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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

a diagnosis of another type of cancer within the past five years

inability to communicate clearly

a diagnosis of dementia

acute pulmonary embolism

Trial design

Treatments tested in this trial

  • AI-ISME&HE

Treatment groups

110 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Taipei Veterans General Hospital, Taiwan

Lead sponsor

National Yang Ming Chiao Tung University

Collaborator