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
23 июля 2026 г. обновлено: 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
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
110
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Shiow-Ching Shun, PhD
- Номер телефона: +886911268998
- Электронная почта: scshun@nycu.edu.tw
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Intervention
AI-ISME&HE intervention group
|
|
|
Без вмешательства: Control
Usual routine care
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)
Временное ограничение: 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
Временное ограничение: 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:
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
Level of Frailty Assessed by Geriatric 8 (G8)
Временное ограничение: 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)
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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®)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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.
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Учебный стул: I-Wen Chang, PhD, Department of Nursing, Taipei Veterans General Hospital
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
21 июля 2026 г.
Первичное завершение (Оцененный)
31 июля 2029 г.
Завершение исследования (Оцененный)
31 июля 2030 г.
Даты регистрации исследования
Первый отправленный
23 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
23 июля 2026 г.
Первый опубликованный (Действительный)
29 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
29 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
23 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026-02-009CC
- 115-2314-B-A49 -016 -MY3 (Другой номер гранта/финансирования: National Science and Technology Council)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .