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

N/ANot Yet RecruitingNCT07755917

The Affiliated Hospital of Qingdao University490 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

490

Conditions

Gastric Cancer Prehabilitation

Interventions

mHealth prehabilitation groupBEHAVIORAL

receiving at least 4 weeks of 5G+AI digitally supervised home-based multi-modal prehabilitation plus standard ERAS perioperative management

ERAS groupOTHER

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 * 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)

Outcomes

Primary Outcomes

postoperative complications

comprehensive complication index (CCI)

Time frame: postoperative 30 days

Secondary Outcomes

six minute walk test (6MWT)

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.

Time frame: Baseline, before surgery

Oncological outcomes

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

Time frame: 3 years after surgery

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, Before surgery

Quality of life - EORTC QLQ-C30

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.

Time frame: Baseline, Before 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.

Central Contacts

Yulong Tian

CONTACT

86532-82911324 zhouyanbing@qduhospital.cn

Yanbing Zhou

CONTACT

86532-82911324 zhouyanbing@qduhospital.cn

Data from ClinicalTrials.gov

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