Virtual multimodal hub for patients undergoing major gastrointestinal cancer surgery (PRIORITY-CONNECT 2 Pilot) - A pilot randomised type I hybrid effectiveness-implementation trial
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Abstract
Background
The PRIORITY-CONNECT 2 pilot trial will establish the feasibility and acceptability of a virtual multimodal programme following gastrointestinal cancer surgery. The secondary aims are to obtain pilot data on the likely difference in key outcomes, data elements that will guide future implementation studies, and to identify barriers and facilitators that inform the development and execution of a substantive randomised clinical effectiveness trial of teleprehabilitation/rehabilitation.
Methods
This is a multicentre, assessor-blinded, pilot, randomised controlled trial utilising a Hybrid Type I effectiveness-implementation design. 20 participants undergoing major gastrointestinal cancer surgery will be randomised (1:1 allocation) to attend a virtual multimodal prehabilitation-rehabilitation hub (intervention group), delivered before (1–6 weeks) and after (up to 3 months) surgery plus usual care, or to usual care alone (control group). An individualised intervention will be delivered by an experienced multidisciplinary team including a physiotherapist, psychologist, dietitian, nurse, social worker, and a geriatrician. Outcomes will be collected at baseline, 1–2 days before surgery, during the hospital stay, day of discharge from hospital, and 3 months postoperatively. The primary outcomes will be feasibility and acceptability of the virtual multimodal hub. Secondary outcomes assess the rate of postoperative complications within 30 days after surgery, quality of life, the number of days at home within 30 and 90 days after surgery, healthcare use, and implementation outcomes.
Discussion
The PRIORITY-CONNECT 2 pilot trial will generate findings about the feasibility and acceptability of delivering an evidence-based virtual multimodal preoperative (prehabilitation) and postoperative (rehabilitation) intervention targeting patients having major gastrointestinal cancer surgery.
Trial registration
This trial was registered prospectively with the National Library of Medicine ClinicalTrials.gov Registry (NCT06212700) on 8th January 2024.
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