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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
Titles & IDs
Public title
PRIORITY-CONNECT 2 Pilot Trial
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Scientific title
Virtual Multimodal Hub for Patients Undergoing Major Gastrointestinal Cancer Surgery - PRIORITY-CONNECT 2 Pilot Randomised Type I Hybrid Effectiveness-Implementation Trial
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Secondary ID [1]
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X23-0399
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Liver Cancer
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Pancreas Cancer
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Oesophageal Cancer
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Gastric Cancer
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Colorectal Cancer
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Condition category
Condition code
Cancer
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Pancreatic
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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BEHAVIORAL
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Intervention code [2]
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Treatment: Other
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Intervention code [3]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility of the virtual multimodal hub determined by number of eligible participants, retention rate and adherence rates
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Assessment method [1]
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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.
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Timepoint [1]
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through study completion, an average of 1 year
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Primary outcome [2]
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Acceptability of the virtual multimodal hub.
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Assessment method [2]
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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.
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Timepoint [2]
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3 months, through study completion, an average of 1 year
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Secondary outcome [1]
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Postoperative complications within 30 days after surgery
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Assessment method [1]
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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.
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Timepoint [1]
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30 days after surgery
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Secondary outcome [2]
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Quality of life outcome EORTC QLQ-C30
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Assessment method [2]
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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.
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Timepoint [2]
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Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
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Secondary outcome [3]
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Quality of life outcome EORTC QLQ-OG25
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Assessment method [3]
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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.
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Timepoint [3]
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Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
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Secondary outcome [4]
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Quality of life outcome EORTC QLQ-CR29
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Assessment method [4]
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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.
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Timepoint [4]
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Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.
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Secondary outcome [5]
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Number of days at home within 30 and 90 days of surgery
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Assessment method [5]
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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).
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Timepoint [5]
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days at home within 30 and 90 days of surgery
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Secondary outcome [6]
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Resource use
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Assessment method [6]
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(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.
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Timepoint [6]
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1-6 weeks prior to surgery to 3 months post index surgery.
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Secondary outcome [7]
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Implementation Outcome: Reach
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Assessment method [7]
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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.
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Timepoint [7]
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through study completion, an average of 1 year
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Secondary outcome [8]
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Implementation Outcome: Effectiveness
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Assessment method [8]
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RE-AIM Framework, including:
Effectiveness: Measured through clinical outcomes, healthcare utilisation, participant satisfaction.
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Timepoint [8]
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through study completion, an average of 1 year
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Secondary outcome [9]
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Implementation Outcome: Adoption
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Assessment method [9]
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RE-AIM Framework, including:
Adoption: Measured through referral rates, enablers and barriers (surveys with patients, carers, surgeons, clinical and administrative staff post intervention).
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Timepoint [9]
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through study completion, an average of 1 year
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Secondary outcome [10]
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Implementation Outcome: Implementation
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Assessment method [10]
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RE-AIM Framework, including:
Implementation: measured through; Individual level: Participant adherence to virtual. Centre level: Implementation process, concordance with intervention protocol.
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Timepoint [10]
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through study completion, an average of 1 year
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Secondary outcome [11]
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Implementation Outcome: Maintenance
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Assessment method [11]
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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.
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Timepoint [11]
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through study completion, an average of 1 year
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/02/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/12/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Sydney
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Recruitment hospital [2]
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Royal Prince Alfred Hospital, Surgical Outcomes Research Centre (SOuRCe) - Sydney
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Recruitment postcode(s) [1]
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2050 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Surgical Outcomes Research Centre (SOuRCe)
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06212700
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Daniel Steffens, PhD
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Address
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Country
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Phone
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+61 02 9515 3203
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06212700