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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- 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.)
- Level of Cognitive Function Assessed by The Montreal Cognitive Assessment (MoCA)(Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.)
- Level of Depression Assessed by The Patient Health Questionnaire-9 (PHQ-9)(Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.)
- Level of Physical Function Assessed by Grip Strength (GS)(Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.)
- Changes of Body Composition Assessed by Body Composition Machine(Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.)