NCT07409298

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• CDK4/6 Inhibitors
• Depression Anxiety Disorder
• Breast Cancer

Interventions

Type	Name	Description
DEVICE	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-07-05
• Primary completion: 2026-05-24
• Completion: 2026-05-30
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: China