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

N/ANot Yet RecruitingNCT07764523

The Affiliated Hospital of Qingdao University328 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

328

Conditions

Gastric Cancer Prehabilitation

Interventions

mHealth prehabilitation groupBEHAVIORAL

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 groupBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Comprehensive complication index (CCI)

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.

Time frame: postoperative 30 days

Secondary Outcomes

psychological states

Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms.

Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery

6 minutes walking test

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.

Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery

The proportion of neoadjuvant therapy completed as planned

Time frame: 4 weeks prior to surgery

postoperative hospital stay

Time frame: Postoperative 30 days

Prognostic Nutritional Index (PNI)

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.

Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery

Quality of life-EORTC QLQ-STO22

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.

Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery

Quality of life - EORTC QLQ-C30

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.

Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery

Adherence to the prehabilitation plan

Completion of more than 75% of the prerehabilitation protocol was considered good adherence

Time frame: 1 days prior to surgery

Oncological outcomes

3-year recurrence-free survival and 3-year overall survival

Time frame: 3 years

Body weight

Time frame: 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

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.

Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery, and postoperative days 1, 3, and 5

Nutritional status-hemoglobin, albumin, prealbumin levels

Hemoglobin, albumin, and prealbumin levels are used to assess nutritional status.

Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery, and postoperative days 1, 3, and 5

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts