Colorectal Cancer, Gastric Cancer, Liver Cancer, Oesophageal Cancer, Pancreas Cancer
Conditions
Keywords
Prehabilitation, Gastrointestinal cancer, Surgery, Surgical outcomes, Randomised controlled trial
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.
Interventions
BEHAVIORALPreoperative Exercise
Aerobic (HIIT) Endurance Respiratory Muscle Strength Education
BEHAVIORALPostoperative Exercise
Aerobic Muscle Strength Walking Program Education
DIETARY_SUPPLEMENTPreoperative Nutrition
Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
DIETARY_SUPPLEMENTPostoperative Nutrition
Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support
BEHAVIORALPreoperative Psychology
CBT skills Skills training Emotional validation Behavioural activation Psycho-education
BEHAVIORALPostoperative Psychology
CBT skills Skills training Emotional validation Behavioural activation Psycho-education
OTHERPreoperative Nursing
Comorbidities Managing pain Wound care Complications Surgical education ERAS
Managing pain Cardiovascular stability Wound care Bowel function/Stoma Complications Education
Weekly sessions moderated by a social worker including patients and carers: Safe space Share experiences/ideas Support Education
Weekly sessions moderated by a social worker including patients and carers: Safe space Share experiences/ideas Support Education
OTHERUsual 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.
Sponsors
Surgical Outcomes Research Centre (SOuRCe)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Consenting participants will undergo baseline assessment immediately prior to randomisation to intervention (virtual multimodal hub and usual care) or control group (usual care alone). The randomisation sequence will be prepared a priori using a central secure randomisation service (1:1 allocation ratio in random permuted blocks of sizes 4 or 2 stratified by hospital, to ensure balance intreatment assignment within hospital) to ensure concealment of treatment allocation and blinding of surgeon, all trial personnel and statistician. Due to the nature of the intervention, it is not possible to blind the clinicians delivering the intervention (virtual multimodal hub); however, the investigators will ensure that all patients' interactions are standardised.
Intervention model description
Randomised Type I Hybrid Effectiveness-Implementation Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the virtual multimodal hub determined by number of eligible participants, retention rate and adherence rates | through study completion, an average of 1 year | 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. |
| Acceptability of the virtual multimodal hub. | 3 months, through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life outcome EORTC QLQ-OG25 | Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery. | 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. |
| Quality of life outcome EORTC QLQ-CR29 | Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery. | 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. |
| Number of days at home within 30 and 90 days of surgery | 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). |
| Resource use | 1-6 weeks prior to surgery to 3 months post index surgery. | (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. |
| Postoperative complications within 30 days after surgery | 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. |
| Implementation Outcome: Effectiveness | through study completion, an average of 1 year | RE-AIM Framework, including: Effectiveness: Measured through clinical outcomes, healthcare utilisation, participant satisfaction. |
| Implementation Outcome: Adoption | through study completion, an average of 1 year | RE-AIM Framework, including: Adoption: Measured through referral rates, enablers and barriers (surveys with patients, carers, surgeons, clinical and administrative staff post intervention). |
| Implementation Outcome: Implementation | through study completion, an average of 1 year | RE-AIM Framework, including: Implementation: measured through; Individual level: Participant adherence to virtual. Centre level: Implementation process, concordance with intervention protocol. |
| Implementation Outcome: Maintenance | through study completion, an average of 1 year | 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. |
| Implementation Outcome: Reach | through study completion, an average of 1 year | 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. |
| Quality of life outcome EORTC QLQ-C30 | Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery. | 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. |
Countries
Australia
Contacts
Primary ContactDaniel Steffens, PhD
Outcome results
None listed