Home-based Whole Course Multimodal Prehabilitation Based on 5G + Artificial Intelligence Mobile Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Affiliated Hospital of Qingdao University

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

328 Participants
are divided into 2 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