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
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: RIS system.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Radiation-Induced Mucositis. Basic parameters: 18 years — 65 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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.
Primary outcome measures
- the satisfaction of patients [Time frame: Through study completion, up to 3 years]
Secondary outcome measures (4)
- The response rate of the processing [Time frame: Through study completion, up to 3 years]
- Evaluation of response validity [Time frame: Through study completion, up to 3 years]
- The compliance rate of patients following the recommendations [Time frame: Through study completion, up to 3 years]
- Doctor satisfaction [Time frame: Through study completion, up to 3 years]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 4 centers
- Nanfang hospital, Southern medical university — Guangzhou
- Huizhou Central People's Hospital — Huizhou
- Jieyang people's hospital — Jieyang
- Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou — Meizhou
Identifiers
NCT: NCT07126457 · NFEC-2025-231