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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

23 luglio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

110

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention
AI-ISME&HE intervention group
Comportamentale: 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
Nessun intervento: Control
Usual routine care

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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®)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaboratori

National Yang Ming Chiao Tung University

Investigatori

  • Cattedra di studio: I-Wen Chang, PhD, Department of Nursing, Taipei Veterans General Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

21 luglio 2026

Completamento primario (Stimato)

31 luglio 2029

Completamento dello studio (Stimato)

31 luglio 2030

Date di iscrizione allo studio

Primo inviato

23 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 luglio 2026

Primo Inserito (Effettivo)

29 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-02-009CC
  • 115-2314-B-A49 -016 -MY3 (Altro numero di sovvenzione/finanziamento: National Science and Technology Council)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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