Patient and public involvement in the co-design of a multicenter randomized controlled trial on prehabilitation: results from the PREHAB-PEER conceptual phase

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BACKGROUND: Multimodal prehabilitation before colorectal cancer surgery (CRC) aims to enhance patients' physical and psychological resilience before surgery and support postoperative recovery. However, previous prehabilitation trials have reported heterogeneous findings and faced challenges related to intervention complexity, adherence, patient burden, and outcome selection. These limitations highlight the need to involve patients and other stakeholders early in the design of complex prehabilitation trials. METHODS: This mixed-methods conceptual phase was designed to translate patient and stakeholder perspectives into a feasible randomized controlled trial (RCT) design. Patient, clinical, scientific, and organizational stakeholder groups were identified, followed by the application of complementary involvement methods, including a nationwide patient survey, iterative focus group meetings with the Patient Advisory Board (PAB) of the Study Center of the German Society of Surgery (SDGC), collaboration with patient support initiatives, and an interprofessional expert workshop. Findings were integrated to guide key design decisions, including the target population, intervention components, delivery setting, primary endpoint, and implementation strategies. Barriers to trial participation and adherence were identified and addressed through co-developed mitigation strategies. RESULTS: During a 12-month structured conceptual phase, scientific and clinical experts together with patient representatives developed a patient-centered study design for the multicenter PREHAB-PEER RCT investigating the effect of a personalized multimodal prehabilitation program in CRC patients. It was decided to select a patient population with increased perioperative risk, composed of the factors age, frailty and nutrition status, for an outpatient supervised four component prehabilitation intervention. Quality of Recovery, a patient reported outcome, was chosen as the primary endpoint. DISCUSSION: This conceptual development study demonstrates how structured patient and stakeholder involvement can be used to shape the design of a complex clinical trial and improve alignment with patient priorities. It underscores the role of structured contribution of patient representatives in trial design and sets the foundation for the subsequent trial to provide high-quality evidence regarding prehabilitation in CRC care.

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