NCT06212700

PRIORITY-CONNECT 2 Pilot Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Surgical Outcomes Research Centre (SOuRCe) · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The provision of preoperative interventions (prehabilitation: including exercise, nutrition, and psychological treatment) have been reported to reduce postoperative complications by as much as 50% and reduce hospital stay by up to 4 days compared to standard of care. Postoperative multimodal interventions are likely to further benefit patients facing new challenges (e.g. stoma care), and reduce post discharge complications. Therefore the Virtual Multimodal hub of PRIORITY-CONNECT 2 Pilot Trial aims to primarily; determine the feasibility of incorporating a virtual multimodal program into the preoperative and postoperative period for patients undergoing gastrointestinal cancer surgery, the acceptability to patients, clinicians and carers of the virtual multimodal program and the acceptability to patients of being randomised to the virtual multimodal program or usual care. The secondary aim is to obtain pilot data on the likely difference in key outcomes (30 days postoperative complications, quality of life, days at home and alive at 30 days - DAH30, implementation outcomes and cost outcomes) to inform the development of a substantive randomised clinical trial.

Conditions

• Liver Cancer
• Pancreas Cancer
• Oesophageal Cancer
• Gastric Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Preoperative Exercise	Aerobic (HIIT) Endurance Respiratory Muscle Strength Education
BEHAVIORAL	Postoperative Exercise	Aerobic Muscle Strength Walking Program Education
DIETARY_SUPPLEMENT	Preoperative Nutrition	Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
DIETARY_SUPPLEMENT	Postoperative Nutrition	Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
BEHAVIORAL	Preoperative Psychology	CBT skills Skills training Emotional validation Behavioural activation Psycho-education
BEHAVIORAL	Postoperative Psychology	CBT skills Skills training Emotional validation Behavioural activation Psycho-education
OTHER	Preoperative Nursing	Comorbidities Managing pain Wound care Complications Surgical education ERAS
OTHER	Postoperative Nursing	Managing pain Cardiovascular stability Wound care Bowel function/Stoma Complications Education
OTHER	Preoperative Peer Support Group	Weekly sessions moderated by a social worker including patients and carers: Safe space Share experiences/ideas Support Education
OTHER	Postoperative Peer Support Group	Weekly sessions moderated by a social worker including patients and carers: Safe space Share experiences/ideas Support Education
OTHER	Usual Care	Participants allocated to the control group 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.

Timeline

• Start date: 2024-02-12
• Primary completion: 2025-07-22
• Completion: 2025-12-22
• First posted: 2024-01-19
• Last updated: 2024-04-25

Locations

2 sites across 1 country: Australia