Breast Cancer, CDK4/6 Inhibitors, Depression Anxiety Disorder
Conditions
Keywords
AI-based Management Model, Customized Follow-up Mode, Psychological Intervention
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).
Interventions
BEHAVIORALTailored Active Follow-up Strategy
Participants receive tailored active follow-up, including personalized phone calls and SMS messages, managed by a professional follow-up center.
DEVICEThe "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.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University General Hospital
Tianjin First Central Hospital
Tianjin Medical University Second Hospital
Tianjin People's Hospital
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin Third Central Hospital
Tianjin Fifth Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 24weeks | 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. |
| anxiety | 24weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) | 24weeks | 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. |
| PRO-CTCAE | 24weeks | 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. |
| Medication Adherence | 24weeks | 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%. |
| Overall Survival(OS) | 2years | — |
| Progression-Free Survival (PFS) | 2years | — |
Countries
China
Outcome results
None listed