Developing and Testing the Efficacy of AI-Chatbot-Based Delivering Body-Mind- Spirit Integrated With Mindfulness Compassion Therapy in Improving Holistic Well-being and Depression for Breast Cancer Survivors: A Large-scale Multi-sites Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-9, PHQ-9
研究概览
简要总结
this study aims to develop the Calm-Mind-Recovery-Journey AI-Chatbot delivering BMS-MC therapy for breast cancer survivors and examine its feasibility, acceptability, safety, and preliminary effects of holistic well-being and depressive levels, and coping skills (mindfulness status, self-compassion, emotional regulations), and breast cancer-specific QOL. The experiences of participants using AI-Chatbot will be explored.
详细描述
For the first and the second years, Phase I using retrieval-augmented generation (RAG), developing a rule-based "CalmRecoveryJourney" AI-Chatbot step to step guided BMS-MC, feedback system, 24-hour emotional support with human-loop escalation. Phase II Pilot evaluation using a mixed-methods design including the quantitative (a randomized waitlist-controlled trial, RCT) and qualitative methods (in-depth interview) in the 68 breast cancer survivors who completed active cancer treatments and will be recruited from breast cancer organizations, and social media. For the third year, a large-scale single-arm intervention with three repeated measurements (baseline, post-intervention, and follow-up) will be conducted across four geographic regions in Taiwan (North, Central, South, and East). A total of 200 breast cancer survivors from four regions will be recruited. The outcome measures include self-report questionnaires (WHO Well-Being Index and Patient Health Questionnaire-9, PHQ-9, Emotion Regulation Questionnaire, Five Facet Mindfulness Questionnaire, self-compassion scale, EORTC QLQ-BR45, wearable EEG online data and survivors' learning process data from the AI-Chabot system including adherence and engagement with AI-Chatbot. Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3). With intentional-to-treat GEE analysis and thematic qualitative analysis will be conducted.
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
- Double (Care Provider, Outcomes Assessor)
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
- •Diagnosis of breast cancer completing the active cancer treatments (surgery, chemotherapy, radiotherapy) Aged at least 20 Owned a smartphone (Android or iOS) with Line access Ability to communicate with the AI chatbot Willingness to participate in the research and interact with the AI-chatbot during the intervention.
排除标准
- •Diagnosis of another type of cancer Current receipt of psychotherapy Another online psychosocial or mental health intervention The presence of cognitive impairment or severe mental health conditions
结局指标
主要结局
Patient Health Questionnaire-9, PHQ-9
时间窗: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)
Unabbreviated Scale Title: Patient Health Questionnaire-9 Minimum and Maximum Values: 0 to 27 Outcome Direction: Higher scores indicate a worse outcome (greater severity of depressive symptoms).
WHO Well-Being Index
时间窗: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).
Unabbreviated Scale Title: World Health Organization-Five Well-Being Index Minimum and Maximum Values: 0 to 25 (often converted to a percentage score from 0 to 100 by multiplying the raw score by 4) Outcome Direction: Higher scores indicate a better outcome (higher level of well-being).
次要结局
- Emotion Regulation Questionnaire(Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3))
- Five Facet Mindfulness Questionnaire(Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).)
- self-compassion scale(Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).)
- EORTC QLQ-BR45(Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3))
- wearable EEG power in alpha band(Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3))
研究者
National Taiwan University Clinical Trial Center
Professor
National Taiwan University Hospital