Impact of an Artificial Intelligence-Based Management Model on Psychological and Behavioral Outcomes in Breast Cancer Patients Undergoing Home CDK4/6 Inhibitor Therapy: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
This version uses full terminology and flows well for a research proposal or paper.
Primary Objective: To compare the intervention effects of an "AI-based management model," a "customized active follow-up model," and a "conventional patient education and follow-up model" on anxiety and depression in patients.
Secondary Objectives: To evaluate the impact of these models on patients' quality of life (QoL), patient-reported adverse events, medication adherence, serological markers, progression-free survival (PFS), and overall survival (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females aged ≥ 18 years, regardless of menopausal status.
- •Diagnosis of HR+/HER2- breast cancer.
- •Currently receiving or scheduled to receive CDK4/6 inhibitor therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •No history of severe psychiatric disorders (e.g., bipolar disorder, schizophrenia).
- •Baseline psychological state sufficient to understand and participate in psychological interventions.
- •Currently engaged in a rehabilitation plan, including exercise therapy and physical therapy.
- •Willingness to provide written informed consent.
- •Capability to perform online operations via smartphone or computer.
排除标准
- •Severe complications (e.g., heart disease, severe hepatic or renal dysfunction) that render the patient unable to tolerate CDK4/6i therapy.
- •History of severe psychiatric illness (e.g., severe depression, bipolar disorder, or schizophrenia) that precludes self-assessment.
- •Other malignant tumors within the past 5 years (excluding specific cured carcinomas).
- •Pregnant or breastfeeding women.
- •Positive baseline pregnancy test for women of childbearing potential.
- •Inability to adapt to or intolerance of the AI virtual doctor's intervention formats.
- •Any other condition that the investigator deems unsuitable for participation in the study.
研究组 & 干预措施
Group A: AI-integrated Care Mode
On the basis of routine follow-up, the 'Zhiliao Doctor' AI management platform is utilized to provide intelligent services, including emotional companionship, medication reminders, and adverse reaction assessment and guidance.
干预措施: The "Zhiliao Doctor" AI management platform (Device)
Group B: Tailored Active Follow-up Strategy
Receiving personalized active follow-up services, such as phone calls and text messages, provided by the follow-up center.
干预措施: Tailored Active Follow-up Strategy (Behavioral)
Group C: Standard Patient Education and Follow-up
Patients receive routine medical advice and patient education.
结局指标
主要结局
Depression
时间窗: 24weeks
Depression is evaluated using the Self-rating Depression Scale (SDS). The SDS consists of 20 items, with each item scored on a 4-point scale ranging from 1 to 4. The raw total score is calculated by summing the scores of all items and is then converted into a standard score. The cutoff value for the standard score is set at 50. Higher scores indicate a greater severity of depression.
anxiety
时间窗: 24weeks
Anxiety is evaluated using the Self-rating Anxiety Scale (SAS). The scale consists of 20 items, with each item scored on a 4-point scale ranging from 1 to 4. The raw total score is obtained by summing the scores of all individual items and is subsequently converted into a standard score. The threshold for the standard score is 50. Higher scores reflect a greater severity of anxiety.
次要结局
- PRO-CTCAE(24weeks)
- Quality of Life (QoL)(24weeks)
- Medication Adherence(24weeks)
- Overall Survival(OS)(2years)
- Progression-Free Survival (PFS)(2years)
研究者
Li Zhang (breast cancer)
Associate Chief Physician
Tianjin Medical University Cancer Institute and Hospital