Breast Neoplasms, Syndrome
Conditions
Keywords
breast cancer, symptom management, chemotherapy, recommender system
Brief summary
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.
Interventions
BEHAVIORALKnowledge Graph-Based Symptom Management System
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.
Sponsors
Capital Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mHealth App Usability Questionnaire | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MD Anderson Symptom Inventory | At baseline and at the end of the study period (approximately 6-8 weeks after system use) | 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 | Up to 12 weeks | The average duration of each system use session per participant, recorded automatically via system logs. |
| Number of system uses per week | Up to 12 weeks | The number of times each participant accesses the system per week, recorded automatically via system logs |
| Number of completed symptom reports | Up to 12 weeks | The total number of symptom reports submitted by each participant through the system, recorded automatically via system logs. |
| Semi-structured interviews (patient experience and satisfaction) | At the end of the study period (approximately 6-8 weeks after system use) | Patient experience and satisfaction explored through semi-structured interviews, focusing on usability, perceived usefulness, and barriers to system use. |
| Task-based usability assessment | Baseline | Task-based usability assessment evaluating users' ability to complete predefined tasks, including task completion rate, time on task, and error rate. |
Contacts
CONTACTRuolin Li, MS
CONTACTJun-E Liu, Prof.
Outcome results
None listed