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

NCT07409298 | Enrolling By Invitation

• 1 other identifier: E20251024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

AI-based Management Model; Customized Follow-up Mode; Psychological Intervention

Outcome Measures

Primary Outcomes (2)

• Depression

  Depression is evaluated using the Self-rating Depression Scale (SDS). The SDS consists of 20 items, with each item scored on a 4-point scale ranging from 1 to 4. The raw total score is calculated by summing the scores of all items and is then converted into a standard score. The cutoff value for the standard score is set at 50. Higher scores indicate a greater severity of depression.

  24weeks

• anxiety

  Anxiety is evaluated using the Self-rating Anxiety Scale (SAS). The scale consists of 20 items, with each item scored on a 4-point scale ranging from 1 to 4. The raw total score is obtained by summing the scores of all individual items and is subsequently converted into a standard score. The threshold for the standard score is 50. Higher scores reflect a greater severity of anxiety.

  24weeks

Secondary Outcomes (5)

• Quality of Life (QoL)

  24weeks

• PRO-CTCAE

  24weeks

• Medication Adherence

  24weeks

• Overall Survival(OS)

  2years

• Progression-Free Survival (PFS)

  2years

Study Arms (3)

Group A: AI-integrated Care Mode

EXPERIMENTAL

On the basis of routine follow-up, the 'Zhiliao Doctor' AI management platform is utilized to provide intelligent services, including emotional companionship, medication reminders, and adverse reaction assessment and guidance.

Device: The "Zhiliao Doctor" AI management platform

Group B: Tailored Active Follow-up Strategy

EXPERIMENTAL

Receiving personalized active follow-up services, such as phone calls and text messages, provided by the follow-up center.

Behavioral: Tailored Active Follow-up Strategy

Group C: Standard Patient Education and Follow-up

NO INTERVENTION

Patients receive routine medical advice and patient education.

Interventions

The "Zhiliao Doctor" AI management platform DEVICE

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.

Group A: AI-integrated Care Mode

Tailored Active Follow-up Strategy BEHAVIORAL

Participants receive tailored active follow-up, including personalized phone calls and SMS messages, managed by a professional follow-up center.

Group B: Tailored Active Follow-up Strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Tianjin Medical University General Hospital: collaborator
• Tianjin First Central Hospital: collaborator
• Tianjin Medical University Second Hospital: collaborator
• Tianjin People's Hospital: collaborator
• First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine: collaborator
• Tianjin Third Central Hospital: collaborator
• Tianjin Fifth Central Hospital: collaborator

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 300000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 13, 2026
• Study Start: July 5, 2025
• Primary Completion (Estimated): May 24, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CN (1)