PRIORITY-CONNECT 2 Pilot Trial

Surgical Outcomes Research Centre (SOuRCe)

Status: Enrolling

Conditions: Oesophageal Cancer; Gastric Cancer; Pancreas Cancer; Liver Cancer; Colorectal Cancer

Treatments: Other: Postoperative Peer Support Group; Behavioral: Preoperative Psychology; Behavioral: Postoperative Psychology; Other: Preoperative Nursing; Other: Usual Care; Dietary Supplement: Preoperative Nutrition; Other: Postoperative Nursing; Dietary Supplement: Postoperative Nutrition; Behavioral: Postoperative Exercise; Behavioral: Preoperative Exercise; Other: Preoperative Peer Support Group

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06212700

X23-0399

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Virtual Multimodal Hub and usual care (Intervention Group)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Postoperative Nutrition

Other: Preoperative Nursing

Dietary Supplement: Preoperative Nutrition

Behavioral: Postoperative Exercise

Other: Usual Care

Other: Postoperative Peer Support Group

Other: Postoperative Nursing

Behavioral: Preoperative Exercise

Other: Preoperative Peer Support Group

Behavioral: Preoperative Psychology

Behavioral: Postoperative Psychology

Usual care alone (Control Group)

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care