RESET (Ready for Safe Cancer Treatment) – a comprehensive tool for improving quality and optimizing perioperative care and safe discharge planning in surgical oncology: study protocol for a large-scale long-term trial including a randomized control group, with elements of exploratory cross-sectional study.
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Background Prolonged hospitalizations and rehospitalizations are common challenges in oncological surgery, often resulting in increased morbidity, increased healthcare costs, and diminished patient outcomes. Addressing these issues requires a comprehensive, evidence-based approach that integrates multiple dimensions of perioperative care. The study introduces a structured Ready for Safe Cancer Treatment (RESET) protocol incorporating prehabilitation, enhanced recovery strategies, and a robust transitional care program to optimize treatment pathways and improve patient outcomes in oncological and nononcological surgical settings. By standardizing perioperative care pathways, the proposed protocol aims to enhance recovery, reduce the rates of prolonged hospitalizations and rehospitalizations, ensure seamless continuity of care, and improve resource utilization while improving overall patient outcomes. Methods RESET is a long-term experimental study involving four interconnected intervention modules: prehabilitation, hospitalization, postoperative recovery, and transitional care. Prehabilitation focuses on preparing patients physically, nutritionally, and psychologically for surgery. Interventions include personalized nutritional, pharmacological, physical, and psychological support coordinated through dedicated tools such as a mobile application, SAFER bundle, and compliance monitoring systems. Postoperative recovery integrates active rehabilitation, complication monitoring, and caregiver involvement. Finally, transitional care ensures continuity through follow-up and remote monitoring tools. The study will enrol 12,000 participants who are randomized into intervention and control groups, with stratification by oncology and nononcology patients with tailored inclusion criteria for each. Outcomes, including prolonged hospitalizations, rehospitalizations, and postoperative complications, were analyzed via advanced statistical methods. Rigorous blinding, data validation, and quality control ensure the reliability of the study, while the multilevel structure of the intervention addresses the holistic needs of patients undergoing surgical procedures. Discussion The RESET study results may provide a novel, comprehensive approach to perioperative care, addressing gaps in traditional models by combining prehabilitation with structured postoperative and transitional care. It is anticipated that this study will lead to measurable improvements in patient recovery, reduced hospital stays, and enhanced overall satisfaction. Furthermore, the findings aim to provide actionable insights for integrating these interventions into broader healthcare networks. Trial registration The study protocol was submitted to the Medical Research Agency, as part of application process No. ABM/2024/2 on 14 Nov 2024, and received the identification number 2024/ABM/02/00051. The designed study is a medical research experiment, but it is not classified as a clinical trial under the applicable regulations. Therefore, it does not require registration in the Clinical Trials Information System (European Union). Specifically, it does not involve testing medicinal products, medical devices, or interventions aimed at generating evidence for regulatory approval. Instead, the study focuses on evaluating and implementing a structured protocol for optimizing perioperative care through established, evidence-based practices. Its primary objective is to improve healthcare processes and patient outcomes rather than test new treatments or investigational procedures, which exempts it from mandatory clinical trial registration requirements.