Ready for Safe Cancer Treatment (RESET): A Comprehensive Perioperative Program for Surgical Oncology

Sponsor
Regional Specialist Hospital in Wroclaw
Study ID
NCT07727876
Status
Recruiting
Apply to this trial

Conditions

  • Frailty
  • Neoplasms
  • Surgical Procedures, Operative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RESET multimodal perioperative care pathway — OTHER
    RESET is a standardized, individualized, multidisciplinary perioperative care pathway delivered from approximately 21±7 days before surgery through 30-day follow-up. It includes: (1) preoperative assessment and personalized prehabilitation addressing nutrition, physical activity, psychological support, and medication optimization; (2) care coordination and communication with the prehabilitation team, supported by the RESET mobile application; (3) reassessment on hospital admission and coordinated perioperative planning; (4) enhanced recovery during hospitalization, including early mobilization, nutritional support, pain management, the SAFER Patient Flow Bundle, and Red-to-Green review; and (5) individualized discharge planning and transitional care. Components are tailored to the participant's clinical status, functional capacity, nutritional and psychological needs, comorbidities, and planned surgery.
  • Standard perioperative care — OTHER
    Participants receive standard perioperative care according to routine practice at the participating hospital. This includes usual surgical and anesthetic qualification, preoperative tests and consultations when clinically indicated, routine inpatient surgical and postoperative care, discharge instructions, and standard follow-up. Participants do not receive the coordinated multidisciplinary RESET pathway or individualized RESET recommendations. Protocol-defined assessments and activity monitoring are performed in both study arms for research purposes and are not components of the comparator intervention.

Study Details

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 Dates

First listed
Jul 27, 2026
Start date
Feb 16, 2026
Status verified
Jul 2026
Primary completion
May 16, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
12,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: RESET Intervention
    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.
  • Active Comparator: Standard Perioperative Care
    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.

Primary Outcome Measure

Number of participants with prolonged index hospitalization lasting 14 calendar days or longer [ Time Frame: From the date of index hospital admission until the date of hospital discharge; prolonged hospitalization is determined when the index hospital stay reaches at least 14 calendar days, assessed up to 90 days after admission ]

Central Contacts

Related Studies