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 Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach

1 country

2 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

December 13, 2023

Completed

1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed

24 days until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2025

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed

Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

December 13, 2023

Last Update Submit

April 23, 2024

Conditions

Liver Cancer Pancreas Cancer Oesophageal Cancer Gastric Cancer Colorectal Cancer

Keywords

PrehabilitationGastrointestinal cancerSurgerySurgical outcomesRandomised controlled trial

Outcome Measures

Primary Outcomes (2)

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
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 Outcomes (11)

Postoperative complications within 30 days after surgery
30 days after surgery
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.
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.
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.
Number of days at home within 30 and 90 days of surgery
days at home within 30 and 90 days of surgery
+6 more secondary outcomes

Study Arms (2)

Virtual Multimodal Hub and usual care (Intervention Group)

EXPERIMENTAL

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.

Behavioral: Preoperative ExerciseBehavioral: Postoperative ExerciseDietary Supplement: Preoperative NutritionDietary Supplement: Postoperative NutritionBehavioral: Preoperative PsychologyBehavioral: Postoperative PsychologyOther: Preoperative NursingOther: Postoperative NursingOther: Preoperative Peer Support GroupOther: Postoperative Peer Support GroupOther: Usual Care

Usual care alone (Control Group)

ACTIVE COMPARATOR

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.

Other: Usual Care