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
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
a diagnosis of another type of cancer within the past five years
inability to communicate clearly
a diagnosis of dementia
acute pulmonary embolism
Parallel
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
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.
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.
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
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
Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)
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.
Level of Self-efficacy Assessed by The Modified Cancer Behavior Inventory (CBI)
It is a 0-10 Likert-type scale, where 0 indicates no confidence at all and 10 indicates fully confidence.
All Cause Mortality After 2 Year Follow-up
The survival status of the patients will be followed by medical record.
Level of Symptom Severity Assessed by The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
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.
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Taipei Veterans General Hospital, Taiwan
Lead sponsor
National Yang Ming Chiao Tung University
Collaborator
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