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

Summary

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.

Conditions

• Neoplasms
• Frailty
• Surgical Procedures, Operative

Interventions

OTHER

RESET multimodal perioperative care pathway

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.

OTHER

Standard perioperative care

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.

Sponsors & Collaborators

• Łukasiewicz Research Network - PORT Polish Center for Technology Development

  collaborator UNKNOWN

• 4th Military Clinical Hospital with Polyclinic, Poland

  collaborator OTHER

• Regional Specialist Hospital in Wroclaw

  lead OTHER

Principal Investigators

• Małgorzata Wierzbicka, Professor · Regional Specialist Hospital in Wroclaw

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-16

Primary Completion

2030-05-16

Completion

2031-07-31

Countries

• Poland

Study Locations