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Not yet recruiting NCT07495358

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

No phase Interventional Breast Neoplasms Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Knowledge Graph-Based Symptom Management System.
Who it may be relevant to
Registry conditions: Breast Neoplasms, Syndrome. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • mHealth App Usability Questionnaire [Time frame: At the end of the study period (approximately 6-8 weeks after system use)]
  • Post-Study System Usability Questionnaire [Time frame: At the end of the study period (approximately 6-8 weeks after system use)]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07495358 · KG-SMR-BC-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗