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

Официальное название

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

Обзор

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).

Вмешательства

• Устройство 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.
• Поведенческое 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.

Первичные конечные точки

• Depression [Срок оценки: 24weeks]
• anxiety [Срок оценки: 24weeks]

Вторичные конечные точки (5)

• Quality of Life (QoL) [Срок оценки: 24weeks]
• PRO-CTCAE [Срок оценки: 24weeks]
• Medication Adherence [Срок оценки: 24weeks]
• Overall Survival(OS) [Срок оценки: 2years]
• Progression-Free Survival (PFS) [Срок оценки: 2years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• Tianjin Medical University Cancer Institute & Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07409298 · E20251024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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