Gastric Cancer, Prehabilitation
Conditions
Keywords
gastric cancer, prehabilitation, mobile health
Brief 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.
Detailed description
The goal of this clinical trial is to achieve real-time, dynamic and individualized comprehensive pre-rehabilitation management for patients undergoing neoadjuvant treatment for gastric cancer at home through a 5G remote medical network and a digital system based on artificial intelligence algorithms. Patients who meet the inclusion criteria will be randomly allocated to prehabilitation group or usual group. Both groups will receive the perioperative management following the Enhanced Recovery After Surgery (ERAS) guidelines.
Interventions
BEHAVIORALmHealth 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.
BEHAVIORALERAS 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
Peking University Cancer Hospital (Inner Mongolia Campus)
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oncological outcomes | 3 years | 3-year recurrence-free survival and 3-year overall survival |
| Body weight | Baseline, 4 weeks prior to surgery, 3 days prior to surgery | — |
| Inflammatory indicators-white blood cell count, neutrophil count, lymphocyte count, monocyte count, platelet count | Baseline, 4 weeks prior to surgery, 3 days prior to surgery, and postoperative days 1, 3, and 5 | Serum levels of inflammatory indicators, including white blood cell count, neutrophil count, lymphocyte count, monocyte count, platelet count are used to assess the inflammatory state. |
| Nutritional status-hemoglobin, albumin, prealbumin levels | Baseline, 4 weeks prior to surgery, 3 days prior to surgery, and postoperative days 1, 3, and 5 | Hemoglobin, albumin, and prealbumin levels are used to assess nutritional status. |
| psychological states | Baseline, 4 weeks prior to surgery, 3 days prior to surgery | Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms. |
| 6 minutes walking test | Baseline, 4 weeks prior to surgery, 3 days prior to surgery | The 6-minute walking test (6MWT) can be used to measure physical capacity to reflect cardiopulmonary function. The test involves walking as quickly as possible for six minutes in a quiet, flat corridor of 15m length, with distance recorded. Each patient will perform two tests, one hour apart, with the longer distance used for data analysis. |
| The proportion of neoadjuvant therapy completed as planned | 4 weeks prior to surgery | — |
| postoperative hospital stay | Postoperative 30 days | — |
| Prognostic Nutritional Index (PNI) | Baseline, 4 weeks prior to surgery, 3 days prior 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. |
| Quality of life-EORTC QLQ-STO22 | Baseline, 4 weeks prior to surgery, 3 days prior to 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. |
| Adherence to the prehabilitation plan | 1 days prior to surgery | Completion of more than 75% of the prerehabilitation protocol was considered good adherence |
| Quality of life - EORTC QLQ-C30 | Baseline, 4 weeks prior to surgery, 3 days prior to surgery | Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The questionnaire assesses 15 dimensions of HRQoL, including physical, psychological, and social functions. |
Countries
China
Contacts
CONTACTQi Liu, MD
CONTACTYanbing Zhou, MD
PRINCIPAL_INVESTIGATORYanbing Zhou, MD
The Affiliated Hospital of Qingdao University
Outcome results
None listed