Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-28 @ 6:49 AM
Study NCT ID:
NCT07126457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-08-10
Is 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2025-08-10', 'studyFirstSubmitQcDate': '2025-08-10', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the satisfaction of patients', 'timeFrame': 'Through study completion, up to 3 years', 'description': "We use the patient satisfaction scale designed by us for the information age to assess patients' satisfaction during the diagnosis and treatment period."}], 'secondaryOutcomes': [{'measure': 'The response rate of the processing', 'timeFrame': 'Through study completion, up to 3 years', 'description': 'The proportion of questions raised by the patients that were answered'}, {'measure': 'Evaluation of response validity', 'timeFrame': 'Through study completion, up to 3 years', 'description': "The effectiveness score of the responses received to the patient's questions"}, {'measure': 'The compliance rate of patients following the recommendations', 'timeFrame': 'Through study completion, up to 3 years', 'description': 'The proportion of patients who followed the response advice and actually carried out the suggested actions'}, {'measure': 'Doctor satisfaction', 'timeFrame': 'Through study completion, up to 3 years', 'description': 'The satisfaction of doctors in the patient management process'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiation oropharyngeal mucositis', 'Head and Neck Cancer', 'Internet of things'], 'conditions': ['Head and Neck Cancer', 'Radiation-Induced Mucositis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSubjects 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.\n\nSubjects randomized to the control group will be treated and followed up using the current clinical routine management model.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form;\n2. Reached the age of 18 on the date of signing the informed consent form, and under the age of 65;\n3. Patients diagnosed with head and neck tumors and receiving radiotherapy as per the 2017 WHO standards and guidelines.\n4. According to the doctor's assessment, patients may experience radiation-induced oropharyngeal mucositis during radiotherapy.\n\nExclusion Criteria:\n\n* 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."}, 'identificationModule': {'nctId': 'NCT07126457', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NFEC-2025-231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'Use the RIS system', 'interventionNames': ['Other: RIS system']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Do not use the ris system'}], 'interventions': [{'name': 'RIS system', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang hospital, Southern medical university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '516000', 'city': 'Huizhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Huizhou Central People's Hospital", 'geoPoint': {'lat': 23.11147, 'lon': 114.41523}}, {'zip': '522000', 'city': 'Jieyang', 'state': 'Guangdong', 'country': 'China', 'facility': "Jieyang people's hospital", 'geoPoint': {'lat': 23.5418, 'lon': 116.36581}}, {'zip': '514000', 'city': 'Meizhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou", 'geoPoint': {'lat': 24.28859, 'lon': 116.11768}}], 'centralContacts': [{'name': 'Jian Guan, M.D', 'role': 'CONTACT', 'email': 'guanjian5461@163.com', 'phone': '+86-13632102247'}], 'overallOfficials': [{'name': 'Jian Guan, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}