Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-02-12
2025-12-22
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
Preoperative Exercise
Aerobic (HIIT) Endurance Respiratory Muscle Strength Education
Postoperative Exercise
Aerobic Muscle Strength Walking Program Education
Preoperative Nutrition
Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
Postoperative Nutrition
Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
Preoperative Psychology
CBT skills Skills training Emotional validation Behavioural activation Psycho-education
Postoperative Psychology
CBT skills Skills training Emotional validation Behavioural activation Psycho-education
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.
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.
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.
Interventions
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Preoperative Exercise
Aerobic (HIIT) Endurance Respiratory Muscle Strength Education
Postoperative Exercise
Aerobic Muscle Strength Walking Program Education
Preoperative Nutrition
Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
Postoperative Nutrition
Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
Preoperative Psychology
CBT skills Skills training Emotional validation Behavioural activation Psycho-education
Postoperative Psychology
CBT skills Skills training Emotional validation Behavioural activation Psycho-education
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.
Eligibility Criteria
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Inclusion Criteria
* Consulting with a gastrointestinal cancer surgeon at least 1 week prior to scheduled surgery
Exclusion Criteria
* No access to a smart device (including mobile phone, tablet, laptop or desk computer with camera) or no internet connection
18 Years
ALL
No
Sponsors
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Surgical Outcomes Research Centre (SOuRCe)
NETWORK
Responsible Party
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Locations
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Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
Royal Prince Alfred Hospital, Surgical Outcomes Research Centre (SOuRCe)
Sydney, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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X23-0399
Identifier Type: -
Identifier Source: org_study_id
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