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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Chris O'Brien Lifehouse
RECRUITING
Sydney
Royal Prince Alfred Hospital, Surgical Outcomes Research Centre (SOuRCe)
RECRUITING
Sydney
Contact Information
Primary
Daniel Steffens, PhD
Daniel.Steffens@health.nsw.gov.au
+61 02 9515 3203
Time Frame
Start Date: 2024-02-12
Estimated Completion Date: 2025-12-22
Participants
Target number of participants: 20
Treatments
Experimental: Virtual Multimodal Hub and usual care (Intervention Group)
The main aim of the virtual multimodal hub is to prepare participants for surgery (including the role of Enhanced Recovery after Surgery (ERAS) pathway) and support declines in physiological and psychological function associated with preoperative treatments (e.g., chemo-radiotherapy) and major surgery. The post-hospital discharge interventions will focus on the recovery of activities of daily living, occupational tasks, and recreational activities. Aided by standardised assessment tools, a comprehensive holistic baseline (first preoperative multimodal session) and post-discharge (first postoperative multimodal session) assessment of patients' physical, nutritional, psychological and overall health status, presence of co-morbidities and medical history will determine the frequency, intensity, time, type, volume, and progression of the multimodal interventions.
Active_comparator: Usual care alone (Control Group)
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. Participants will be asked to maintain their normal daily activities.
Sponsors
Leads: Surgical Outcomes Research Centre (SOuRCe)

This content was sourced from clinicaltrials.gov