Preoperative Home-based 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 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.

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

Surgery is planned after neoadjuvant therapy

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

490 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

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