Head and Neck Cancer, Radiation-Induced Mucositis
Conditions
Keywords
Radiation oropharyngeal mucositis, Head and Neck Cancer, Internet of things
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.
Interventions
OTHERRIS 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The response rate of the processing | Through study completion, up to 3 years | The proportion of questions raised by the patients that were answered |
| Evaluation of response validity | Through study completion, up to 3 years | The effectiveness score of the responses received to the patient's questions |
| 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 |
| Doctor satisfaction | Through study completion, up to 3 years | The satisfaction of doctors in the patient management process |
Countries
China
Contacts
Primary ContactJian Guan, M.D
Outcome results
None listed