Application of BaiXiaoAi Companion AI in the Diagnosis, Treatment, and Follow-up Management of Oncology Patients: A Single-Center, Prospective, Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Accuracy and safety of AI-assisted patient communication
研究概览
简要总结
This is a prospective, single-center, exploratory study designed to evaluate the accuracy, user engagement, and user experience of the BaiXiaoAi Companion AI. Upon signing the informed consent form and enrollment, a dedicated "Doctor-Nurse-Patient-AI" WeChat group will be established for each participant. Within the group, the BaiXiaoAi AI will provide timely responses based on patient communications and proactively push information regarding disease management and patient education.
详细描述
This is a prospective, single-center, exploratory clinical study aiming to comprehensively assess the diagnostic accuracy, user engagement efficacy, and subjective user experience of the BaiXiaoAi Companion AI system in the context of clinical patient management.
Following the voluntary signing of the informed consent document and formal enrollment into the study cohort, each participant will be assigned to a dedicated WeChat group adopting a "Doctor-Nurse-Patient-AI" quadruple collaborative model. Within this closed communication platform, the BaiXiaoAi Companion AI is programmed to perform two core functions: first, it delivers real-time, contextually tailored responses to patients' inquiries, symptom descriptions, and daily health-related communications shared within the group; second, it proactively disseminates personalized, evidence-based content covering disease-specific management protocols, medication adherence guidance, lifestyle modification recommendations, and targeted patient education materials. These interventions are designed to facilitate seamless interaction between medical providers and patients while leveraging AI-driven tools to augment the continuity of care outside of traditional clinical settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults aged 18 years or older;
- •Patients with a confirmed diagnosis of malignant neoplasms who are currently undergoing treatment or in follow-up, or their primary caregivers;
- •Able to read and communicate in Chinese and independently use WeChat;
- •Willing and able to provide informed consent.
排除标准
- •Presence of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) or cognitive impairment (MMSE score < 24);
- •Inability to use WeChat or communicate in Chinese;
- •Considered by the investigators to be unsuitable for participation due to psychological or physical conditions.
研究组 & 干预措施
Total Study Population
This is an observational study with no predefined study groups
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Accuracy and safety of AI-assisted patient communication
时间窗: Up to 12 months
The accuracy and safety of the AI-assisted communication tool will be assessed by monitoring the occurrence and severity of AI-related safety events during the study period. Safety events include misinformation, misunderstanding, inappropriate emotional responses, or potential risks related to medical decision-making attributable to the AI tool. Events are classified into four levels (Grade 0-3), where Grade 0 indicates no issue and Grade 3 indicates a serious error with potential medical risk.
次要结局
未报告次要终点
研究者
NING_LI
Chief, Office of Clinical Trial Center, CancerIHCAMS
Cancer Institute and Hospital, Chinese Academy of Medical Sciences