Ready for Safe Cancer Treatment (RESET): A Comprehensive Perioperative Program for Surgical Oncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegional Specialist Hospital in Wroclaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years
Qualification for admission to surgical departments with an ICD10 diagnosis for diagnostic procedures to identify cancer
Pregnancy or breastfeeding
Informed consent to participate in the study
Trial design
Design model
Parallel
Treatments tested in this trial
RESET multimodal perioperative care pathway
Other interventionRESET 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 interventionParticipants 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.
Treatment groups
12,800 Participants
are divided into 2 treatment groupsGroup A: RESET InterventionExperimental treatment 1 intervention
Group B: Standard Perioperative CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 admission2
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.
Time frame
30 days after index hospital discharge3
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.
Time frame
From completion of index surgery through postoperative day 30Secondary outcomes
1
Length of index hospital stay in calendar days
Length of index hospital stay will be measured in calendar days from admission for the index surgical hospitalization to hospital discharge. The primary analysis of this secondary outcome will include all randomized participants, including participants who experience postoperative complications. Length of stay will be compared between the RESET intervention arm and the standard-care control arm.
Time frame
From the date of index hospital admission until the date of hospital discharge, assessed up to 90 days after admission2
Change in overall health status
Overall health status will be assessed as a multidomain secondary outcome using protocol-defined measures: patient-reported and clinical scale scores, including SF-36 and HADS; laboratory parameters and measures of allostatic load; physical function tests, including the 6-minute walk test, handgrip strength measured by dynamometry, FEV1, and the sit-to-stand test; and anthropometric and nutritional measures, including BMI, waist-to-hip ratio, and body composition assessed by bioelectrical impedance analysis. Each component will be recorded and analyzed separately using its validated score or original measurement unit. Changes from baseline to the post-prehabilitation assessment at index hospital admission and to the follow-up visit 30 ± 5 days after discharge will be calculated and compared between the RESET intervention and standard-care control arms. Results will be interpreted according to the scoring rules, units, and direction of change applicable to each measure.
Time frame
Baseline at 21 ± 7 days before surgery, at index hospital admission before surgery following the preoperative intervention, and at 30 ± 5 days after hospital discharge3
Patient satisfaction
Patient satisfaction will be assessed using the dedicated study-specific patient satisfaction questionnaire. The questionnaire will evaluate the participant's experience with the prehabilitation program and the care provided within the RESET pathway.
Time frame
At the summary prehabilitation visit on the day 1 of hospital admission4
Compliance with the prehabilitation protocol
Compliance with the individualized prehabilitation protocol will be monitored using data collected from the activity-monitoring wristband, the dedicated mobile application, and follow-up assessments. Compliance data will be used to evaluate the extent to which participants followed the prehabilitation recommendations provided by the multidisciplinary team.
Time frame
From the baseline prehabilitation visit, scheduled 21 ± 7 days before surgery, through hospital admission for surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Regional Specialist Hospital in Wroclaw
Lead sponsor
Łukasiewicz Research Network - PORT Polish Center for Technology Development
Collaborator
4th Military Clinical Hospital with Polyclinic, Poland
Collaborator
Source ClinicalTrials.gov