Comprehensive Tool to Improve the Quality and Optimize Hospitalization of Oncological Surgery Patients Implemented for Timely, Safe Discharge From Hospital - Ready for Safe Cancer Treatment RESET, Consisting of a Standardized Sequence of Processes -From Prehabilitation, Therapeutic Team/Patient/Family Advanced Communication, Early Rehabilitation Protocol, Followed by Individual Transitional Care Program, Dedicated to Oncology Network Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12,800
- 试验地点
- 2
- 主要终点
- Number of participants with prolonged index hospitalization lasting 14 calendar days or longer
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of participants with prolonged index hospitalization lasting 14 calendar days or longer
时间窗: 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
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.
Number of participants with an unplanned hospital readmission within 30 days after index hospital discharge
时间窗: 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.
Participants with at least one postoperative complication within 30 days after index surgery
时间窗: From completion of index surgery through postoperative day 30
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.
次要结局
- 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)
- Direct healthcare costs(From the baseline prehabilitation visit through 30 days after discharge from the index hospitalization)