Gastric CancermHealth prehabNCT07764523
Home-based Whole Course Multimodal Prehabilitation Based on 5G + Artificial Intelligence Mobile Health
A study testing mHealth prehabilitation group and ERAS group in people with Gastric Cancer and Prehabilitation, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Prehabilitation
- What is being tested?
- mHealth prehabilitation group and ERAS group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Affiliated Hospital of QIngdao University
Qingdao, Shandong
Yanbing Zhou, MD, 86532-82911324, zhouyanbing@qduhospital.cn
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Gastric Cancer, Prehabilitation
- Being tested
- mHealth prehabilitation group, ERAS group
- Keywords
- gastric cancer, prehabilitation, mobile health
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth prehabilitation groupBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| prehabilitation group | Experimental | The prehabilitation group will receive multimodal prehabilitation combined with ERAS before gastrectomy. Receives: Behavioral: mHealth prehabilitation group; Behavioral: ERAS group |
| ERAS group | Placebo comparator | The ERAS group patients will be managed according to the ERAS pathway. Receives: Behavioral: ERAS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative 30 days
Secondary outcomes (12)
psychological states
Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms.
Measured: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
6 minutes walking test
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.
Measured: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
The proportion of neoadjuvant therapy completed as planned
Measured: 4 weeks prior to surgery
postoperative hospital stay
Measured: Postoperative 30 days
Prognostic Nutritional Index (PNI)
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.
Measured: Baseline, 4 weeks prior to surgery, 3 days prior to 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.
Measured: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
Quality of life - EORTC QLQ-C30
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.
Measured: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
Adherence to the prehabilitation plan
Completion of more than 75% of the prerehabilitation protocol was considered good adherence
Measured: 1 days prior to surgery
Oncological outcomes
3-year recurrence-free survival and 3-year overall survival
Measured: 3 years
Body weight
Measured: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
Inflammatory indicators-white blood cell count, neutrophil count, lymphocyte count, monocyte count, platelet count
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.
Measured: Baseline, 4 weeks prior to surgery, 3 days prior to surgery, and postoperative days 1, 3, and 5
Nutritional status-hemoglobin, albumin, prealbumin levels
Hemoglobin, albumin, and prealbumin levels are used to assess nutritional status.
Measured: Baseline, 4 weeks prior to surgery, 3 days prior to surgery, and postoperative days 1, 3, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital (Inner Mongolia Campus), People's Hospital of Xinjiang Uygur Autonomous Region, First Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University, Shandong Provincial Hospital, The Second Hospital of Shandong University, Yantai Yuhuangding Hospital, The Affiliated Hospital of Shandong Second Medical University, Weifang People's Hospital, Shandong Cancer Hospital and Institute, Dongying People's Hospital, Rizhao People's Hospital, Jining First People's Hospital
- Responsible party
- Principal investigator, Zhou Yanbing, The Affiliated Hospital of Qingdao University
- Investigators
- Yanbing Zhou, MD, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764523
- Sponsor's protocol ID
- GISSG-PREHAB2601
- Acronym
- mHealth prehab
- Status last verified
- May 2026
- First submitted
- 20 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07764523
- Acronym / sponsor ID
- mHealth prehab / GISSG-PREHAB2601
- Conditions
- Gastric Cancer, Prehabilitation
- Keywords
- gastric cancer, prehabilitation, mobile health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital (Inner Mongolia Campus), People's Hospital of Xinjiang Uygur Autonomous Region, First Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University, Shandong Provincial Hospital, The Second Hospital of Shandong University, Yantai Yuhuangding Hospital, The Affiliated Hospital of Shandong Second Medical University, Weifang People's Hospital, Shandong Cancer Hospital and Institute, Dongying People's Hospital, Rizhao People's Hospital, Jining First People's Hospital
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prehabilitation group | Experimental | Behavioral: mHealth prehabilitation group, Behavioral: ERAS groupThe prehabilitation group will receive multimodal prehabilitation combined with ERAS before gastrectomy. |
| ERAS group | Placebo comparator | Behavioral: ERAS groupThe ERAS group patients will be managed according to the ERAS pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth prehabilitation groupParticipants 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. | Behavioural | prehabilitation group |
| ERAS groupThe 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. | Behavioural | ERAS group, prehabilitation group |
Primary outcome
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.
12 secondary outcomes
psychological states
Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
6 minutes walking test
Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
The proportion of neoadjuvant therapy completed as planned
Time frame: 4 weeks prior to surgery
postoperative hospital stay
Time frame: Postoperative 30 days
Prognostic Nutritional Index (PNI)
Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
Quality of life-EORTC QLQ-STO22
Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
Quality of life - EORTC QLQ-C30
Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
Adherence to the prehabilitation plan
Time frame: 1 days prior to surgery
Oncological outcomes
Time frame: 3 years
Body weight
Time frame: Baseline, 4 weeks prior to surgery, 3 days prior to surgery
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanbing Zhou, MD principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth prehabilitation group and ERAS group in people with Gastric Cancer and Prehabilitation, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Liu, MD (86532-82911324, lq112867@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive complication index (CCI) (time frame: postoperative 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.