About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- mHealth prehabilitation group
- ERAS group
Treatment groups
Sponsors and collaborators
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