Impact of an Artificial Intelligence-Based Management Model on Psychological and Behavioral Outcomes in Breast Cancer Patients Undergoing Home CDK4/6 Inhibitor Therapy

Enrolling by invitation · Not applicable

Conditions studied: CDK4/6 Inhibitors, Depression Anxiety Disorder, Breast Cancer

In brief

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).

Key facts

Study ID

NCT07409298

Run by

Tianjin Medical University Cancer Institute and Hospital

People needed

300

Starts

2025-07-05

Expected to finish

2026-05-30

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China

Full record on ClinicalTrials.gov

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