Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| CDK4/6 Inhibitors | — | UNRESOLVED | — |
| Depression Anxiety Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tailored Active Follow-up Strategy | Behavioral | — | UNRESOLVED |
| The "Zhiliao Doctor" AI management platform | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group A: AI-integrated Care Mode
- description
- 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.
- interventionNames
- Device: The "Zhiliao Doctor" AI management platform
- type
- EXPERIMENTAL
- label
- Group B: Tailored Active Follow-up Strategy
- description
- Receiving personalized active follow-up services, such as phone calls and text messages, provided by the follow-up center.
- interventionNames
- Behavioral: Tailored Active Follow-up Strategy
- type
- NO_INTERVENTION
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available