Whole-course Multi-modal Prehabilitation Management for Neoadjuvant Chemotherapy Gastric Cancer Patients Supervised at Home-based on 5G + AI Mobile Health (mHealth): a Multicenter Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Comprehensive complication index (CCI)
研究概览
简要总结
The whole course management of gastric caner patients receiving neoadjuvant therapy frequently hinders by challenges such as inaccurate exercise plans, inadequate nutritional supplementary, limited access to timely psychological support, the toxicity of chemtherapy and poor adherence to prehabilitation protocols. AI (Agent Intelligence) have already been demonstrated remarkable capabilities in personalized patient education and improving compliance to perhabilitation protocols. To date, high quality evidence from randomized clinical trials investigating the clinical and oncological benefit of prehabilitation based on 5G+AI mobile health for this patient cohort is lacking.
详细描述
The goal of this clinical trial is to achieve real-time, dynamic and individualized comprehensive pre-rehabilitation management for patients undergoing neoadjuvant treatment for gastric cancer at home through a 5G remote medical network and a digital system based on artificial intelligence algorithms. Patients who meet the inclusion criteria will be randomly allocated to prehabilitation group or usual group. Both groups will receive the perioperative management following the Enhanced Recovery After Surgery (ERAS) guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Aged 18 years or older
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Histologically confirmation of gastric or gastroesophageal junction (GEJ) adenocarcinoma. For GEJ carcinomas, eligibility is strictly confined to those presenting with Siewert type III tumors or Siewert type II tumors that do not mandate a concurrent thoracotomy
- •Multidisciplinary team (MDT) referral for neoadjuvant chemotherapy prior to gastrectomy
- •For female participants of childbearing potential, a negative serum pregnancy test must be confirmed within 7 days prior to the initial administration of neoadjuvant therapy
- •Capacity to comprehend and voluntarily sign a written informed consent form
- •Ability to use digital technology (e.g., smart phones, wearable devices) independently or with the assistance of family members
排除标准
- •Distant metastasis
- •Severe cardiac dysfunction (preoperative LVEF < 30% or NYHA classification IV), severe liver dysfunction (Child-Pugh C grade), severe kidney dysfunction (preoperative CRRT was received), ASA grade IV or above; 6MWD ≤ 250 meters
- •Within 6 months before enrollment, the patient had experienced cerebral hemorrhage, cerebral infarction, TIA, or suffered from central nervous system diseases or mental disorders, and was unable to cooperate in completing neoadjuvant therapy and prehabilitation
- •Presence of severe systemic infections (e.g., multiple organ dysfunction syndrome [MODS]) or active infectious diseases (e.g., tuberculosis)
- •Emergency surgery is required due to complications of the tumor (e.g. bleeding, perforation, obstruction)
- •Simultaneous tumors or other diseases requiring simultaneous surgery (excluding laparoscopic cholecystectomy)
- •Patients who are participating in any other clinical trials (except observational, non-interventional clinical study)
研究组 & 干预措施
prehabilitation group
The prehabilitation group will receive multimodal prehabilitation combined with ERAS before gastrectomy.
干预措施: mHealth prehabilitation group (Behavioral)
prehabilitation group
The prehabilitation group will receive multimodal prehabilitation combined with ERAS before gastrectomy.
干预措施: ERAS group (Behavioral)
ERAS group
The ERAS group patients will be managed according to the ERAS pathway.
干预措施: ERAS group (Behavioral)
结局指标
主要结局
Comprehensive complication index (CCI)
时间窗: postoperative 30 days
Based on the Clavien-Dindo Classification the comprehensive complication index (CCI) captures any complication that occurrs after an intervention. The CCI was derived from these scores using the CCI calculator available online (http://www.assessurgery.com). The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death) providing a clear picture of the cumulative impact of complications on patient well-being.
次要结局
- psychological states(Baseline, 4 weeks prior to surgery, 3 days prior to surgery)
- 6 minutes walking test(Baseline, 4 weeks prior to surgery, 3 days prior to surgery)
- The proportion of neoadjuvant therapy completed as planned(4 weeks prior to surgery)
- postoperative hospital stay(Postoperative 30 days)
- Prognostic Nutritional Index (PNI)(Baseline, 4 weeks prior to surgery, 3 days prior to surgery)
- Quality of life-EORTC QLQ-STO22(Baseline, 4 weeks prior to surgery, 3 days prior to surgery)
- Quality of life - EORTC QLQ-C30(Baseline, 4 weeks prior to surgery, 3 days prior to surgery)
- Adherence to the prehabilitation plan(1 days prior to surgery)
- Oncological outcomes(3 years)
- Body weight(Baseline, 4 weeks prior to surgery, 3 days prior to surgery)
- Inflammatory indicators-white blood cell count, neutrophil count, lymphocyte count, monocyte count, platelet count(Baseline, 4 weeks prior to surgery, 3 days prior to surgery, and postoperative days 1, 3, and 5)
- Nutritional status-hemoglobin, albumin, prealbumin levels(Baseline, 4 weeks prior to surgery, 3 days prior to surgery, and postoperative days 1, 3, and 5)
研究者
Zhou Yanbing
The Director of the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University
The Affiliated Hospital of Qingdao University