Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-05 @ 5:34 PM
Study NCT ID:
NCT06791603
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2025-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Social Media-delivered Chemotherapy Side Effects Education for Breast Cancer Patients Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2025-01-11', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A questionnaire with 5 questions of side effects management', 'timeFrame': '1. First time receiving chemotherapy 2. Second time receiving chemotherapy (3 to 4 weeks depend on schedule)', 'description': 'Each question is a multiple choice with 4 options and 1 correct answer'}], 'secondaryOutcomes': [{'measure': 'FACT-B, The Functional Assessment of Cancer Therapy - Breast', 'timeFrame': '1. First time receiving chemotherapy 2. Second time receiving chemotherapy (3 to 4 weeks depend on schedule)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pharmacist', 'chemotherapy education', 'social media'], 'conditions': ['Chemotherapy Side Effects', 'Social Media', 'Education of Patients']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if a standardized pharmacists-provided education module by social media can improve patients' knowledge of chemotherapy-related side effects. The main questions it aims to answer is:\n\n• Do patients who received a standardized pharmacists-provided education module by social media improve their knowledge of chemotherapy-related side effects? Researchers will compare standardized chemotherapy education +video (experimental group) versus chemotherapy handouts (control group).\n\nParticipants will:\n\n* Received standardized chemotherapy education + video or chemotherapy handouts at the first and second chemotherapy section.\n* Fill out a questionnaire for outcomes assessment.", 'detailedDescription': 'The pharmacist-provided video education model for patients undergoing first time chemotherapy was developed. The content of the education video included the mechanism of side effects, its recognition, preventive measures, non-medical management, and further instructions when to visit hospital were included.\n\nPatients were randomly assigned into two groups with different education strategies:\n\nStandardized chemotherapy education +video (experimental group) versus chemotherapy handouts (control group). Every patient was asked to fill out a questionnaire prior to the implementation of the education model in both groups. The pre-test questionnaires consisted of baseline knowledge and personal information. Patients in the experimental group would receive standardized chemotherapy education by pharmacists, including chemotherapy regimen, the purpose of chemotherapy, the number of cycles, duration of chemotherapy and the common side effects of chemotherapy on the first day of chemotherapy cycle. Videos will be provided with patients and they will watch videos during the visit. The information regarding the prevention and management of side effects and further instructions when to visit hospital. Patients will have access to videos and watch videos after leaving the hospital for the entire treatment course. The education time will be last around 15 to 20 minutes. In terms of control group, pharmacists will briefly explain and provide chemotherapy handouts, including chemotherapy regimen, the purpose of chemotherapy, the number of cycles, duration of chemotherapy and the common side effects of chemotherapy. The duration of visit will be around 5 to 10 minutes. After the education section, patients will be asked to do a post-test questionnaire of their knowledge and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer patients aged 18 or older undergoing their first chemotherapy.\n* Possess a smartphone and are able to watch videos on it.\n\nExclusion Criteria:\n\n* Unable to read or complete questionnaires in Chinese.\n* Cognitive impairments.\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT06791603', 'briefTitle': 'The Impact of Social Media-delivered Chemotherapy Side Effects Education for Breast Cancer Patients Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Shuang Ho Hospital'}, 'officialTitle': 'The Impact of Social Media-delivered Chemotherapy-related Side Effects Education for Breast Cancer Patients Receiving First Time Chemotherapy', 'orgStudyIdInfo': {'id': 'TMU-JIRB N202410024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standardized chemotherapy education + video', 'description': 'Standardized chemotherapy education+ video', 'interventionNames': ['Other: Standardized chemotherapy education + video']}, {'type': 'NO_INTERVENTION', 'label': 'Chemotherapy handouts', 'description': 'Chemotherapy handouts'}], 'interventions': [{'name': 'Standardized chemotherapy education + video', 'type': 'OTHER', 'description': 'Videos will be provided with patients and they will watch videos during the visit. The information regarding the prevention and management of side effects and further instructions when to visit hospital. Patients will have access to videos and watch videos after leaving the hospital for the entire treatment course', 'armGroupLabels': ['Standardized chemotherapy education + video']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Pohung Lin', 'role': 'CONTACT', 'email': '19365@s.tmu.edu.tw', 'phone': '02-2249-0088 #1168'}], 'facility': 'Shuang Ho Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Pohung Lin, PharmD', 'role': 'CONTACT', 'email': '19365@s.tmu.edu.tw', 'phone': '886-933-826-267'}], 'overallOfficials': [{'name': 'Pohung Lin, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University Shuang Ho Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Shuang Ho Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, clinical pharmacist', 'investigatorFullName': 'Pohung Lin', 'investigatorAffiliation': 'Taipei Medical University Shuang Ho Hospital'}}}}