Impact of an Artificial Intelligence-Based Management Model on Psychological and Behavioral Outcomes in Breast Cancer Patients Undergoing Home CDK4/6 Inhibitor Therapy
Tianjin Medical University Cancer Institute and Hospital
Phase
Not applicable
Started
2025-07-05
Last updated
2026-02-13
Condition(s) studied
CDK4/6 InhibitorsDepression Anxiety DisorderBreast Cancer
Investigational drug(s) / intervention(s)
The "Zhiliao Doctor" AI management platformTailored Active Follow-up Strategy
The "Zhiliao Doctor" AI management platform: Participants in Group A will receive standard clinical care supplemented by the 'Zhiliao Doctor' AI management platform. This 24/7 intelligent platform provides emotional companionship, medication reminders, and adverse reaction assessment based on CTCAE standards to enhance self-management and quality of life.
Tailored Active Follow-up Strategy: Participants receive tailored active follow-up, including personalized phone calls and SMS messages, managed by a professional follow-up center.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 0-2.
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Depression — 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 — 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.
Trial sites (1)
Facility
City
Region
Status
Tianjin Medical University Cancer Institute & Hospital
Tianjin
China
More Tianjin Medical University Cancer Institute and Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.