Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 6:19 PM
Study NCT ID:
NCT07126457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Nanfang Hospital, Southern Medical University
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: