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 de julho de 2026 atualizado por: 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
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
110
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Shiow-Ching Shun, PhD
- Número de telefone: +886911268998
- E-mail: scshun@nycu.edu.tw
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention
AI-ISME&HE intervention group
|
|
|
Sem intervenção: Control
Usual routine care
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)
Prazo: 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
Prazo: 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.
|
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Level of Frailty Assessed by Geriatric 8 (G8)
Prazo: 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)
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)
Prazo: 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)
Prazo: 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.
|
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All Cause Mortality After 2 Year Follow-up
Prazo: 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.
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Record patient's survival status at baseline, 1 year after baseline, and 2 year after baseline.
|
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Level of Symptom Severity Assessed by The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
Prazo: 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.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
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Level of Nutrition Status Assessed by The Mini Nutritional Assessment Short Form (MNA-SF)
Prazo: 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.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
Level of Cognitive Function Assessed by The Montreal Cognitive Assessment (MoCA)
Prazo: 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.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Level of Depression Assessed by The Patient Health Questionnaire-9 (PHQ-9)
Prazo: 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.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
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Level of Physical Function Assessed by Grip Strength (GS)
Prazo: 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.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Changes of Body Composition Assessed by Body Composition Machine
Prazo: 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.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: I-Wen Chang, PhD, Department of Nursing, Taipei Veterans General Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
21 de julho de 2026
Conclusão Primária (Estimado)
31 de julho de 2029
Conclusão do estudo (Estimado)
31 de julho de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
23 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de julho de 2026
Primeira postagem (Real)
29 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-02-009CC
- 115-2314-B-A49 -016 -MY3 (Número de outro subsídio/financiamento: National Science and Technology Council)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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