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

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.

• Length of index hospital stay in calendar days [Срок оценки: From the date of index hospital admission until the date of hospital discharge, assessed up to 90 days after admission]
• Change in overall health status [Срок оценки: Baseline at 21 ± 7 days before surgery, at index hospital admission before surgery following the preoperative intervention, and at 30 ± 5 days after hospital discharge]
• Patient satisfaction [Срок оценки: At the summary prehabilitation visit on the day 1 of hospital admission]
• Compliance with the prehabilitation protocol [Срок оценки: From the baseline prehabilitation visit, scheduled 21 ± 7 days before surgery, through hospital admission for surgery]
• Effectiveness of Stochastic Organizational Support Network Planning [Срок оценки: From the baseline prehabilitation visit, scheduled 21 ± 7 days before surgery, through hospital admission for surgery]
• Direct healthcare costs [Срок оценки: From the baseline prehabilitation visit through 30 days after discharge from the index hospitalization]