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

NCT07727876 | Recruiting

• 1 other identifier: 2024/ABM/02/00051
• Study Type: interventional
• Target: 12,800
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

prehabilitation; perioperative care; surgical oncology; enhanced recovery after surgery; transitional care; hospital discharge; multidisciplinary care; postoperative complications; rehospitalization; prolonged hospitalization; patient flow; frailty; geriatric surgery; cancer surgery; supportive care

Outcome Measures

Primary Outcomes (3)

• Number of participants with prolonged index hospitalization lasting 14 calendar days or longer

  Prolonged index hospitalization is defined as a hospital stay lasting 14 calendar days or longer, calculated from admission for the index surgical hospitalization to hospital discharge. The outcome will be reported as the number and percentage of participants meeting this definition in each study arm.

  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

• Number of participants with an unplanned hospital readmission within 30 days after index hospital discharge

  An unplanned hospital readmission is defined as an unplanned admission to the same or another hospital within 30 days after discharge from the index hospitalization. Readmissions will be identified using hospital electronic health records, hospital information systems, and participant follow-up interviews. The outcome will be reported as the number and percentage of participants with at least one unplanned readmission.

  30 days after index hospital discharge

• Participants with at least one postoperative complication within 30 days after index surgery

  Postoperative complications occurring after the index surgical procedure will be identified and graded according to the Clavien-Dindo classification. The outcome will be reported as the number and percentage of participants with at least one Clavien-Dindo grade I-V complication within 30 days after index surgery. For participants with multiple postoperative complications, the highest Clavien-Dindo grade observed during this period will also be recorded.

  From completion of index surgery through postoperative day 30

Secondary Outcomes (6)

• Length of index hospital stay in calendar days

  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

  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

  At the summary prehabilitation visit on the day 1 of hospital admission

• Compliance with the prehabilitation protocol

  From the baseline prehabilitation visit, scheduled 21 ± 7 days before surgery, through hospital admission for surgery

• Effectiveness of Stochastic Organizational Support Network Planning

  From the baseline prehabilitation visit, scheduled 21 ± 7 days before surgery, through hospital admission for surgery

Study Arms (2)

RESET Intervention

EXPERIMENTAL

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.

Other: RESET multimodal perioperative care pathway

Standard Perioperative Care

ACTIVE COMPARATOR

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.

Other: Standard perioperative care

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.

RESET Intervention

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.

Standard Perioperative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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
• \- Diagnosis of cancer

Sponsors & Collaborators

• Regional Specialist Hospital in Wroclaw: lead
• Łukasiewicz Research Network - PORT Polish Center for Technology Development: collaborator
• 4th Military Clinical Hospital with Polyclinic, Poland: collaborator

Study Sites (2)

4th Military Clinical Hospital in Wroclaw

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

RECRUITING

Regional Specialist Hospital in Wrocław

Wroclaw, Lower Silesian Voivodeship, 51-124, Poland

RECRUITING

Related Publications (1)

• Wierzbicka M, Kiszka M, Barnas S, Jeziorny M, Zajac B, Dwornikowska-Dabrowska M, Jedruchniewicz N. The Ready for Safe Cancer Treatment (RESET) tool: enhancing quality and optimizing timely and safe discharge with transitional care adjustments for Head and Neck Cancer patients. Otolaryngol Pol. 2025 Mar 14;79(3):1-7. doi: 10.5604/01.3001.0055.0006.

  PMID: 40084835 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Frailty; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Małgorzata Wierzbicka, Professor

  Regional Specialist Hospital in Wroclaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Jędruchniewicz, PhD

CONTACT

+48713270538; natalia.jedruchniewicz@wssk.wroc.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Because of the multidisciplinary behavioural nature of the RESET intervention, complete blinding is not feasible. Participants are informed about study participation and undergo identical assessments, questionnaires, and wearable monitoring regardless of allocation; however, they are not informed whether they receive the individualized RESET intervention or standard perioperative care. Members of the prehabilitation team are aware of treatment allocation to deliver personalized recommendations. Healthcare professionals responsible for inpatient perioperative management and assessment of postoperative clinical outcomes are not routinely informed of participants' group allocation. Primary outcomes consist predominantly of objective clinical endpoints, and analyses will be conducted according to a pre-specified statistical analysis plan.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, parallel-group randomized controlled trial evaluating the RESET programme versus standard perioperative care. Participants are randomized in a 9:1 ratio to receive either the multidisciplinary RESET intervention or routine care according to local clinical practice. The study includes two predefined patient populations: patients undergoing oncological surgery and elderly patients undergoing major non-oncological surgery. Both populations are randomized using the same study design and intervention strategy, with predefined subgroup analyses planned for each population. Randomization is performed centrally using a web-based dynamic allocation (biased-coin) procedure. Participants remain in their assigned study arm throughout the study without crossover.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 27, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): May 16, 2030
• Study Completion (Estimated): July 31, 2031
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Beginning after publication of the primary study results and available upon request for the remainder of the 20-year study data-retention period.
• Access Criteria: Access will be considered for qualified researchers who submit a methodologically sound research proposal describing the objectives, requested data, planned analyses, and data-protection arrangements. Requests will be reviewed by the Sponsor and Principal Investigator. Data will be provided only for the approved purpose following execution of a data-use agreement. Attempts to identify or re-identify study participants will be prohibited.

Locations

PL (2)