Preoperative Multi-mode Prehabilitation Management for Neoadjuvant Chemotherapy Gastric Cancer Patients Supervised at Home Based on 5G + AI Mobile Health (mHealth): A Multicenter RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 490
- 主要终点
- postoperative complications
研究概览
简要总结
The goal of this prospective, multicenter, open-label randomized controlled clinical trial is to evaluate whether a home-based, digitally supervised multi-modal prehabilitation intervention can improve functional capacity, treatment tolerance, and short- and long-term clinical outcomes in gastric cancer patients who have completed 2-4 cycles of neoadjuvant chemotherapy and are scheduled for radical gastrectomy.
详细描述
The main questions it aims to answer are: Does digital multi-modal prehabilitation reduce the postoperative comprehensive complication index (CCI) compared to conventional care? Does the intervention improve perioperative functional capacity (e.g., 6-minute walk distance, cardiopulmonary function), nutritional status, psychological well-being, chemotherapy adherence, and long-term survival outcomes (3-year overall and disease-free survival)? Researchers will compare the experimental group (receiving at least 2 weeks of 5G+AI digitally supervised home-based multi-modal prehabilitation plus standard ERAS perioperative management) to the control group (receiving conventional management plus standard ERAS perioperative management) in a 1:1 randomization to see if the digital prehabilitation approach significantly lowers postoperative complications, enhances functional reserve, improves nutritional and psychological status, and optimizes recovery and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Surgery is planned after 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 preoperative multimodal prehabilitation combined with ERAS before gastrectomy.
干预措施: mHealth prehabilitation group (Behavioral)
ERAS group
The ERAS group patients will be managed according to the ERAS pathway.
干预措施: ERAS group (Other)
结局指标
主要结局
postoperative complications
时间窗: postoperative 30 days
comprehensive complication index (CCI)
次要结局
- six minute walk test (6MWT)(Baseline, before surgery)
- Oncological outcomes(3 years after surgery)
- psychological states(Baseline, Before surgery)
- Quality of life - EORTC QLQ-C30(Baseline, Before surgery)
- Quality of life-EORTC QLQ-STO22(Baseline, Before surgery)
- Prognostic Nutritional Index (PNI)(baseline, piror to surgery)
- postoperative hospital stay(Postoperative 30 days)
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