post index surgery.
measure: Treatment & Health Services
timeFrame: Measured at 1, 3, 6 and 12 months post index surgery.
measure: Satisfaction & Experience
timeFrame: Measured at 1, 3, 6 and 12 months post index surgery.
measure: Return to work
timeFrame: Measured between 1 and 12 months post index surgery.
Other outcomes:
measure: Acceptability of the intervention
timeFrame: Measured at 12 months post index surgery.
Locations:
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus
state: New South Wales
city: Newcastle
country: Australia
facility: Calvary Mater Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Wagga Wagga
country: Australia
facility: Wagga Wagga Base Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Brisbane
country: Australia
facility: The Queen Elizabeth II Jubilee Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Adelaide
country: Australia
facility: Modbury Hospital
state: South Australia
city: Adelaide
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Ballarat
country: Australia
facility: Grampians Health Ballarat Hospital
state: Victoria
city: Bendigo
country: Australia
facility: Bendigo Health
state: Victoria
city: Geelong
country: Australia
facility: University Hospital Geelong (Barwon Health)
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Footscray Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Werribee Mercy Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Northern Hospital Epping
state: Victoria
city: Melbourne
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Eastern (Box Hill) Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
References: