Impact of an Artificial Intelligence-Based Management Model on Psychological and Behavioral Outco… (NCT07409298) | Clinical Trial Compass
By InvitationNot Applicable
Impact of an Artificial Intelligence-Based Management Model on Psychological and Behavioral Outcomes in Breast Cancer Patients Undergoing Home CDK4/6 Inhibitor Therapy
China300 participantsStarted 2025-07-05
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Depression
Timeframe: 24weeks
2
anxiety
Timeframe: 24weeks
Trial details
NCT IDNCT07409298
SponsorTianjin Medical University Cancer Institute and Hospital