A Randomized Controlled Study on the Improvement of Medical Experience for Patients With Radiation-induced Oropharyngeal Mucositis Based on the RIS System of the Internet of Things
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: RIS system.
- Кому может быть актуально
- Состояния в реестре: Head and Neck Cancer, Radiation-Induced Mucositis. Базовые параметры: 18 лет — 65 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study is a researcher-initiated, multi-center, prospective, two-arm interventional randomized controlled study across the country. It aims to explore whether an Internet of Things-based RIS system can enhance the medical experience of patients with radiation-induced oropharyngeal mucositis during the diagnosis and treatment process among head and neck cancer patients undergoing radiotherapy.
Подробное описание
After signing the informed consent form, patients who meet the inclusion/exclusion criteria will be randomly assigned in a 1:1 ratio to the experimental group (using the RIS system group) and the control group (not using the RIS system group), with a total of 110 patients recruited.
Subjects randomized to the experimental group will be managed and followed up using the RIS system based on Internet of Things technology from the start of radiotherapy until one year after radiotherapy.
Subjects randomized to the control group will be treated and followed up using the current clinical routine management model.
The treatment period refers to the time from the start of radiotherapy to one month after the end of radiotherapy. During this period, patients are treated according to the standard treatment methods for head and neck malignancies (concurrent chemoradiotherapy, induction chemotherapy followed by concurrent chemoradiotherapy, or radiotherapy alone, chemotherapy alone). In the experimental group, the RIS system is used for auxiliary management. After the start of radiotherapy, the three modules of the system (one-way output module, two-way interaction module, and public science popularization module) are used to manage patients until the end of the treatment period. The one-way output module management mainly transmits information to patients through the database, providing them with relevant suggestions such as precautions and psychological counseling. The two-way interaction module management mainly conducts interactive information exchange through artificial intelligence programs, providing patients with personalized and real-time life advice or precautions. The public science popularization module conducts science popularization education for the public and patients through popular science works.
Вмешательства
- Другое RIS system
The RIS system based on the Internet of Things consists of three aspects: one-way output management of the large database of head and neck tumors, two-way interaction management of artificial intelligence applications, and popular science dissemination for the general public.
Первичные конечные точки
- the satisfaction of patients [Срок оценки: Through study completion, up to 3 years]
Вторичные конечные точки (4)
- The response rate of the processing [Срок оценки: Through study completion, up to 3 years]
- Evaluation of response validity [Срок оценки: Through study completion, up to 3 years]
- The compliance rate of patients following the recommendations [Срок оценки: Through study completion, up to 3 years]
- Doctor satisfaction [Срок оценки: Through study completion, up to 3 years]
Критерии участия
Критерии включения
- Voluntarily sign the informed consent form;
- Reached the age of 18 on the date of signing the informed consent form, and under the age of 65;
- Patients diagnosed with head and neck tumors and receiving radiotherapy as per the 2017 WHO standards and guidelines.
- According to the doctor's assessment, patients may experience radiation-induced oropharyngeal mucositis during radiotherapy.
Критерии исключения
- Have other uncontrolled serious diseases, such as unstable heart diseases requiring treatment, poorly controlled diabetes (fasting blood sugar > 1.5 times the upper limit of the normal value), mental disorders, and a severe history of allergies.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Китай · 4 центра
- Nanfang hospital, Southern medical university — Гуанчжоу
- Huizhou Central People's Hospital — Huizhou
- Jieyang people's hospital — Jieyang
- Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou — Meizhou
Идентификаторы
NCT: NCT07126457 · NFEC-2025-231