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

NCT07409298 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-02-13

No results posted yet for this 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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Tianjin Medical University General Hospital

    collaborator OTHER

  • Tianjin First Central Hospital

    collaborator OTHER

  • Tianjin Medical University Second Hospital

    collaborator OTHER

  • Tianjin People's Hospital

    collaborator OTHER

  • First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Tianjin Third Central Hospital

    collaborator OTHER

  • Tianjin Fifth Central Hospital

    collaborator UNKNOWN

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-05
Primary Completion
2026-05-24
Completion
2026-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07409298 on ClinicalTrials.gov