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NCT Number: NCT07495358

Development and Usability Evaluation of a Knowledge Graph-Based Symptom Management 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. MD Anderson Symptom Inventory

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

    Symptom severity and interference assessed using the MD Anderson Symptom Inventory (MDASI), a validated instrument measuring multiple symptoms in patients with cancer.

  2. Average session duration per use

    Time frame: Up to 12 weeks

    The average duration of each system use session per participant, recorded automatically via system logs.

  3. Number of system uses per week

    Time frame: Up to 12 weeks

    The number of times each participant accesses the system per week, recorded automatically via system logs

  4. Number of completed symptom reports

    Time frame: Up to 12 weeks

    The total number of symptom reports submitted by each participant through the system, recorded automatically via system logs.

  5. Semi-structured interviews (patient experience and satisfaction)

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

    Patient experience and satisfaction explored through semi-structured interviews, focusing on usability, perceived usefulness, and barriers to system use.

  6. Task-based usability assessment

    Time frame: Baseline

    Task-based usability assessment evaluating users' ability to complete predefined tasks, including task completion rate, time on task, and error rate.

Other outcomes

  1. Adverse events and safety monitoring

    Time frame: Throughout the study period (approximately 6-8 weeks)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun-E Liu, Prof.

CONTACT

[email protected]

Ruolin Li, MS

CONTACT

[email protected]

+8615909837326

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Acronym: KG-SMR-BC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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