Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-04-05 @ 8:17 AM
Study NCT ID:
NCT07305766
Status:
COMPLETED
Last Update Posted:
2025-12-26
First Post:
2025-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Construction and Preliminary Application of Evidence-Based Nursing Protocol for Oral Mucositis Related to Tumor Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D014456', 'term': 'Ulcer'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of oral mucositis', 'timeFrame': 'One treatment cycle (21days)', 'description': 'WHO Oral Mucositis Assessment Scale'}], 'secondaryOutcomes': [{'measure': 'Oral Condition Assessment', 'timeFrame': 'One treatment cycle (21days)', 'description': 'Oral Assessment Guide'}, {'measure': 'Salivary pH', 'timeFrame': 'One treatment cycle (21days)', 'description': 'Salivary pH was measured using pH test paper. Prior to testing, participants were required to fast (including no food or water) for one hour and to avoid activities that might alter salivary composition, such as using mouthwash, brushing teeth, smoking, or chewing gum. After one hour, a saliva sample was collected. Using a dropper, a sample was placed onto the pH test paper until it was fully saturated. After waiting for 10 seconds, the color change was compared against a standard color chart. Normal salivary pH typically falls within the range of 6.6 to 7.1, with a lower pH value indicating higher salivary acidity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Evidence-Based Nursing Protocol', 'Oral Mucositis'], 'conditions': ['Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy']}, 'referencesModule': {'references': [{'pmid': '41123400', 'type': 'RESULT', 'citation': 'Xu Y, Wang J, Zhang Y, Guo Z, Zhang W, Zhang S, Shi W, Ma W. Occurrence and Influencing Factors of Oral Mucositis in Patients With Cancer: A Cross-Sectional Study in China. Oncol Nurs Forum. 2025 Oct 20;52(6):460-472. doi: 10.1188/25.ONF.460-472.'}]}, 'descriptionModule': {'briefSummary': "Describe the incidence and influencing factors of cancer therapy-related oral mucositis. Based on evidence-based practice, develop a standardized nursing protocol for cancer therapy-related oral mucositis that aligns with China's national context and demonstrates strong clinical feasibility, and establish a clinical management pathway for cancer therapy-related oral mucositis. Validate the implementability of the standardized nursing protocol, and evaluate its clinical effectiveness and cost-effectiveness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a confirmed cancer diagnosis who are aware of their condition.\n* Patients currently undergoing non-surgical treatments such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy.\n* Patients who voluntarily agree to participate in this study and provide informed consent.\n\nExclusion Criteria:\n\n* Patients with autoimmune diseases;\n* Patients with primary or metastatic oral or lip cancer.;\n* Patients who are participating in other intervention studies.;\n* Swallowing problems existed in patients with Kubota drinking test \\> level 3;\n* Coma or inability to open mouth, difficulty cooperating with the researcher.'}, 'identificationModule': {'nctId': 'NCT07305766', 'briefTitle': 'Construction and Preliminary Application of Evidence-Based Nursing Protocol for Oral Mucositis Related to Tumor Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College'}, 'officialTitle': 'Construction and Preliminary Application of Evidence-Based Nursing Protocol for Oral Mucositis Related to Tumor Therapy', 'orgStudyIdInfo': {'id': 'No. PUMCSON-2023-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'In addition to providing patients with oral hygiene education (brushing teeth twice daily and rinsing with water after meals) and administering symptomatic treatment as prescribed, during their outpatient infusion visits, nurses will deliver evidence-based nursing interventions for cancer therapy-related oral mucositis through face-to-face education and guidance. Following discharge, patients will receive weekly online follow-up visits to enhance adherence to the protocol. Additionally, patients will be monitored for any adverse reactions or intolerance symptoms-such as nausea and vomiting-during the implementation of the evidence-based oral mucositis care regimen.', 'interventionNames': ['Behavioral: Conventional nursing measures']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'In addition to providing patients with oral hygiene education (brushing teeth twice daily and rinsing with water after meals) and administering symptomatic treatment as prescribed, during their outpatient infusion visits, nurses will deliver evidence-based nursing interventions for cancer therapy-related oral mucositis through face-to-face education and guidance. Following discharge, patients will receive weekly online follow-up visits to enhance adherence to the protocol. Additionally, patients will be monitored for any adverse reactions or intolerance symptoms-such as nausea and vomiting-during the implementation of the evidence-based oral mucositis care regimen.', 'interventionNames': ['Behavioral: Intervention group']}], 'interventions': [{'name': 'Intervention group', 'type': 'BEHAVIORAL', 'description': 'In addition to providing patients with oral hygiene education (brushing teeth twice daily and rinsing with water after meals) and administering symptomatic treatment as prescribed, during their outpatient infusion visits, nurses will deliver evidence-based nursing interventions for cancer therapy-related oral mucositis through face-to-face education and guidance. Following discharge, patients will receive weekly online follow-up visits to enhance adherence to the protocol. Additionally, patients will be monitored for any adverse reactions or intolerance symptoms-such as nausea and vomiting-during the implementation of the evidence-based oral mucositis care regimen.', 'armGroupLabels': ['Intervention group']}, {'name': 'Conventional nursing measures', 'type': 'BEHAVIORAL', 'otherNames': ['Control group'], 'description': 'Conventional nursing measures were provided, entailing patient education on oral care (brushing twice daily and rinsing with plain water postprandially), as well as symptom management according to established protocols.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100144', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Publication date: January 30, 2028', 'ipdSharing': 'YES', 'description': 'Published on ResMan (http://www.medresman.org.cn/)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master', 'investigatorFullName': 'Yutong XU', 'investigatorAffiliation': 'Peking Union Medical College'}}}}