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

Not Applicable

Not yet recruiting

• Conditions: Radiation-Induced Mucositis; Head and Neck Cancer

• Registration Number: NCT07126457
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-10
• Study First Submitted QC: 2025-08-10
• Last Update Submitted: 2025-08-10
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Study Start: 2025-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Voluntarily sign the informed consent form;
2. Reached the age of 18 on the date of signing the informed consent form, and under the age of 65;
3. Patients diagnosed with head and neck tumors and receiving radiotherapy as per the 2017 WHO standards and guidelines.
4. According to the doctor's assessment, patients may experience radiation-induced oropharyngeal mucositis during radiotherapy.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the satisfaction of patients	Through study completion, up to 3 years	We use the patient satisfaction scale designed by us for the information age to assess patients' satisfaction during the diagnosis and treatment period.

Secondary Outcome Measures

Name	Time	Method
The response rate of the processing	Through study completion, up to 3 years	The proportion of questions raised by the patients that were answered
The compliance rate of patients following the recommendations	Through study completion, up to 3 years	The proportion of patients who followed the response advice and actually carried out the suggested actions
Evaluation of response validity	Through study completion, up to 3 years	The effectiveness score of the responses received to the patient's questions
Doctor satisfaction	Through study completion, up to 3 years	The satisfaction of doctors in the patient management process

Trial Locations

Locations (4)

Nanfang hospital, Southern medical university; 🇨🇳 Guangzhou, Guangdong, China

Huizhou Central People's Hospital; 🇨🇳 Huizhou, Guangdong, China

Jieyang people's hospital; 🇨🇳 Jieyang, Guangdong, China

Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou; 🇨🇳 Meizhou, Guangdong, China