Gastric Cancer (GC)NCT07732543
Developing and Testing the Effectiveness of Smart Healthcare Assisted Individualized Symptom Management Education and Home-based Exercise on Frailty, Treatment-related Adverse Events and Quality of Life in Advanced Gastric Cancer Patients Receiving Immunotherapy
A study testing AI-ISME&HE in people with Gastric Cancer (GC) and Immunotherapy, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
The goal of this randomized controlled intervention is to develop and evaluate the effectiveness of the nurse-led with AI chatbot Individualized Symptom Management Education and Home-based Exercise (AI-ISME\&HE) based on The Theory of Symptom Self-Management (TSSM) on frailty, self-efficacy in cancer care, trAE, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer (GC), Immunotherapy
- What is being tested?
- AI-ISME&HE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2026to 31 Jul 2030
- Phase
- Interventional
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
- age ≥18 years
- diagnosed as AGC (TNM: T2~T4, N>0, Any M, Stage: III~IV, or unresectable GC)
- scheduled to receive the first cycle of immunotherapy
- willingness to provide written informed consent after receiving a full explanation of the study
Who cannot join
- a diagnosis of another type of cancer within the past five years
- inability to communicate clearly
- a diagnosis of dementia
- acute pulmonary embolism
- acute myocardial infarction
- extremity bone fracture within the past three months
- bone metastasis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this randomized controlled intervention is to develop and evaluate the effectiveness of the nurse-led with AI chatbot Individualized Symptom Management Education and Home-based Exercise (AI-ISME\&HE) based on The Theory of Symptom Self-Management (TSSM) on frailty, self-efficacy in cancer care, trAE, and quality of life in advanced gastric cancer patients receiving immunotherapy. The main questions it aims to answer are:
- Can AI-ISME\&HE reduces frailty in advanced gastric cancer patients receiving immunotherapy?
- Can AI-ISME\&HE increases quality of life in advanced gastric cancer patients receiving immunotherapy?
- Can AI-ISME\&HE increases self-efficacy in advanced gastric cancer patients receiving immunotherapy?
- Can AI-ISME\&HE reduces all-caused death in advanced gastric cancer patients receiving immunotherapy within two years? Researchers will compare usual routine care to see if AI-ISME\&HE can reduce frailty, all-caused death and increase quality of life and self-efficacy.
Read more
Participants will not be blinded, but the outcome evaluator will be blinded. The participants will be asked to complete three tasks for 12 weeks:
- Self-reporting treatment-related adverse events
- Interacting with AI-ISME\&HE for seeking information related to self-management educational materials, including symptom management with the most reported trAEs and prevention from frailty
- ViviFrail-based exercise
- Conditions
- Gastric Cancer (GC), Immunotherapy
- Being tested
- AI-ISME&HE
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-ISME&HEBehavioural
- Self-reporting treatment-related adverse events
- Interacting with AI-ISME\&HE for seeking information related to self-management educational materials, including symptom management with the most reported trAEs and prevention from frailty
- ViviFrail-based exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | AI-ISME\&HE intervention group Receives: Behavioral: AI-ISME&HE |
| Control | No intervention | Usual routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)
The SPPB score from 0-12 points, with 10-12 indicating robust, 7-9 indicating prefrail, and 4-6 indicating frail. It has good reliability (ICC range from 0.82-0.92) and validity.
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Frailty Assessed by Comprehensive Geriatrics Assessment
A total of 8 domains were used to comprehensively assess frailty in cancer patients: Functional status, Comorbidity, Nutrition, Polypharmacy, Social support, Cognition, and Mood. 0 abnormal domains indicate robust, any 1 abnormal indicates pre-frail, and 2 or more abnormality indicate frailty. Each domain can be assessed by different tools. In this study, we chose the tools according as follows:
- Functional status: Grip strength.
- Comorbidity: Charlson Comorbidity Index by ICD-10 and exclude age and cancer diagnosis. CCI scores > 3 indicates multimorbidity.
- Cognition: the Montreal Cognitive Assessment (MoCA).
- Mood: Geriatric Patient Health Questionnaire-9 (PHQ-9).
- Nutritional status: Mini Nutritional Assessment (MNA).
- Polypharmacy: number of daily medications.
- Social support: live alone or with family.
- Falls history: the falling times in the past year.
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Frailty Assessed by Geriatric 8 (G8)
The G8 score from 0-17 points, with score ≤14 indicating frailty. It has good sensitivity (86.9%) in cancer patients
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Frailty Assessed by Taiwan Cancer Frailty Tool (TCFT)
The TCFT score from 0-5 points, with score >0 indicating frailty. It has good ROC values of 0.857 in cancer patients
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Secondary outcomes (9)
Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)
It includes 7 items and compromised physical well-being (3 items), emotional well-being (1 items), and functional well-being (3 items). The score of each item is from 0 (not at all) to 5 (very much), and the total score ranging from 0 to 28, with a higher score indicating better quality of life.
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Self-efficacy Assessed by The Modified Cancer Behavior Inventory (CBI)
It is a 0-10 Likert-type scale, where 0 indicates no confidence at all and 10 indicates fully confidence.
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
All Cause Mortality After 2 Year Follow-up
The survival status of the patients will be followed by medical record.
Measured: Record patient's survival status at baseline, 1 year after baseline, and 2 year after baseline.
Level of Symptom Severity Assessed by The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
The 14 symptoms include fatigue, headache, shortness of breath, nausea/vomiting, rash, diarrhea, decreased appetite, numbness/tingling, general pain, blurred vision, constipation, abdominal pain, itching, and dizziness. Symptoms are assessed by using five-point Likert-type scale to rate symptom frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), and interference (not at all, a little bit, somewhat, quite a bit, very much) in the past 7 days. It can composite grading based on an algorithm into grade 0 to 3.
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Nutrition Status Assessed by The Mini Nutritional Assessment Short Form (MNA-SF)
It includes 6 items relating to food intake in the past three months, weight loss in the past three months, physical activity, stress, dementia or depression, and body mass index (BMI). The total score ranges from 0-14, with 12-14 representing well, 8-11 representing at risk, and 0-7 representing malnutrition.
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Cognitive Function Assessed by The Montreal Cognitive Assessment (MoCA)
The scale consists of 12 items with a total score ranging from 0 to 30, assessing cognitive function across eight domains, including visuospatial construction, executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. A score of 24 below indicates cognitive impairment.
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Depression Assessed by The Patient Health Questionnaire-9 (PHQ-9)
PHQ-9 is a depression muddle from the complete PHQ, including nine DSM-IV criteria for depression, each item scores from 0-3, with a total score range from 0-27. A higher score indicates higher severity of depression, with a score 0-4 as none, 5-9 as mild, and ≥ 10 as moderate-severe depression.
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Physical Function Assessed by Grip Strength (GS)
GS will be assessed by JAMAR hydraulic dynamometer, which show good reliability. The participants will be asked to sit in the neutral position with their elbows flexed at 90° and resting at their sides. Next, they need to squeeze the handle of the dynamometer for 3-5 seconds as hard as possible for 3 trials on dominant hand with a rest of 60 seconds. The average and the maximum of the grip strength (kg) will be recorded. Female with GS ≤ 16 kg and male ≤ 26.7 kg refer to frailty.
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Changes of Body Composition Assessed by Body Composition Machine
Body composition will be examined by ACCUNIQ BC300 which is a lightweight, foldable professional body composition analyzer that utilizes bioelectrical impedance analysis (BIA) technology. Through eight electrodes and three different frequencies (5, 50, 250 kHz), it performs full-body and segmented (arms, legs, torso) measurements, quickly providing detailed data such as body fat, muscle mass, and water content with high accuracy within 5 minutes.
Measured: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start21 Jul 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Sponsor
- Investigators
- I-Wen Chang, PhD, Study chair, Department of Nursing, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732543
- Sponsor's protocol ID
- 2026-02-009CC
- Other IDs
- 115-2314-B-A49 -016 -MY3
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No