PRIORITY-CONNECT 2 Pilot Trial

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212700
• Other study ID #: X23-0399
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: December 22, 2025

Study information

• Verified date: April 2024
• Source: Surgical Outcomes Research Centre (SOuRCe)
• Contact: Daniel Steffens, PhD
• Phone: +61 02 9515 3203
• Email: Daniel.Steffens[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 22, 2025
• Est. primary completion date: July 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Gastric Cancer
• Liver Cancer
• Oesophageal Cancer
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Preoperative Exercise
Aerobic (HIIT) Endurance Respiratory Muscle Strength Education
• Postoperative Exercise
Aerobic Muscle Strength Walking Program Education

Dietary Supplement:
• Preoperative Nutrition
Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
• 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
• Postoperative Psychology
CBT skills Skills training Emotional validation Behavioural activation Psycho-education

Other:
• Preoperative Nursing
Comorbidities Managing pain Wound care Complications Surgical education ERAS
• Postoperative Nursing
Managing pain Cardiovascular stability Wound care Bowel function/Stoma Complications Education
• Preoperative Peer Support Group
Weekly sessions moderated by a social worker including patients and carers: Safe space Share experiences/ideas Support Education
• Postoperative Peer Support Group
Weekly sessions moderated by a social worker including patients and carers: Safe space Share experiences/ideas Support Education
• 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.

Locations

Country	Name	City	State
Australia	Chris O'Brien Lifehouse	Sydney	New South Wales
Australia	Royal Prince Alfred Hospital, Surgical Outcomes Research Centre (SOuRCe)	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Surgical Outcomes Research Centre (SOuRCe)

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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
Secondary	Implementation Outcome: Effectiveness	RE-AIM Framework, including: Effectiveness: Measured through clinical outcomes, healthcare utilisation, participant satisfaction.	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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