Gastric Cancer, Prehabilitation
Conditions
Keywords
gastric cancer, prehabilitation
Brief summary
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.
Detailed description
The main questions it aims to answer are: Does digital multi-modal prehabilitation reduce the postoperative comprehensive complication index (CCI) compared to conventional care? Does the intervention improve perioperative functional capacity (e.g., 6-minute walk distance, cardiopulmonary function), nutritional status, psychological well-being, chemotherapy adherence, and long-term survival outcomes (3-year overall and disease-free survival)? Researchers will compare the experimental group (receiving at least 2 weeks of 5G+AI digitally supervised home-based multi-modal prehabilitation plus standard ERAS perioperative management) to the control group (receiving conventional management plus standard ERAS perioperative management) in a 1:1 randomization to see if the digital prehabilitation approach significantly lowers postoperative complications, enhances functional reserve, improves nutritional and psychological status, and optimizes recovery and survival.
Interventions
BEHAVIORALmHealth prehabilitation group
receiving at least 4 weeks of 5G+AI digitally supervised home-based multi-modal prehabilitation plus standard ERAS perioperative management
OTHERERAS 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.
Sponsors
The Affiliated Hospital of Qingdao University
People's Hospital of Xinjiang Uygur Autonomous Region
First Affiliated Hospital, Sun Yat-Sen University
Sixth Affiliated Hospital, Sun Yat-sen University
Shandong Provincial Hospital
The Second Hospital of Shandong University
Yantai Yuhuangding Hospital
The Affiliated Hospital of Shandong Second Medical University
Weifang People's Hospital
Shandong Cancer Hospital and Institute
Dongying People's Hospital
Rizhao People's Hospital
Jining First People's Hospital
Peking University Cancer Hospital (Inner Mongolia Campus)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complications | postoperative 30 days | comprehensive complication index (CCI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| six minute walk test (6MWT) | Baseline, before surgery | The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines. |
| Oncological outcomes | 3 years after surgery | 3-year recurrence-free survival and 3-year overall survival |
| psychological states | Baseline, Before surgery | Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms. |
| Quality of life - EORTC QLQ-C30 | Baseline, Before surgery | For the functional scale and the overall quality of life scale, the higher the score, the better the function or quality of life; for the symptom scale/items, the higher the score, the more severe the symptoms or problems. The comprehensive score of QLQ-C30 is calculated based on the average of the scores of the 13 domains of the QLQ-C30 scale (excluding overall life quality and economic impact). The higher the score, the better the health-related quality of life. |
| Quality of life-EORTC QLQ-STO22 | Baseline, Before surgery | Gastric cancer-specific quality of life assessed using the EORTC Quality of Life Questionnaire - Stomach Cancer Module (EORTC QLQ-STO22). The questionnaire includes five multi-item scales (dysphagia, pain, reflux, eating restrictions, anxiety) and four single items (dry mouth, body image, taste problems, hair loss). Higher scores indicate more severe symptoms. |
| Prognostic Nutritional Index (PNI) | baseline, piror to surgery | The Prognostic Nutritional Index (PNI) is calculated based on serum albumin and lymphocyte count. The formula is: PNI = Serum albumin (g/dL) × 10 + Lymphocyte count (×10⁹/L) × 0.005. ≥45: Low risk, with good nutritional and immune status; 35-44: Medium risk, there may be mild malnutrition or immunosuppression; \<35: High risk, indicating severe malnutrition or impaired immune function. |
| postoperative hospital stay | Postoperative 30 days | — |
Contacts
CONTACTYulong Tian
CONTACTYanbing Zhou
PRINCIPAL_INVESTIGATORYanbing Zhou
The Affiliated Hospital of Qingdao University
Outcome results
None listed