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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Colorectal Cancer; Pancreas Cancer; Liver Cancer; Oesophageal Cancer
• Intervention / Treatment: Behavioral: Preoperative Exercise; Behavioral: Postoperative Exercise; Dietary supplement: Preoperative Nutrition; Dietary supplement: Postoperative Nutrition; Behavioral: Preoperative Psychology; Behavioral: Postoperative Psychology; Other: Preoperative Nursing; Other: Postoperative Nursing; Other: Preoperative Peer Support Group; Other: Postoperative Peer Support Group; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Steffens, PhD; Phone Number: +61 02 9515 3203; Email: Daniel.Steffens@health.nsw.gov.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2050
      • Recruiting
      • Chris O'Brien Lifehouse
      • Contact: Michael Solomon, DMed; Phone Number: +61 02 95153200; Email: professor.solomon@sydney.edu.au
    • Sydney, New South Wales, Australia, 2050
      • Recruiting
      • Royal Prince Alfred Hospital, Surgical Outcomes Research Centre (SOuRCe)
      • Contact: Daniel Steffens, PhD; Phone Number: +61 02 9515 3203; Email: Daniel.Steffens@health.nsw.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the virtual multimodal hub determined by number of eligible participants, retention rate and adherence rates	Feasibility will be determined by the following outcomes: (i) Number of eligible participants recruited to the pilot trial; (ii) Retention rate: defined as the percentage of participants who completed the trial; (iii) Adherence rates: defined as the percentage of planned sessions attended by those who were randomised to the intervention group.	through study completion, an average of 1 year
Acceptability of the virtual multimodal hub.	Patients, clinicians and carers acceptability to the virtual multimodal hub (Intervention) will be assessed with a semi-structured questionnaire administered at 3-months (last survey). The semi- structured questionnaire contains 11 questions and participants (Patients, clinicians and carers) will be instructed to use a 5-point Likert Scale to express how much they agree or disagree with each statement. In addition, patients will be asked how satisfied they were with the virtual multimodal program and if the program negatively affected them. The investigators have also taken the opportunity to seek further feedback about the virtual multimodal hub (open ended question). The questionnaire has been used on previous pilot trials.	3 months, through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications within 30 days after surgery	Defined as any deviation from the normal postoperative course and classified according to the Clavien-Dindo classification. The risk of developing complications following gastrointestinal cancer surgery is highest in the first 30-days after surgery; this is a critical determinant of recovery, long-term outcomes, and gastrointestinal cancer treatment costs.	30 days after surgery
Quality of life outcome EORTC QLQ-C30	EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 30-item cancer-specific tool measuring five functioning scales, nine symptom scales, financial impact and overall QoL. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
Quality of life outcome EORTC QLQ-OG25	EORTC QLQ-OG25 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 25-item tool measuring function and symptoms specific to oesophoago-gastric cancer. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
Quality of life outcome EORTC QLQ-CR29	EORTC QLQ-CR29 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 29-item tool measuring function and symptoms specific to colorectal cancer. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
Number of days at home within 30 and 90 days of surgery	DAH-30, 90 (days at home 30, 90): Validated (Australian population) patient-centred outcome metrics that integrates length of hospital stay, discharge destination (other than home), hospital readmission and early death. The number of days at home - reduced by complications, discharge to a care facility, re-admission, and death is quantified as the days alive and at home during the 30 days after surgery. DAH-30, 90 is calculated using mortality and hospitalisation data from the date of the index surgery (= Day 0).	days at home within 30 and 90 days of surgery
Resource use	(Costs): Patient and health system resource use, including the cost of the virtual multimodal hub interventions, hospitalisations, will be collected (surveys) from randomisation (1-6 weeks prior to surgery) to 3 months post index surgery.	1-6 weeks prior to surgery to 3 months post index surgery.
Implementation Outcome: Reach	RE-AIM Framework, including: Reach: Measured through trial participation, baseline characteristics (referral pathways, age, postcode, marital, work status, and Culturally And Linguistically Diverse [CALD]) of all potential participants.	through study completion, an average of 1 year
Implementation Outcome: Effectiveness	RE-AIM Framework, including: Effectiveness: Measured through clinical outcomes, healthcare utilisation, participant satisfaction.	through study completion, an average of 1 year
Implementation Outcome: Adoption	RE-AIM Framework, including: Adoption: Measured through referral rates, enablers and barriers (surveys with patients, carers, surgeons, clinical and administrative staff post intervention).	through study completion, an average of 1 year
Implementation Outcome: Implementation	RE-AIM Framework, including: Implementation: measured through; Individual level: Participant adherence to virtual. Centre level: Implementation process, concordance with intervention protocol.	through study completion, an average of 1 year
Implementation Outcome: Maintenance	RE-AIM Framework, including: Maintenance: Measured through rates of referral over time of the study; stakeholder interviews regarding refinements and infrastructure needed to maintain and scale intervention beyond the project period.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Surgical Outcomes Research Centre (SOuRCe)

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): July 22, 2025
• Study Completion (Estimated): December 22, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Randomised controlled trial; Prehabilitation; Surgical outcomes; Gastrointestinal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: X23-0399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No