A Randomized Controlled Trial to Evaluate the Effects of a Visual-Interactive LINE Chatbot on Self-Management of EGFR-TKI-Related Side Effects in Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 178
- 主要终点
- Self-Management Ability（PAM-13）
研究概览
简要总结
This study aims to evaluate a visual interactive LINE chatbot designed to support self-management of treatment-related side effects among patients with advanced lung cancer receiving epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy.
Patients receiving EGFR-TKI treatment often experience long-term side effects that require ongoing self-management. In this randomized controlled trial, participants will be assigned to receive either usual care alone or usual care plus access to the LINE chatbot intervention, which provides visualized and interactive educational content for symptom monitoring and self-care.
The primary outcome of this study is self-management ability related to EGFR-TKI-associated side effects. Secondary outcomes include quality of life during treatment and overall satisfaction with the LINE chatbot intervention.
详细描述
The objective of this study is to evaluate a visual interactive LINE chatbot designed to support self-management of treatment-related side effects among patients with advanced lung cancer receiving epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy.
This study uses a randomized controlled trial design. Participants will be recruited from a medical center in northern Taiwan and randomly assigned to either an intervention group or a control group. The control group will receive standard education and routine clinical care, while the intervention group will receive standard care plus access to the visual interactive LINE chatbot intervention. The chatbot provides visualized and interactive educational content to support symptom monitoring and self-care during treatment.
Assessments will be conducted at baseline and at multiple follow-up time points after enrollment to evaluate self-management ability related to EGFR-TKI-associated side effects, quality of life during treatment, and overall satisfaction with the chatbot intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients with newly diagnosed stage IIIB to IVB unresectable or inoperable non-small cell lung cancer (NSCLC), or those with first disease recurrence who are receiving oral targeted therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, with the ability to perform self-care activities.
- •Patients receiving epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy, including gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib.
- •Willingness to participate in the study, with completion of the informed consent process and provision of written informed consent.
- •Ability to communicate in Chinese and to independently operate a smartphone and use the LINE application.
排除标准
- •Patients diagnosed with a second primary malignancy or multiple malignancies.
- •Patients receiving other anticancer treatments.
研究组 & 干预措施
LINE Chatbot Intervention Group
Participants receive usual care plus access to a visual interactive LINE chatbot designed to support self-management of treatment-related side effects during EGFR-TKI therapy.
干预措施: Visual-Interactive LINE Chatbot (Behavioral)
usual care
Participants receive usual care, which consists of standard paper-based educational materials provided as part of routine clinical care, without access to the LINE chatbot.
结局指标
主要结局
Self-Management Ability（PAM-13）
时间窗: at baseline and at 1, 3, and 6 months post-intervention
Self-management ability is measured using the Patient Activation Measure (PAM-13) developed by Hibbard et al. (2005). The PAM-13 consists of 13 items assessing an individual's knowledge, skills, and confidence in managing their health or chronic condition. Each item is rated on a 4-point Likert scale, and raw scores are transformed into a standardized score ranging from 0 to 100, with higher scores indicating greater self-management ability and willingness to engage in self-care. The Chinese version of the PAM-13 has demonstrated good internal consistency, with a Cronbach's alpha of 0.835.
Self-Management Ability（PAM-13）
时间窗: at baseline and at 1, 3, and 6 months post-intervention
Self-management ability is measured using the Patient Activation Measure (PAM-13) developed by Hibbard et al. (2005). The PAM-13 consists of 13 items assessing an individual's knowledge, skills, and confidence in managing their health or chronic condition. Each item is rated on a 4-point Likert scale, and raw scores are transformed into a standardized score ranging from 0 to 100, with higher scores indicating greater self-management ability and willingness to engage in self-care. The Chinese version of the PAM-13 has demonstrated good internal consistency, with a Cronbach's alpha of 0.835.
次要结局
- Quality of Life Related to EGFR-TKI Treatment（FACT-EGFRI-18）(at baseline and at 1, 3, and 6 months post-intervention)
- Overall User Satisfaction With the LINE Chatbot Intervention (CSQ-8)(At 3 months after the intervention)
- Quality of Life Related to EGFR-TKI Treatment（FACT-EGFRI-18）(at baseline and at 1, 3, and 6 months post-intervention)
- Overall User Satisfaction With the LINE Chatbot Intervention (CSQ-8)(At 3 months after the intervention)