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

NCT07755917 | Not Yet Recruiting DMC

• 1 other identifier: GISSG-PREHAB2603
• Study Type: interventional
• Target: 490
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prehabilitation; Gastric Cancer

Keywords

gastric cancer; prehabilitation

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  comprehensive complication index (CCI)

  postoperative 30 days

Secondary Outcomes (7)

• six minute walk test (6MWT)

  Baseline, before surgery

• Oncological outcomes

  3 years after surgery

• psychological states

  Baseline, Before surgery

• Quality of life - EORTC QLQ-C30

  Baseline, Before surgery

• Quality of life-EORTC QLQ-STO22

  Baseline, Before surgery

Study Arms (2)

prehabilitation group

EXPERIMENTAL

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

Behavioral: mHealth prehabilitation group

ERAS group

PLACEBO COMPARATOR

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

Other: ERAS group

Interventions

mHealth prehabilitation group BEHAVIORAL

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

prehabilitation group

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.

ERAS 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
• 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

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
• 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
• Peking University Cancer Hospital (Inner Mongolia Campus): collaborator

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

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yulong Tian

CONTACT

86532-82911324; zhouyanbing@qduhospital.cn

Yanbing Zhou

CONTACT

86532-82911324; zhouyanbing@qduhospital.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• 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: August 2, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share