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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Syndrome; Breast Neoplasms
• Intervention / Treatment: Behavioral: Knowledge Graph-Based Symptom Management System

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruolin Li, MS; Phone Number: +8615909837326; Email: rlli99@163.com
• Study Contact Backup: Name: Jun-E Liu, Prof.; Email: liujune66@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Knowledge Graph-Based Symptom Management Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mHealth App Usability Questionnaire	System usability assessed using the System Usability Scale (SUS), a validated 10-item questionnaire evaluating overall usability of the system.	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.	At the end of the study period (approximately 6-8 weeks after system use)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	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.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Throughout the study period (approximately 6-8 weeks)

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 21, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; chemotherapy; symptom management; recommender system
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Syndrome; Breast Neoplasms
• Other Study ID Numbers: KG-SMR-BC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No