Overview
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.
Description
RESET is a prospective, two-center, two-arm, parallel-group randomized controlled study evaluating a comprehensive perioperative care pathway in two surgical populations.
The oncology population includes adults aged 18 years or older who are qualified for planned oncological surgery that is not solely diagnostic. The non-oncology population includes patients aged 70 years or older who are qualified for planned non-oncological surgery, not solely diagnostic, performed under general anesthesia.
After providing written informed consent and meeting the eligibility criteria, participants from both populations will be randomly assigned in a 9:1 ratio to either the RESET intervention arm or the standard-care control arm. Participants in both populations follow the same general study pathway, with individual procedures and recommendations adapted to their clinical condition, age, type of surgery, functional capacity, and identified needs.
The RESET intervention covers the complete perioperative pathway, beginning with preoperative preparation and continuing through hospitalization, postoperative recovery, discharge planning, and follow-up. The program is organized into four interconnected modules: prehabilitation, hospitalization and discharge planning, postoperative recovery, and transitional care. RESET is evaluated as an integrated, multicomponent care pathway rather than as a set of independently tested interventions.
Module I: Prehabilitation
The first multidisciplinary prehabilitation visit is scheduled approximately 21 ± 7 days before surgery. Participants undergo a comprehensive assessment of their clinical condition, perioperative risk, physical function, nutritional status, psychological status, medication use, comorbidities, and individual support needs.
The assessment is performed by members of the multidisciplinary team, including a physician, physiotherapist, dietitian, psychologist, clinical pharmacist, nurse, and study coordinator. Protocol-defined medical scales, questionnaires, laboratory parameters, physical function tests, and other assessments are used in accordance with the study schedule.
Based on the assessment results, each participant receives an individualized prehabilitation plan. Depending on the needs identified, the plan may include recommendations concerning physical activity and exercise, nutrition, psychological support, medication optimization, management of modifiable risk factors, and education related to the planned surgery and postoperative recovery.
Physical activity is monitored using an activity-monitoring wristband. A dedicated RESET mobile application is used to provide participants with individualized recommendations, general information, schedules of visits and planned activities, and access to communication with the multidisciplinary prehabilitation team. The wristband, application, and follow-up assessments are used to monitor implementation of the prehabilitation recommendations.
When additional specialist input is required, consultations may be organized through Stochastic Organizational Support Network Planning. The number of interventions conducted within this system and waiting times for specialist consultations will be evaluated and compared with average waiting times within the standard National Health Fund system.
A second prehabilitation assessment is conducted on the day of planned hospital admission. The study team evaluates changes in the participant's health status, current medical, nutritional, physical, psychological, and medication-related needs, and implementation of the recommendations provided during the prehabilitation period. Identified barriers and new needs are considered when reviewing the perioperative care plan.
Module II: Hospitalization and discharge planning
During hospitalization, participants receive coordinated multidisciplinary perioperative care. Structured communication is maintained among the therapeutic team, the participant, and, where appropriate and with the participant's involvement, the participant's family or caregiver.
The RESET pathway incorporates Enhanced Recovery After Surgery principles, the SAFER Patient Flow Bundle, the Red2Green methodology, clinical pharmacist involvement, and coordinated assessment of clinical and organizational factors that may affect the course of hospitalization and readiness for discharge.
The treatment schedule, planned surgery, postoperative care, anticipated discharge, and current participant needs are reviewed during hospitalization. Discharge planning begins early and is updated according to the participant's clinical condition and recovery.
Module III: Postoperative recovery
Following surgery, the study team assesses the postoperative course and adapts further care to the participant's clinical condition. Monitoring includes postoperative complications, pain, wound healing, physical recovery, nutritional needs, and readiness for discharge.
Postoperative complications are evaluated according to the study protocol. Early mobilization and rehabilitation are introduced when clinically possible and are adjusted to the participant's previous activity level, current functional capacity, and postoperative condition.
Module IV: Transitional care and follow-up
Before discharge, the participant receives individualized recommendations concerning further treatment, medication use, nutrition, physical activity, rehabilitation, follow-up care, and symptoms requiring contact with healthcare professionals.
The transitional care component is intended to support continuity of care after discharge and the early identification of complications or other needs. Information concerning the course of recovery, postoperative complications, use of healthcare services, and hospital readmissions is collected during follow-up.
The final follow-up assessment is planned approximately 30 days after surgery in accordance with the study schedule. Depending on the applicable protocol procedures and the participant's clinical and organizational circumstances, follow-up may include an on-site visit or telephone contact. Hospital readmissions are assessed during the 30-day period after discharge.
Control arm
Participants assigned to the control arm receive standard perioperative care according to routine clinical practice at the participating hospitals. This includes routine surgical and anesthetic qualification, clinically indicated preoperative tests and consultations, standard inpatient surgical and postoperative care, discharge recommendations, and routine follow-up.
Control-arm participants do not receive the coordinated multidisciplinary RESET pathway, the individualized RESET prehabilitation program, or the RESET transitional care program.
Outcome assessment
The primary endpoints are prolonged hospitalization, hospital readmission, and postoperative complications. Prolonged hospitalization is defined in the study protocol as an index hospital stay lasting at least 14 days. Hospital readmission is evaluated during the 30-day period after discharge.
The secondary endpoints are length of hospital stay, overall health status, patient satisfaction, compliance with the prehabilitation protocol, effectiveness of Stochastic Organizational Support Network Planning, and costs associated with RESET.
Length of hospital stay is measured as the number of days from admission to discharge. In accordance with the predefined secondary endpoint, the comparative assessment of length of stay includes cases without postoperative complications.
Overall health status is evaluated using protocol-defined medical scales, blood parameters, physical function measures, and allostatic load measures. Assessments are conducted before and after the preoperative intervention and during post-discharge follow-up according to the study protocol.
Patient satisfaction is assessed using a dedicated questionnaire. Compliance is monitored using the activity-monitoring wristband, the mobile application, and follow-up assessments.
The effectiveness of Stochastic Organizational Support Network Planning is evaluated using the number of interventions conducted within the system and participant waiting times for specialist consultations, compared with average waiting times in the standard National Health Fund system.
Costs associated with RESET are evaluated through analysis of the costs of prehabilitation, hospitalization, rehabilitation, postoperative follow-up visits, prolonged hospitalization, and rehospitalization, together with financial effectiveness indicators. Costs are compared between the RESET intervention arm and the standard-care control arm.
Eligibility
ONCOLOGY GROUP
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
