Ready for Safe Cancer Treatment (RESET): A Comprehensive Perioperative Program for Surgical Oncology
Recruiting now · Not applicable
Conditions studied: Neoplasms, Frailty, Surgical Procedures, Operative
In brief
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.
Key facts
- Study ID
- NCT07727876
- Run by
- Regional Specialist Hospital in Wroclaw
- People needed
- 12800
- Starts
- 2026-02-16
- Expected to finish
- 2031-07-31
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Qualification for admission to surgical departments with an ICD10 diagnosis for radical cancer surgery
- Preliminary qualification for one of the procedures listed in Section II.B.23
- Informed consent to participate in the study
You may not qualify if…
- Age < 18 years
- Qualification for admission to surgical departments with an ICD10 diagnosis for diagnostic procedures to identify cancer
- Pregnancy or breastfeeding
- NON-ONCOLOGY GROUP
- Inclusion Criteria:
- Informed consent to participate in the study
- Age ≥ 70 years
- All consecutive patients referred for planned non-oncological surgical procedures, not solely diagnostic, performed under general anesthesia
- Exclusion Criteria:
- Diagnosis of cancer
Where it is running
- 4th Military Clinical Hospital in Wroclaw — Wroclaw, Lower Silesian Voivodeship, Poland (enrolling)
- Regional Specialist Hospital in Wrocław — Wroclaw, Lower Silesian Voivodeship, Poland (enrolling)
Full record on ClinicalTrials.gov
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