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 juillet 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
110
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Shiow-Ching Shun, PhD
- Numéro de téléphone: +886911268998
- E-mail: scshun@nycu.edu.tw
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
AI-ISME&HE intervention group
|
|
|
Aucune intervention: Control
Usual routine care
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)
Délai: 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)
Délai: 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
Délai: 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®)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: I-Wen Chang, PhD, Department of Nursing, Taipei Veterans General Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
21 juillet 2026
Achèvement primaire (Estimé)
31 juillet 2029
Achèvement de l'étude (Estimé)
31 juillet 2030
Dates d'inscription aux études
Première soumission
23 juillet 2026
Première soumission répondant aux critères de contrôle qualité
23 juillet 2026
Première publication (Réel)
29 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-02-009CC
- 115-2314-B-A49 -016 -MY3 (Autre subvention/numéro de financement: National Science and Technology Council)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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