Ready for Safe Cancer Treatment (RESET): A Comprehensive Perioperative Program for Surgical Oncology (RESET)
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
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Natalia Jędruchniewicz, PhD
- 전화번호: +48713270538
- 이메일: natalia.jedruchniewicz@wssk.wroc.pl
연구 장소
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, 폴란드, 50-981
- 모병
- 4th Military Clinical Hospital in Wroclaw
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연락하다:
- Anna Skotny, PhD
- 전화번호: (+48) 71 727 41 46
- 이메일: cwbk@4wsk.pl
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Wroclaw, Lower Silesian Voivodeship, 폴란드, 51-124
- 모병
- Regional Specialist Hospital in Wrocław
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연락하다:
- Natalia Jędruchniewicz, PhD
- 전화번호: +48713270538
- 이메일: natalia.jedruchniewicz@wssk.wroc.pl
-
수석 연구원:
- Małgorzata Wierzbicka, Professor
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: RESET Intervention
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.
|
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.
|
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활성 비교기: Standard Perioperative Care
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.
|
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with prolonged index hospitalization lasting 14 calendar days or longer
기간: 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
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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.
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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
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Number of participants with an unplanned hospital readmission within 30 days after index hospital discharge
기간: 30 days after index hospital discharge
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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.
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30 days after index hospital discharge
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Participants with at least one postoperative complication within 30 days after index surgery
기간: From completion of index surgery through postoperative day 30
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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.
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From completion of index surgery through postoperative day 30
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of index hospital stay in calendar days
기간: From the date of index hospital admission until the date of hospital discharge, assessed up to 90 days after admission
|
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.
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From the date of index hospital admission until the date of hospital discharge, assessed up to 90 days after admission
|
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Change in overall health status
기간: 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
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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.
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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
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Patient satisfaction
기간: At the summary prehabilitation visit on the day 1 of hospital admission
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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.
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At the summary prehabilitation visit on the day 1 of hospital admission
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Compliance with the prehabilitation protocol
기간: From the baseline prehabilitation visit, scheduled 21 ± 7 days before surgery, through hospital admission for surgery
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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.
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From the baseline prehabilitation visit, scheduled 21 ± 7 days before surgery, through hospital admission for surgery
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Effectiveness of Stochastic Organizational Support Network Planning
기간: From the baseline prehabilitation visit, scheduled 21 ± 7 days before surgery, through hospital admission for surgery
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The effectiveness of Stochastic Organizational Support Network Planning (SOSNP) will be evaluated based on the number of interventions performed within the SOSNP and participant waiting times for the required specialist consultations.
Waiting times within the SOSNP will be compared with the average waiting times for corresponding specialist consultations in the standard Polish National Health Fund system.
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From the baseline prehabilitation visit, scheduled 21 ± 7 days before surgery, through hospital admission for surgery
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Direct healthcare costs
기간: From the baseline prehabilitation visit through 30 days after discharge from the index hospitalization
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Costs associated with RESET will be evaluated based on the costs of prehabilitation, index hospitalization, rehabilitation, postoperative follow-up visits, prolonged hospitalization, and hospital readmission.
Financial effectiveness indicators will also be assessed.
Costs will be compared between participants assigned to the RESET intervention arm and participants assigned to the standard-care control arm.
|
From the baseline prehabilitation visit through 30 days after discharge from the index hospitalization
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Małgorzata Wierzbicka, Professor, Regional Specialist Hospital in Wroclaw
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024/ABM/02/00051 (기타 보조금/기금 번호: Medical Research Agency)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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