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NCT Number: NCT07764523

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Prehabilitation Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

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
  • 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)

Treatment and study plan

mHealth prehabilitation group

Behavioral

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 group

Behavioral

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. Comprehensive complication index (CCI)

    Time frame: 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 outcomes

  1. psychological states

    Time frame: 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.

  2. 6 minutes walking test

    Time frame: 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.

  3. The proportion of neoadjuvant therapy completed as planned

    Time frame: 4 weeks prior to surgery

  4. postoperative hospital stay

    Time frame: Postoperative 30 days

  5. Prognostic Nutritional Index (PNI)

    Time frame: 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.

  6. Quality of life-EORTC QLQ-STO22

    Time frame: 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.

  7. Quality of life - EORTC QLQ-C30

    Time frame: 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.

  8. Adherence to the prehabilitation plan

    Time frame: 1 days prior to surgery

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

  9. Oncological outcomes

    Time frame: 3 years

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

  10. Body weight

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

  11. Inflammatory indicators-white blood cell count, neutrophil count, lymphocyte count, monocyte count, platelet count

    Time frame: 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.

  12. Nutritional status-hemoglobin, albumin, prealbumin levels

    Time frame: 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.

Study contacts

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

Qi Liu, MD

CONTACT

[email protected]

86532-82911324

Yanbing Zhou, MD

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

Whole-course Multi-modal Prehabilitation Management for Neoadjuvant Chemotherapy Gastric Cancer Patients Supervised at Home-based on 5G + AI Mobile Health (mHealth): a Multicenter Prospective Randomized Control Trial

Acronym: mHealth prehab

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Aug 14, 2026
Registry last updated
Aug 14, 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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