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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

2026年7月23日 更新者：Taipei Veterans General Hospital, Taiwan

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

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

110

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. age ≥18 years
  2. diagnosed as AGC (TNM: T2~T4, N>0, Any M, Stage: III~IV, or unresectable GC)
  3. scheduled to receive the first cycle of immunotherapy
  4. willingness to provide written informed consent after receiving a full explanation of the study

Exclusion Criteria:

  1. a diagnosis of another type of cancer within the past five years
  2. inability to communicate clearly
  3. a diagnosis of dementia
  4. acute pulmonary embolism
  5. acute myocardial infarction
  6. extremity bone fracture within the past three months
  7. bone metastasis

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention
AI-ISME&HE intervention group
行为的：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
无干预：Control
Usual routine care

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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.
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Frailty Assessed by Comprehensive Geriatrics Assessment
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

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:

  1. Functional status: Grip strength.
  2. Comorbidity: Charlson Comorbidity Index by ICD-10 and exclude age and cancer diagnosis. CCI scores > 3 indicates multimorbidity.
  3. Cognition: the Montreal Cognitive Assessment (MoCA).
  4. Mood: Geriatric Patient Health Questionnaire-9 (PHQ-9).
  5. Nutritional status: Mini Nutritional Assessment (MNA).
  6. Polypharmacy: number of daily medications.
  7. Social support: live alone or with family.
  8. Falls history: the falling times in the past year.
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Frailty Assessed by Geriatric 8 (G8)
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
The G8 score from 0-17 points, with score ≤14 indicating frailty. It has good sensitivity (86.9%) in cancer patients
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Frailty Assessed by Taiwan Cancer Frailty Tool (TCFT)
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
The TCFT score from 0-5 points, with score >0 indicating frailty. It has good ROC values of 0.857 in cancer patients
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

次要结果测量

结果测量
措施说明
大体时间
Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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.
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Self-efficacy Assessed by The Modified Cancer Behavior Inventory (CBI)
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
It is a 0-10 Likert-type scale, where 0 indicates no confidence at all and 10 indicates fully confidence.
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
All Cause Mortality After 2 Year Follow-up
大体时间：Record patient's survival status at baseline, 1 year after baseline, and 2 year after baseline.
The survival status of the patients will be followed by medical record.
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®)
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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.
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)
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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.
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Cognitive Function Assessed by The Montreal Cognitive Assessment (MoCA)
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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.
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Depression Assessed by The Patient Health Questionnaire-9 (PHQ-9)
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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.
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Level of Physical Function Assessed by Grip Strength (GS)
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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.
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
Changes of Body Composition Assessed by Body Composition Machine
大体时间：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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.
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Taipei Veterans General Hospital, Taiwan

合作者

National Yang Ming Chiao Tung University

调查人员

  • 学习椅：I-Wen Chang, PhD、Department of Nursing, Taipei Veterans General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月21日

初级完成 (估计的)

2029年7月31日

研究完成 (估计的)

2030年7月31日

研究注册日期

首次提交

2026年7月23日

首先提交符合 QC 标准的

2026年7月23日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月23日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2026-02-009CC
  • 115-2314-B-A49 -016 -MY3 (其他赠款/资助编号：National Science and Technology Council)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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