Clinical trial NCT06212700: PRIORITY-CONNECT 2 Pilot Trial
Official title: Virtual Multimodal Hub for Patients Undergoing Major Gastrointestinal Cancer Surgery - PRIORITY-CONNECT 2 Pilot Randomised Type I Hybrid Effectiveness-Implementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cancer
Pancreas Cancer
Oesophageal Cancer
Gastric Cancer
Colorectal Cancer
Keywords: Prehabilitation
Gastrointestinal cancer
Surgery
Surgical outcomes
Randomised controlled trial
Lead sponsor: Surgical Outcomes Research Centre (SOuRCe)
Sponsor class: NETWORK
First posted: 2024-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Type I Hybrid Effectiveness-Implementation Trial
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Feasibility of the virtual multimodal hub determined by number of eligible participants, retention rate and adherence rates
timeFrame: through study completion, an average of 1 year
measure: Acceptability of the virtual multimodal hub.
timeFrame: 3 months, through study completion, an average of 1 year
Secondary outcomes:
measure: Postoperative complications within 30 days after surgery
timeFrame: 30 days after surgery
measure: Quality of life outcome EORTC QLQ-C30
timeFrame: Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
measure: Quality of life outcome EORTC QLQ-OG25
timeFrame: Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
measure: Quality of life outcome EORTC QLQ-CR29
timeFrame: Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
measure: Number of days at home within 30 and 90 days of surgery
timeFrame: days at home within 30 and 90 days of surgery
measure: Resource use
timeFrame: 1-6 weeks prior to surgery to 3 months post index surgery.
measure: Implementation Outcome: Reach
timeFrame: through study completion, an average of 1 year
measure: Implementation Outcome: Effectiveness
timeFrame: through study completion, an average of 1 year
measure: Implementation Outcome: Adoption
timeFrame: through study completion, an average of 1 year
measure: Implementation Outcome: Implementation
timeFrame: through study completion, an average of 1 year
measure: Implementation Outcome: Maintenance
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital, Surgical Outcomes Research Centre (SOuRCe)
state: New South Wales
Study officials:
References: