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

NCT07764523 | Not Yet Recruiting DMC

• 1 other identifier: GISSG-PREHAB2601
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Prehabilitation

Keywords

gastric cancer; prehabilitation; mobile health

Outcome Measures

Primary Outcomes (1)

• 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.

  postoperative 30 days

Secondary Outcomes (12)

• psychological states

  Baseline, 4 weeks prior to surgery, 3 days prior to surgery

• 6 minutes walking test

  Baseline, 4 weeks prior to surgery, 3 days prior to surgery

• 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

Study Arms (2)

prehabilitation group

EXPERIMENTAL

The prehabilitation group will receive multimodal prehabilitation combined with ERAS before gastrectomy.

Behavioral: mHealth prehabilitation group; Behavioral: ERAS group

ERAS group

PLACEBO COMPARATOR

The ERAS group patients will be managed according to the ERAS pathway.

Behavioral: ERAS group

Interventions

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.

prehabilitation group

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.

ERAS group; prehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

the Affiliated Hospital of QIngdao University

Qingdao, Shandong, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yanbing Zhou, MD

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi Liu, MD

CONTACT

86532-82911324; lq112867@163.com

Yanbing Zhou, MD

CONTACT

86532-82911324; zhouyanbing@qduhospital.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Director of the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2030
• Last Updated: August 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)