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Enrolling by invitation NCT07409298

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

No phase Interventional CDK4/6 Inhibitors Depression Anxiety Disorder Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The "Zhiliao Doctor" AI management platform, Tailored Active Follow-up Strategy.
Who it may be relevant to
Registry conditions: CDK4/6 Inhibitors, Depression Anxiety Disorder, Breast Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

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.

Primary outcome measures

  • Depression [Time frame: 24weeks]
  • anxiety [Time frame: 24weeks]
Secondary outcome measures (5)
  • Quality of Life (QoL) [Time frame: 24weeks]
  • PRO-CTCAE [Time frame: 24weeks]
  • Medication Adherence [Time frame: 24weeks]
  • Overall Survival(OS) [Time frame: 2years]
  • Progression-Free Survival (PFS) [Time frame: 2years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute & Hospital — Tianjin

Identifiers

NCT: NCT07409298 · E20251024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗