Clinical trial · Interventional
Preoperative Home-based Multimodal Prehabilitation Based on 5G + Artificial Intelligence Mobile Health
Preoperative Multi-mode Prehabilitation Management for Neoadjuvant Chemotherapy Gastric Cancer Patients Supervised at Home Based on 5G + AI Mobile Health (mHealth): A Multicenter RCT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Prehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS group | Other | — | UNRESOLVED |
| mHealth prehabilitation group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- prehabilitation group
- description
- The prehabilitation group will receive preoperative multimodal prehabilitation combined with ERAS before gastrectomy.
- interventionNames
- Behavioral: mHealth prehabilitation group
- type
- PLACEBO_COMPARATOR
- label
- ERAS group
- description
- The ERAS group patients will be managed according to the ERAS pathway.
- interventionNames
- Other: ERAS group
Primary outcomes (1)
- measure
- postoperative complications
- timeFrame
- postoperative 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Surgery is planned after 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)
References
Publications (0)
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