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
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