PRIORITY-CONNECT 2 Pilot Trial

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

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.

Sponsors & Collaborators

• Surgical Outcomes Research Centre (SOuRCe)

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-12

Primary Completion

2025-07-22

Completion

2025-12-22

Countries

• Australia

Study Locations