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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

NCT07732543 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-07-29

No results posted yet for this study

Summary

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

Conditions

  • Gastric Cancer (GC)
  • Immunotherapy

Interventions

BEHAVIORAL

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

Sponsors & Collaborators

  • National Yang Ming Chiao Tung University

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • I-Wen Chang, PhD · Department of Nursing, Taipei Veterans General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-21
Primary Completion
2029-07-31
Completion
2030-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07732543 on ClinicalTrials.gov