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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
| Tianjin First Central Hospital | OTHER |
| Tianjin Medical University Second Hospital | OTHER |
| Tianjin People's Hospital |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: AI-integrated Care Mode | Experimental | 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. |
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| Group B: Tailored Active Follow-up Strategy | Experimental | Receiving personalized active follow-up services, such as phone calls and text messages, provided by the follow-up center. |
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| Group C: Standard Patient Education and Follow-up | No Intervention | Patients receive routine medical advice and patient education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The "Zhiliao Doctor" AI management platform | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | 300000 | China |
Individual participant data (IPD) will not be shared primarily because the study involves highly sensitive psychological assessments (e.g., SAS and SDS scores) and detailed interaction logs with the "Zhiliao Doctor" AI platform; such unstructured data pose significant de-identification challenges and potential privacy risks. Additionally, the current institutional review board (IRB) approval and the informed consent forms signed by participants do not include provisions for the public sharing of individual-level raw data. Furthermore, as a multicenter study involving serological markers, data sharing is strictly limited by inter-institutional agreements, intellectual property protections, and national regulatory requirements for the management of human genetic resource data.
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| OTHER |
| The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | OTHER |
| Tianjin Third Central Hospital | OTHER |
| Tianjin Fifth Central Hospital | UNKNOWN |
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| Tailored Active Follow-up Strategy | Behavioral | Participants receive tailored active follow-up, including personalized phone calls and SMS messages, managed by a professional follow-up center. |
|
| 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. | 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%. | 24weeks |
| Overall Survival(OS) | 2years |
| Progression-Free Survival (PFS) | 2years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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