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

N/AEnrolling By InvitationNCT07409298

Tianjin Medical University Cancer Institute and Hospital300 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

300

Conditions

CDK4/6 Inhibitors Depression Anxiety Disorder Breast Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 24weeks

Secondary Outcomes

Quality of Life (QoL)

The EORTC QLQ-C30 consists of five functional scales (physical, role, cognitive, emotional, and social), a global QoL scale, three symptom scales (fatigue, nausea and vomiting, and pain), single items assessing common symptoms (dyspnoea, loss of appetite, insomnia, constipation, and diarrhoea), and a single item assessing the perceived financial impact. After linear transformation, all scales and single-item measures range in score from 0 to 100. A higher score for a functional scale and the global QoL scale represents a higher level of functioning and a higher level of HRQoL. Conversely, a higher score for a symptom scale or item and the financial impact item indicates a higher level of symptom burden or financial impact.

Time frame: 24weeks

PRO-CTCAE

The PRO-CTCAE is a validated library of patient-reported items designed to measure 78 distinct symptomatic adverse events (AEs). For each AE, up to three separate attribute items assess the frequency, severity, and interference with daily activities over the past 7 days. Scores for each attribute can be reported individually or integrated into a single composite score ranging from 0 to 3 for each symptom using established algorithms. Higher individual or composite scores indicate greater symptom severity. Relevant PRO-CTCAE items are typically selected for a specific clinical trial based on prior evidence and/or the mechanism of action, and then compiled into a survey. In this trial, investigators selected 10 PRO-CTCAE symptoms based on CDK4/6 inhibitor-related side effects reported in the literature. The selected symptoms include: decreased appetite, nausea, constipation, diarrhea, dizziness, pain, insomnia, fatigue, dejection, and sadness.

Time frame: 24weeks

Medication Adherence

This study utilizes the Proportion of Days Covered (PDC) as a quantitative indicator of medication adherence. The formula is as follows: PDC = Number of days covered by medication during the observation period/Total number of days in the observation period× 100%.In this study, "high adherence" is defined as a PDC≥80%.

Time frame: 24weeks

Overall Survival(OS)

Time frame: 2years

Progression-Free Survival (PFS)

Time frame: 2years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes