Development and Usability Evaluation of a Knowledge Graph-Based Symptom Management System for Patients With Breast Cancer Undergoing Chemotherapy (KG-SMR-BC)

Capital Medical University

Status: Not yet enrolling

Conditions: Breast Neoplasms; Syndrome

Treatments: Behavioral: Knowledge Graph-Based Symptom Management System

Study type: Interventional

Funder types: Other

Identifiers

NCT07495358

KG-SMR-BC-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Knowledge Graph-Based Symptom Management Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Knowledge Graph-Based Symptom Management System