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 | Not Yet Recruiting

• 2 other identifiers: 2026-02-009CC115-2314-B-A49 -016 -MY3
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (4)

• Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)

  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

  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)

  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)

  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.

Secondary Outcomes (9)

• Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)

  Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

• Level of Self-efficacy Assessed by The Modified Cancer Behavior Inventory (CBI)

  Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

• All Cause Mortality After 2 Year Follow-up

  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®)

  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)

  Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

Study Arms (2)

Intervention

EXPERIMENTAL

AI-ISME\&HE intervention group

Behavioral: AI-ISME&HE

Control

NO INTERVENTION

Usual routine care

Interventions

AI-ISME&HE BEHAVIORAL

* 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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Yang Ming Chiao Tung University: collaborator

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• I-Wen Chang, PhD

  Department of Nursing, Taipei Veterans General Hospital

  STUDY CHAIR

Central Study Contacts

Shiow-Ching Shun, PhD

CONTACT

+886911268998; scshun@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Given the design of the exercise-based intervention, blinding of participants and intervention providers is not feasible. However, the research assistant to collect data for post-intervention follow-up evaluations will be blinded to group assignment to reduce potential bias. In addition, outcome assessments will be conducted using standardized and validated instruments, and data collection procedures will be strictly standardized to minimize measurement bias.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start: July 21, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-07