Clinical Trial

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

Record status

This record was last updated February 13, 2026 (before its estimated May 24, 2026 completion). Its status may not reflect the trial's current state.

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).

Trial Details

NCT Number	NCT07409298
Lead Sponsor	Tianjin Medical University Cancer Institute and Hospital Collaborators: Tianjin Medical University General Hospital, Tianjin First Central Hospital, Tianjin Medical University Second Hospital, Tianjin People's Hospital, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Third Central Hospital, Tianjin Fifth Central Hospital
Conditions	CDK4/6 Inhibitors, Depression Anxiety Disorder, Breast Cancer
Enrollment	300 participants
Start Date	2025-07-05
Primary Completion	2026-05-24 (estimated)
Study Completion	2026-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-13