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.
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
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)
Parallel
mHealth prehabilitation group
Behavioralreceiving at least 4 weeks of 5G+AI digitally supervised home-based multi-modal prehabilitation plus standard ERAS perioperative management
ERAS group
Other interventionThe management of ERAS group was carried out in accordance with the standard ERAS protocol from admission until 30 days postdischarge. The ERAS program mainly included malnutrition screening, health education, surgical risk assessment, and smoking and drinking cessation.
postoperative complications
comprehensive complication index (CCI)
six minute walk test (6MWT)
The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.
Oncological outcomes
3-year recurrence-free survival and 3-year overall survival
psychological states
Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms.
Quality of life - EORTC QLQ-C30
For the functional scale and the overall quality of life scale, the higher the score, the better the function or quality of life; for the symptom scale/items, the higher the score, the more severe the symptoms or problems. The comprehensive score of QLQ-C30 is calculated based on the average of the scores of the 13 domains of the QLQ-C30 scale (excluding overall life quality and economic impact). The higher the score, the better the health-related quality of life.
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The Affiliated Hospital of Qingdao University
Lead sponsor
People's Hospital of Xinjiang Uygur Autonomous Region
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
Shandong Provincial Hospital
Collaborator
The Second Hospital of Shandong University
Collaborator
Yantai Yuhuangding Hospital
Collaborator
The Affiliated Hospital of Shandong Second Medical University
Collaborator
Weifang People's Hospital
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Dongying People's Hospital
Collaborator
Rizhao People's Hospital
Collaborator
Jining First People's Hospital
Collaborator
Peking University Cancer Hospital (Inner Mongolia Campus)
Collaborator
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