Virtual Multimodal Hub for Patients Undergoing Colorectal Cancer Surgery - PRIORITY-CONNECT 2 Randomised Type I Hybrid Effectiveness-Implementation Trial

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Behavioral, Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Flinders Medical Centre
NOT_YET_RECRUITING
Adelaide
Lyell McEwin Hospital
NOT_YET_RECRUITING
Adelaide
Modbury Hospital
NOT_YET_RECRUITING
Adelaide
Royal Adelaide Hospital
NOT_YET_RECRUITING
Adelaide
Grampians Health Ballarat Hospital
NOT_YET_RECRUITING
Ballarat
Bendigo Health
NOT_YET_RECRUITING
Bendigo
Princess Alexandra Hospital
NOT_YET_RECRUITING
Brisbane
Royal Brisbane & Women's Hospital
NOT_YET_RECRUITING
Brisbane
The Queen Elizabeth II Jubilee Hospital
NOT_YET_RECRUITING
Brisbane
Cairns Hospital
NOT_YET_RECRUITING
Cairns
Coffs Harbour Health Campus
NOT_YET_RECRUITING
Coffs Harbour
University Hospital Geelong (Barwon Health)
NOT_YET_RECRUITING
Geelong
Alfred Hospital
NOT_YET_RECRUITING
Melbourne
Austin Hospital
NOT_YET_RECRUITING
Melbourne
Cabrini Hospital
NOT_YET_RECRUITING
Melbourne
Eastern (Box Hill) Hospital
NOT_YET_RECRUITING
Melbourne
Footscray Hospital
NOT_YET_RECRUITING
Melbourne
Northern Hospital Epping
NOT_YET_RECRUITING
Melbourne
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Royal Melbourne Hospital
NOT_YET_RECRUITING
Melbourne
St Vincent's Melbourne Hospital
NOT_YET_RECRUITING
Melbourne
Werribee Mercy Hospital
NOT_YET_RECRUITING
Melbourne
Calvary Mater Hospital
NOT_YET_RECRUITING
Newcastle
John Hunter Hospital
NOT_YET_RECRUITING
Newcastle
Royal Perth Hospital
NOT_YET_RECRUITING
Perth
Blacktown Hospital
NOT_YET_RECRUITING
Sydney
Chris O'Brien Lifehouse
RECRUITING
Sydney
Concord Repatriation General Hospital
NOT_YET_RECRUITING
Sydney
Royal Prince Alfred Hospital
RECRUITING
Sydney
Westmead Hospital
NOT_YET_RECRUITING
Sydney
Wagga Wagga Base Hospital
NOT_YET_RECRUITING
Wagga Wagga
Wollongong Hospital
NOT_YET_RECRUITING
Wollongong
Contact Information
Primary
Daniel Steffens, PhD
Daniel.Steffens@health.nsw.gov.au
+61 02 9515 3203
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2028-07-30
Participants
Target number of participants: 564
Treatments
Experimental: 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
Active_comparator: 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).
Related Therapeutic Areas
Sponsors
Collaborators: The University of Sydney, Sydney, Australia, Medical Research Future Fund
Leads: Surgical Outcomes Research Centre (SOuRCe)

This content was sourced from clinicaltrials.gov

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