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

NCT07495358 | Not Yet Recruiting

• 1 other identifier: KG-SMR-BC-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms; Syndrome

Keywords

breast cancer; symptom management; chemotherapy; recommender system

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• MD Anderson Symptom Inventory

  At baseline and at the end of the study period (approximately 6-8 weeks after system use)

• Average session duration per use

  Up to 12 weeks

• Number of system uses per week

  Up to 12 weeks

• Number of completed symptom reports

  Up to 12 weeks

• Semi-structured interviews (patient experience and satisfaction)

  At the end of the study period (approximately 6-8 weeks after system use)

Other Outcomes (1)

• Adverse events and safety monitoring

  Throughout the study period (approximately 6-8 weeks)

Study Arms (1)

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.

Behavioral: Knowledge Graph-Based Symptom Management System

Interventions

Knowledge Graph-Based Symptom Management System BEHAVIORAL

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.

Knowledge Graph-Based Symptom Management Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

MeSH Terms

Conditions

Breast Neoplasms; Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ruolin Li, MS

CONTACT

+8615909837326; rlli99@163.com

Jun-E Liu, Prof.

CONTACT

liujune66@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share