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

Status: Invitation-only

Conditions: Breast Cancer; Depression Anxiety Disorder; CDK4/6 Inhibitors

Treatments: Behavioral: Tailored Active Follow-up Strategy; Device: The "Zhiliao Doctor" AI management platform

Study type: Interventional

Funder types: Other

Identifiers

NCT07409298

E20251024

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 3 patient groups

Group A: AI-integrated Care Mode

Experimental group

Description:

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.

Treatment:

Device: The "Zhiliao Doctor" AI management platform

Group B: Tailored Active Follow-up Strategy

Experimental group

Description:

Receiving personalized active follow-up services, such as phone calls and text messages, provided by the follow-up center.

Treatment:

Behavioral: Tailored Active Follow-up Strategy

Group C: Standard Patient Education and Follow-up

No Intervention group

Description:

Patients receive routine medical advice and patient education.