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Набор скоро начнётся NCT07495358

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

Без фазы С лечением Breast Neoplasms Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Knowledge Graph-Based Symptom Management System.
Кому может быть актуально
Состояния в реестре: Breast Neoplasms, Syndrome. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • mHealth App Usability Questionnaire [Срок оценки: At the end of the study period (approximately 6-8 weeks after system use)]
  • Post-Study System Usability Questionnaire [Срок оценки: At the end of the study period (approximately 6-8 weeks after system use)]
Вторичные конечные точки (6)
  • MD Anderson Symptom Inventory [Срок оценки: At baseline and at the end of the study period (approximately 6-8 weeks after system use)]
  • Average session duration per use [Срок оценки: Up to 12 weeks]
  • Number of system uses per week [Срок оценки: Up to 12 weeks]
  • Number of completed symptom reports [Срок оценки: Up to 12 weeks]
  • Semi-structured interviews (patient experience and satisfaction) [Срок оценки: At the end of the study period (approximately 6-8 weeks after system use)]
  • Task-based usability assessment [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07495358 · KG-SMR-BC-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗