The goal of this randomized controlled clinical trial is to evaluate whether the Ready for Safe Cancer Treatment (RESET) program improves perioperative care and supports safe hospital discharge in two surgical populations: adult patients undergoing planned oncological surgery and patients aged 70 years or older undergoing planned non-oncological surgery under general anesthesia.
RESET is a comprehensive, multidisciplinary care pathway that combines prehabilitation, standardized perioperative care, enhanced recovery, and individualized transitional care after discharge.
The main questions it aims to answer are:
Does the RESET program reduce postoperative complications, prolonged hospitalizations, and unplanned rehospitalizations after oncological and non-oncological surgery?
Does the RESET program improve patients' overall health status, physical function, quality of life, perioperative safety, and recovery?
Does implementation of RESET improve the organization and efficiency of hospital care while reducing healthcare resource utilization and costs?
Researchers will compare patients receiving the RESET program with patients receiving standard perioperative care to determine whether the comprehensive intervention leads to improved clinical, organizational, and patient-reported outcomes.
Participants assigned to the RESET intervention will:
undergo a comprehensive multidisciplinary prehabilitation assessment performed by a physician, physiotherapist, dietitian, psychologist, clinical pharmacist, nurse, and study coordinator;
receive an individualized prehabilitation program that may include physical exercise, nutritional support, psychological support, medication optimization, and patient education before surgery;
use a dedicated RESET mobile application to communicate with the multidisciplinary prehabilitation team, ask questions, receive individualized recommendations and information, follow the schedule of visits and planned activities, and support adherence to the intervention;
undergo reassessment of their health status, needs, and implementation of recommendations on the day of hospital admission, allowing barriers to be identified and the perioperative care plan to be optimized;
receive standardized in-hospital perioperative care incorporating Enhanced Recovery After Surgery principles, the SAFER Patient Flow Bundle, the Red2Green methodology, medication review by a clinical pharmacist, and coordinated multidisciplinary care;
receive an individualized transitional care plan after discharge, including follow-up support and monitoring for complications and rehospitalization.
Participants in the control group will receive standard perioperative care according to routine clinical practice at the participating hospitals.
The study will evaluate clinical outcomes, including postoperative complications, prolonged hospitalization, rehospitalization, recovery, overall health status, physical function, and quality of life. It will also evaluate patient satisfaction, adherence to the RESET pathway, organizational effectiveness, and costs associated with implementation of RESET.
The results are expected to support the development of an evidence-based and scalable perioperative care model that can be used in oncological surgery and in older patients undergoing major non-oncological surgery.
ONCOLOGY GROUP
Inclusion Criteria:
Exclusion Criteria:
NON-ONCOLOGY GROUP
Inclusion Criteria:
Exclusion Criteria:
- Diagnosis of cancer
natalia.jedruchniewicz@wssk.wroc.pl
Because of the multidisciplinary behavioural nature of the RESET intervention, complete blinding is not feasible. Participants are informed about study participation and undergo identical assessments, questionnaires, and wearable monitoring regardless of allocation; however, they are not informed whether they receive the individualized RESET intervention or standard perioperative care. Members of the prehabilitation team are aware of treatment allocation to deliver personalized recommendations. Healthcare professionals responsible for inpatient perioperative management and assessment of postoperative clinical outcomes are not routinely informed of participants' group allocation. Primary outcomes consist predominantly of objective clinical endpoints, and analyses will be conducted according to a pre-specified statistical analysis plan.
Participants receive the comprehensive RESET perioperative care pathway, including individualized multidisciplinary prehabilitation, structured perioperative management, enhanced recovery principles, coordinated discharge planning, transitional care, and follow-up using the RESET digital platform. The intervention is tailored to individual patient needs while following standardized study procedures. Both oncology and elderly (non-oncology) participants may be allocated to this arm.
Participants receive standard perioperative care according to routine institutional practice without the coordinated RESET programme. Standard care may include selected supportive interventions if clinically indicated but does not include the structured multidisciplinary RESET pathway. Both oncology and elderly (non-oncology) participants may be allocated to this arm.
natalia.jedruchniewicz@wssk.wroc.pl+48713270538
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