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

Обзор

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

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Level of Frailty Assessed by The Short Physical Performance Battery (SPPB) [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
• Level of Frailty Assessed by Comprehensive Geriatrics Assessment [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
• Level of Frailty Assessed by Geriatric 8 (G8) [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
• Level of Frailty Assessed by Taiwan Cancer Frailty Tool (TCFT) [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]

Вторичные конечные точки (9)

• Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
• Level of Self-efficacy Assessed by The Modified Cancer Behavior Inventory (CBI) [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
• All Cause Mortality After 2 Year Follow-up [Срок оценки: 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®) [Срок оценки: 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) [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
• Level of Cognitive Function Assessed by The Montreal Cognitive Assessment (MoCA) [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
• Level of Depression Assessed by The Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
• Level of Physical Function Assessed by Grip Strength (GS) [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]
• Changes of Body Composition Assessed by Body Composition Machine [Срок оценки: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07732543 · 2026-02-009CC · 115-2314-B-A49 -016 -MY3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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