Gastric Cancer (GC), Immunotherapy
Conditions
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
Interventions
BEHAVIORALAI-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
Taipei Veterans General Hospital, Taiwan
National Yang Ming Chiao Tung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥18 years 2. diagnosed as AGC (TNM: T2\~T4, N\>0, Any M, Stage: III\~IV, or unresectable GC) 3. scheduled to receive the first cycle of immunotherapy 4. willingness to provide written informed consent after receiving a full explanation of the study
Exclusion criteria
1. a diagnosis of another type of cancer within the past five years 2. inability to communicate clearly 3. a diagnosis of dementia 4. acute pulmonary embolism 5. acute myocardial infarction 6. extremity bone fracture within the past three months 7. bone metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Frailty Assessed by The Short Physical Performance Battery (SPPB) | Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline. | 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 | Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline. | 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) | Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline. | 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) | Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline. | The TCFT score from 0-5 points, with score \>0 indicating frailty. It has good ROC values of 0.857 in cancer patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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) | Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline. | 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 | Record patient's survival status at baseline, 1 year after baseline, and 2 year after baseline. | 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®) | Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline. | 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. |
| 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. | 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. |
| Level of Cognitive Function Assessed by The Montreal Cognitive Assessment (MoCA) | Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline. | 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. |
| Level of Depression Assessed by The Patient Health Questionnaire-9 (PHQ-9) | Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline. | 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. |
| Level of Physical Function Assessed by Grip Strength (GS) | Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline. | 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. |
| Changes of Body Composition Assessed by Body Composition Machine | Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline. | 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. |
Contacts
CONTACTShiow-Ching Shun, PhD
STUDY_CHAIRI-Wen Chang, PhD
Department of Nursing, Taipei Veterans General Hospital
Outcome results
None listed