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NCT Number: NCT07755917

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mHealth prehabilitation group

Behavioral

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

ERAS Group

Other

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.

Primary outcomes

  1. postoperative complications

    Time frame: postoperative 30 days

    comprehensive complication index (CCI)

Secondary outcomes

  1. six minute walk test (6MWT)

    Time frame: 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.

  2. Oncological outcomes

    Time frame: 3 years after surgery

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

  3. psychological states

    Time frame: Baseline, Before surgery

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

  4. Quality of life - EORTC QLQ-C30

    Time frame: 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.

  5. Quality of life-EORTC QLQ-STO22

    Time frame: 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.

  6. Prognostic Nutritional Index (PNI)

    Time frame: 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.

  7. postoperative hospital stay

    Time frame: Postoperative 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Yanbing Zhou

CONTACT

[email protected]

86532-82911324

Yulong Tian

CONTACT

[email protected]

86532-82911324

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Collaborators

  • Dongying People's Hospital
  • First Affiliated Hospital, Sun Yat-Sen University
  • Jining First People's Hospital
  • Peking University Cancer Hospital (Inner Mongolia Campus)
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Rizhao People's Hospital
  • Shandong Cancer Hospital and Institute
  • Shandong Provincial Hospital
  • Sixth Affiliated Hospital, Sun Yat-sen University
  • The Affiliated Hospital of Shandong Second Medical University
  • The Second Hospital of Shandong University
  • Weifang People's Hospital
  • Yantai Yuhuangding Hospital

Registry information

Official study title

Preoperative Multi-mode Prehabilitation Management for Neoadjuvant Chemotherapy Gastric Cancer Patients Supervised at Home Based on 5G + AI Mobile Health (mHealth): A Multicenter RCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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