Breast NeoplasmsKG-SMR-BCNCT07495358
Development and Usability Evaluation of a Knowledge Graph-Based Symptom Management System for Patients With Breast Cancer Undergoing Chemotherapy
A study testing Knowledge Graph-Based Symptom Management System in people with Breast Neoplasms and Syndrome, run by Capital Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Neoplasms, Syndrome
- What is being tested?
- Knowledge Graph-Based Symptom Management System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jun-E Liu, Prof. contact
About this study
Official title: Development and Usability Evaluation of a Knowledge Graph-Based Symptom Management Recommendation System for Patients With Breast Cancer Undergoing Chemotherapy
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.
Read more
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.
- Conditions
- Breast Neoplasms, Syndrome
- Being tested
- Knowledge Graph-Based Symptom Management System
- Keywords
- breast cancer, symptom management, chemotherapy, recommender system
- Medical subject headings
- Breast Neoplasms, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge Graph-Based Symptom Management SystemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Knowledge Graph-Based Symptom Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
mHealth App Usability Questionnaire
System usability assessed using the System Usability Scale (SUS), a validated 10-item questionnaire evaluating overall usability of the system.
Measured: 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.
Measured: At the end of the study period (approximately 6-8 weeks after system use)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruolin Li, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495358
- Sponsor's protocol ID
- KG-SMR-BC-01
- Acronym
- KG-SMR-BC
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Usability Evaluation of a Knowledge Graph-Based Symptom Management Recommendation System for Patients With Breast Cancer Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07495358
- Acronym / sponsor ID
- KG-SMR-BC / KG-SMR-BC-01
- Conditions
- Breast Neoplasms, Syndrome
- Keywords
- breast cancer, symptom management, chemotherapy, recommender system
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Knowledge Graph-Based Symptom Management Intervention | Experimental | Behavioral: Knowledge Graph-Based Symptom Management SystemParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowledge Graph-Based Symptom Management SystemThe 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. | Behavioural | Knowledge Graph-Based Symptom Management Intervention |
Primary outcome
mHealth App Usability Questionnaire
Time frame: 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
Time frame: 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.
6 secondary outcomes
MD Anderson Symptom Inventory
Time frame: At baseline and at the end of the study period (approximately 6-8 weeks after system use)
Average session duration per use
Time frame: Up to 12 weeks
Number of system uses per week
Time frame: Up to 12 weeks
Number of completed symptom reports
Time frame: Up to 12 weeks
Semi-structured interviews (patient experience and satisfaction)
Time frame: At the end of the study period (approximately 6-8 weeks after system use)
Task-based usability assessment
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No. Data available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun-E Liu, Prof. contact
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge Graph-Based Symptom Management System in people with Breast Neoplasms and Syndrome, run by Capital Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruolin Li, MS (+8615909837326, rlli99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mHealth App Usability Questionnaire (time frame: At the end of the study period (approximately 6-8 weeks after system use)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.