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.
Aged 18 to 80 years
Pathologically confirmed breast cancer
Stage I-III breast cancer
Planning to initiate or currently receiving neoadjuvant or adjuvant chemotherapy
Recurrent or metastatic breast cancer (stage IV)
Significant cognitive impairment or communication barriers that preclude informed consent or completion of study procedures
Severe psychiatric disorders or unstable psychiatric symptoms that may interfere with study participation
Considered unsuitable for participation by the clinical or research team because of unstable medical condition or need for acute management
Single group
Knowledge Graph-Based Symptom Management System
BehavioralThe 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.
mHealth App Usability Questionnaire
System usability assessed using the System Usability Scale (SUS), a validated 10-item questionnaire evaluating overall usability of the system.
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.
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.
Average session duration per use
The average duration of each system use session per participant, recorded automatically via system logs.
Number of system uses per week
The number of times each participant accesses the system per week, recorded automatically via system logs
Number of completed symptom reports
The total number of symptom reports submitted by each participant through the system, recorded automatically via system logs.
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.
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