An interventional study of Knowledge Graph-Based Symptom Management System in Breast Neoplasms and Syndrome, sponsored by Capital Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Capital Medical University · Not applicable, Interventional, and Supportive care
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Capital Medical University is the lead sponsor of 295 studies on the registry; 91 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Knowledge 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.
mHealth App Usability Questionnaire
System usability assessed using the System Usability Scale (SUS), a validated 10-item questionnaire evaluating overall usability of the system.
Time frame: 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.
Time frame: At the end of the study period (approximately 6-8 weeks after system use)
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.
Time frame: At baseline and at the end of the study period (approximately 6-8 weeks after system use)
Average session duration per use
The average duration of each system use session per participant, recorded automatically via system logs.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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.
Time frame: Throughout the study period (approximately 6-8 weeks)
No study locations are listed for this record.
Plan to share: No — Data available upon reasonable request
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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