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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-ISME&HE.
- Who it may be relevant to
- Registry conditions: Gastric Cancer (GC), Immunotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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. 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
Interventions
- Behavioral AI-ISME&HE
* 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
Primary outcome measures
- Level of Frailty Assessed by The Short Physical Performance Battery (SPPB) [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
- Level of Frailty Assessed by Comprehensive Geriatrics Assessment [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
- Level of Frailty Assessed by Geriatric 8 (G8) [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
- Level of Frailty Assessed by Taiwan Cancer Frailty Tool (TCFT) [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
Secondary outcome measures (9)
- Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
- Level of Self-efficacy Assessed by The Modified Cancer Behavior Inventory (CBI) [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
- All Cause Mortality After 2 Year Follow-up [Time frame: 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®) [Time frame: 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) [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
- Level of Cognitive Function Assessed by The Montreal Cognitive Assessment (MoCA) [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
- Level of Depression Assessed by The Patient Health Questionnaire-9 (PHQ-9) [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
- Level of Physical Function Assessed by Grip Strength (GS) [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
- Changes of Body Composition Assessed by Body Composition Machine [Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07732543 · 2026-02-009CC · 115-2314-B-A49 -016 -MY3