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

NCT07764523 · tracked via the Priya Life Science China tracker

Sponsor

The Affiliated Hospital of Qingdao University

Phase

Not applicable

Started

2026-08-01

Last updated

2026-08-14

Condition(s) studied

Gastric CancerPrehabilitation

Investigational drug(s) / intervention(s)

mHealth prehabilitation groupERAS group

mHealth prehabilitation group: Participants 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: The 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.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 * For female participants of childbearing potential, a negative serum pregnancy test must be confirmed within 7 days prior to the initial administration of neoadjuvant therapy * Capacity to comprehend and voluntarily sign a written informed consent form * Ability to use digital technology (e.g., smart phones, wearable devices) independently or with the assistance of family members Exclusion Criteria: * 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) * Emergency surgery is required due to complications of the tumor (e.g. bleeding, perforation, obstruction) * Simultaneous tumors or other diseases requiring simultaneous surgery (excluding laparoscopic cholecystectomy) * Patients who are participating in any other clinical trials (except observational, non-interventional clinical study)

Primary outcome measure(s)

Comprehensive complication index (CCI) — postoperative 30 days
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.

Trial sites (1)

Facility	City	Region	Status
the Affiliated Hospital of QIngdao University	Qingdao	Shandong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07764523 on ClinicalTrials.gov ↗ ← All trials in China