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

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.

Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

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.

Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

All Cause Mortality After 2 Year Follow-up

The survival status of the patients will be followed by medical record.

Time frame: 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®)

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.

Time frame: 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)

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.

Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

Level of Cognitive Function Assessed by The Montreal Cognitive Assessment (MoCA)

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.

Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

Level of Depression Assessed by The Patient Health Questionnaire-9 (PHQ-9)

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.

Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

Level of Physical Function Assessed by Grip Strength (GS)

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.

Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.

Changes of Body Composition Assessed by Body Composition Machine

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.

Time frame: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.