Development and Usability Evaluation of a Knowledge Graph-Based Symptom Management Recommendation System for Patients With Breast Cancer Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- mHealth App Usability Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years
- •Pathologically confirmed breast cancer
- •Stage I-III breast cancer
- •Planning to initiate or currently receiving neoadjuvant or adjuvant chemotherapy
- •Expected to continue chemotherapy during the study period and complete at least two treatment time points/cycles
- •Able and willing to provide informed consent
- •Able to complete basic smartphone operations and system tasks independently or with guidance from the research staff
排除标准
- •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
结局指标
主要结局
mHealth App Usability Questionnaire
时间窗: At the end of the study period (approximately 6-8 weeks after system use)
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
时间窗: At the end of the study period (approximately 6-8 weeks after system use)
Usability of the knowledge graph-based symptom management system assessed using a standardized mHealth usability questionnaire, including ease of use, usefulness, and user satisfaction.
次要结局
- MD Anderson Symptom Inventory(At baseline and at the end of the study period (approximately 6-8 weeks after system use))
- Average session duration per use(Up to 12 weeks)
- Number of system uses per week(Up to 12 weeks)
- Number of completed symptom reports(Up to 12 weeks)
- Semi-structured interviews (patient experience and satisfaction)(At the end of the study period (approximately 6-8 weeks after system use))
- Task-based usability assessment(Baseline)
研究者
Ruolin Li
Principal Investigator
Capital Medical University