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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06212700




Registration number
NCT06212700
Ethics application status
Date submitted
13/12/2023
Date registered
19/01/2024
Date last updated
25/04/2024

Titles & IDs
Public title
PRIORITY-CONNECT 2 Pilot Trial
Scientific title
Virtual Multimodal Hub for Patients Undergoing Major Gastrointestinal Cancer Surgery - PRIORITY-CONNECT 2 Pilot Randomised Type I Hybrid Effectiveness-Implementation Trial
Secondary ID [1] 0 0
X23-0399
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Cancer 0 0
Pancreas Cancer 0 0
Oesophageal Cancer 0 0
Gastric Cancer 0 0
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Preoperative Exercise
BEHAVIORAL - Postoperative Exercise
Treatment: Other - Preoperative Nutrition
Treatment: Other - Postoperative Nutrition
BEHAVIORAL - Preoperative Psychology
BEHAVIORAL - Postoperative Psychology
Other interventions - Preoperative Nursing
Other interventions - Postoperative Nursing
Other interventions - Preoperative Peer Support Group
Other interventions - Postoperative Peer Support Group
Other interventions - Usual Care

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.

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.


BEHAVIORAL: Preoperative Exercise
Aerobic (HIIT) Endurance Respiratory Muscle Strength Education

BEHAVIORAL: Postoperative Exercise
Aerobic Muscle Strength Walking Program Education

Treatment: Other: Preoperative Nutrition
Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support

Treatment: Other: 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 interventions: Preoperative Nursing
Comorbidities Managing pain Wound care Complications Surgical education ERAS

Other interventions: Postoperative Nursing
Managing pain Cardiovascular stability Wound care Bowel function/Stoma Complications Education

Other interventions: Preoperative Peer Support Group
Weekly sessions moderated by a social worker including patients and carers:

Safe space Share experiences/ideas Support Education

Other interventions: Postoperative Peer Support Group
Weekly sessions moderated by a social worker including patients and carers:

Safe space Share experiences/ideas Support Education

Other interventions: 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.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Treatment: Other
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of the virtual multimodal hub determined by number of eligible participants, retention rate and adherence rates
Timepoint [1] 0 0
through study completion, an average of 1 year
Primary outcome [2] 0 0
Acceptability of the virtual multimodal hub.
Timepoint [2] 0 0
3 months, through study completion, an average of 1 year
Secondary outcome [1] 0 0
Postoperative complications within 30 days after surgery
Timepoint [1] 0 0
30 days after surgery
Secondary outcome [2] 0 0
Quality of life outcome EORTC QLQ-C30
Timepoint [2] 0 0
Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
Secondary outcome [3] 0 0
Quality of life outcome EORTC QLQ-OG25
Timepoint [3] 0 0
Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
Secondary outcome [4] 0 0
Quality of life outcome EORTC QLQ-CR29
Timepoint [4] 0 0
Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
Secondary outcome [5] 0 0
Number of days at home within 30 and 90 days of surgery
Timepoint [5] 0 0
days at home within 30 and 90 days of surgery
Secondary outcome [6] 0 0
Resource use
Timepoint [6] 0 0
1-6 weeks prior to surgery to 3 months post index surgery.
Secondary outcome [7] 0 0
Implementation Outcome: Reach
Timepoint [7] 0 0
through study completion, an average of 1 year
Secondary outcome [8] 0 0
Implementation Outcome: Effectiveness
Timepoint [8] 0 0
through study completion, an average of 1 year
Secondary outcome [9] 0 0
Implementation Outcome: Adoption
Timepoint [9] 0 0
through study completion, an average of 1 year
Secondary outcome [10] 0 0
Implementation Outcome: Implementation
Timepoint [10] 0 0
through study completion, an average of 1 year
Secondary outcome [11] 0 0
Implementation Outcome: Maintenance
Timepoint [11] 0 0
through study completion, an average of 1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital, Surgical Outcomes Research Centre (SOuRCe) - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Surgical Outcomes Research Centre (SOuRCe)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06212700
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daniel Steffens, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 02 9515 3203
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06212700