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
Surgical Outcomes Research Centre (SOuRCe)
20 participants
Feb 12, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Adults aged ≥18 years undergoing major gastrointestinal elective surgery, including liver, pancreas, oesophagus, gastric and colorectal cancer resections with curative intent
- Consulting with a gastrointestinal cancer surgeon at least 1 week prior to scheduled surgery
Exclusion Criteria2
- Cognitive impairment such that they are unable to provide informed consent
- No access to a smart device (including mobile phone, tablet, laptop or desk computer with camera) or no internet connection
Interventions
Aerobic (HIIT) Endurance Respiratory Muscle Strength Education
Aerobic Muscle Strength Walking Program Education
Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
CBT skills Skills training Emotional validation Behavioural activation Psycho-education
CBT skills Skills training Emotional validation Behavioural activation Psycho-education
Comorbidities Managing pain Wound care Complications Surgical education ERAS
Managing pain Cardiovascular stability Wound care Bowel function/Stoma Complications Education
Weekly sessions moderated by a social worker including patients and carers: Safe space Share experiences/ideas Support Education
Weekly sessions moderated by a social worker including patients and carers: Safe space Share experiences/ideas Support Education
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06212700