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Patients with breast cancer patients undergoing chemotherapy commonly experience multiple co-occurring symptoms that are dynamic, interrelated, and difficult to manage using conventional approaches. Existing symptom management strategies often fail to address the complexity and evolving nature of symptom experiences during treatment.
This study aims to develop a knowledge graph-based symptom management recommendation system for patients with breast cancer undergoing chemotherapy and to evaluate its usability and preliminary effectiveness among both patients and nurses. The system integrates evidence-based guidelines, clinical expertise, and patient-reported data to provide personalized recommendations for symptom management.
In this study, patients will use the system to report symptoms and receive tailored management recommendations, while nurses will use it to support clinical decision-making and symptom management. Usability, acceptability, and user experience will be assessed for both patients and nurses, and changes in symptom burden and management outcomes will be evaluated.
The findings are expected to inform the feasibility and optimization of multi-user digital health interventions for comprehensive symptom management in oncology care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knowledge Graph-Based Symptom Management Intervention | Experimental | Participants will use a knowledge graph-based symptom management system during chemotherapy. Patients will report symptoms and receive personalized management recommendations. Nurses will also use the system to support symptom management and clinical decision-making. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knowledge Graph-Based Symptom Management System | Behavioral | The intervention is a knowledge graph-based symptom management system designed for patients with breast cancer undergoing chemotherapy. The system integrates evidence-based guidelines, clinical expertise, and patient-reported data to generate personalized symptom management recommendations. Patients use the system to report symptoms and receive tailored management strategies. Nurses use the system to support clinical decision-making and provide symptom management guidance. The intervention aims to improve symptom management and support patient-centered care. |
| Measure | Description | Time Frame |
|---|---|---|
| mHealth App Usability Questionnaire | System usability assessed using the System Usability Scale (SUS), a validated 10-item questionnaire evaluating overall usability of the system. | At the end of the study period (approximately 6-8 weeks after system use) |
| Post-Study System Usability Questionnaire | Usability of the knowledge graph-based symptom management system assessed using a standardized mHealth usability questionnaire, including ease of use, usefulness, and user satisfaction. | At the end of the study period (approximately 6-8 weeks after system use) |
| Measure | Description | Time Frame |
|---|---|---|
| MD Anderson Symptom Inventory | Symptom severity and interference assessed using the MD Anderson Symptom Inventory (MDASI), a validated instrument measuring multiple symptoms in patients with cancer. | At baseline and at the end of the study period (approximately 6-8 weeks after system use) |
| Average session duration per use |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and safety monitoring | Adverse events and safety monitoring during the study period, including any physical discomfort, psychological distress, or other unintended effects related to system use. All adverse events will be recorded and reviewed by the research team, and participants with clinically concerning conditions will be referred to the clinical care team as appropriate. | Throughout the study period (approximately 6-8 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruolin Li, MS | Contact | +8615909837326 | rlli99@163.com | |
| Jun-E Liu, Prof. | Contact | liujune66@ccmu.edu.cn |
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Data available upon reasonable request
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This is a single-arm interventional study in which participants with early-stage breast cancer undergoing chemotherapy will use a knowledge graph-based symptom management system. Participants will report symptoms and receive personalized management recommendations through the system. Nurses will use the system to support symptom management and clinical decision-making. Usability, acceptability, and preliminary effectiveness will be evaluated.
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|
The average duration of each system use session per participant, recorded automatically via system logs. |
| Up to 12 weeks |
| Number of system uses per week | The number of times each participant accesses the system per week, recorded automatically via system logs | Up to 12 weeks |
| Number of completed symptom reports | The total number of symptom reports submitted by each participant through the system, recorded automatically via system logs. | Up to 12 weeks |
| Semi-structured interviews (patient experience and satisfaction) | Patient experience and satisfaction explored through semi-structured interviews, focusing on usability, perceived usefulness, and barriers to system use. | At the end of the study period (approximately 6-8 weeks after system use) |
| Task-based usability assessment | Task-based usability assessment evaluating users' ability to complete predefined tasks, including task completion rate, time on task, and error rate. | Baseline |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D013577 | Syndrome |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004194 | Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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