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.
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
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
BehavioralParticipants allocated to the intervention group will receive a whole-course, remotely supervised, home-based multimodal prehabilitation programme delivered through a 5G- and artificial intelligence (AI)-enabled digital health platform. The multimodal prehabilitation included physical and respiratory training, nutritional support, and psychosocial treatment. Our center's prehabilitation experts, clinical nutritionists, psychiatrists, surgeons, nurses and oncologists will collaboratively assess and develop prehabilitation plans. The prehabilitation group received a mobile mini-app that provided an exercise program, dietary advice and psychological assessment and intervention. The management of prehabilitation 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.
ERAS group
BehavioralThe 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.
Comprehensive complication index (CCI)
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.
psychological states
Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms.
6 minutes walking test
The 6-minute walking test (6MWT) can be used to measure physical capacity to reflect cardiopulmonary function. The test involves walking as quickly as possible for six minutes in a quiet, flat corridor of 15m length, with distance recorded. Each patient will perform two tests, one hour apart, with the longer distance used for data analysis.
The proportion of neoadjuvant therapy completed as planned
postoperative hospital stay
Click on the lead sponsor to view all of their trials.
The Affiliated Hospital of Qingdao University
Lead sponsor
Peking University Cancer Hospital (Inner Mongolia Campus)
Collaborator
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
This trial is not recruiting at the moment. You can still explore other options:
