Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-24 @ 4:59 PM
Study NCT ID:
NCT06132295
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adoption of Multiple Strategies to Reduce the Rate of Marker Detachment During Radiotherapy in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009732', 'term': 'Nursing Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of times the surface marks disappeared or faded', 'timeFrame': 'The day the participants immediately after the radiotherapy.', 'description': 'The number of times the surface marks disappeared or faded during treatment was recorded on the day the participants immediately after the radiotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation Therapy', 'Cancer Patients', 'Tattooing']}, 'descriptionModule': {'briefSummary': "Investigators used in-house-designed radiotherapy red and green light markers to distinguish individual measures after the provision of the initial nursing care to participants, added a homemade health education leaflet to collect data via actual observation, and counted the disappearance or fading of participants' body markers", 'detailedDescription': "From January 1, 2023 to June 30, 2023, a total of 200 participants were enrolled and undergoing radiation therapy. Inclusion Criteria: clear consciousness who could understand and comprehend Mandarin Chinese. Exclusion Criteria: patients with impaired consciousness or decreased cognitive abilities.\n\nInvestigators proposed a set of strategic initiatives :\n\n1. Consistent Schedule for the Replacement of Positioning Line Pens: Consistent Schedule for the Replacement of Positioning Line Pens: Investigators recommend implementing a standardized replacement schedule for positioning line pens, with replacement performed after every 50 uses.\n2. Tailored Educational Content: Investigators created personalized educational content tailored to each patient's educational background. This approach ensures that participants can easily understand their treatment plan.\n3. Hypoallergenic Adhesive Patches: Investigators offered a variety of hypoallergenic adhesive patches, catering to the skin characteristics of individual participants.\n4. Enriched Treatment Care Platform: Investigators commitment extended to creating a comprehensive treatment care platform, which provided guidance on positioning line usage, interactive community features, and practical information.\n5. Participants with BMI \\> 25 and an education level of high school or below, without specific caregivers, were identified by placing a red dot on the treatment record and on the patient's happiness card. Patients with BMI \\< 25 and an education level of high school or above, with specific caregivers, were identified by placing a green dot on their records.\n6. After implementing the red-green light differentiation for radiation therapy and individual interventions, educational pamphlets prepared in-house were added, to assess the maintenance status of the positioning marks.\n\nThe number of times the surface marks disappeared or faded during treatment was recorded on the day the participants completed treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants with clear consciousness.\n* participants could understand and comprehend Mandarin Chinese.\n\nExclusion Criteria:\n\n* participants with impaired consciousness or decreased cognitive abilities.'}, 'identificationModule': {'nctId': 'NCT06132295', 'briefTitle': 'Adoption of Multiple Strategies to Reduce the Rate of Marker Detachment During Radiotherapy in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Adoption of Multiple Strategies to Reduce the Rate of Marker Detachment During Radiotherapy in Patients With Cancer', 'orgStudyIdInfo': {'id': '2023-A-037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nursing care', 'description': "Investigators used in-house-designed radiotherapy red and green light markers to distinguish individual measures after the provision of the initial nursing care to participants, added a homemade health education leaflet to collect data via actual observation, and counted the disappearance or fading of participants' body markers", 'interventionNames': ['Other: Nursing care']}], 'interventions': [{'name': 'Nursing care', 'type': 'OTHER', 'description': "1. Consistent Schedule for the Replacement of Positioning Line Pens\n2. Tailored Educational Content\n3. Hypoallergenic Adhesive Patches\n4. Enriched Treatment Care Platform\n5. Participants with BMI \\> 25 and an education level of high school or below, without specific caregivers, were identified by placing a red dot on the treatment record and on the patient's happiness card. Patients with BMI \\< 25 and an education level of high school or above, with specific caregivers, were identified by placing a green dot on their records.\n6. Individual interventions, educational pamphlets prepared in-house were added, to assess the maintenance status of the positioning marks.", 'armGroupLabels': ['Nursing care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '408025', 'city': 'Taichung', 'state': 'Taiwan (r.o.c.)', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}