Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-27 @ 12:19 PM
Study NCT ID:
NCT03398057
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2017-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: A Quasi-Experimental Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D016504', 'term': 'Breast Self-Examination'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D016353', 'term': 'Self-Examination'}]}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2017-12-28', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of health education on improving knowledge and practice regarding BC screening tools in health education group(75 female teachers) VS control group(75 female teachers)', 'timeFrame': 'Researchers assessed the improvement of participants knowledge and practice six weeks after applying of health education programs in both groups.', 'description': "Researchers assessed knowledge regarding BC detection and screening tools,through modified version of BCK test questionnaire which originally developed by Kathryn L.McCance,1989, USA, it contains nineteen questions. BSE knowledge and practices were assessed through BSE scale which developed by Champion,V.L.,1984, it contains fifteen questions.\n\nResearchers assessed clinical breast examination (CBE) and mammography practice through questions from ''Detection of Breast Cancer: Knowledge, Attitude, and Practice of Family Health Strategy Women'' questionnaire by de Oliveria RD and ''Intervention Tailoring for Chinese American Women: Comparing the Effect of Two Video on Knowledge, Attitudes, Intentions to Obtain a Mammogram'' questionnaire by Wang JH, it contains 4 questions.All previous questionnaires are valid and reliable instruments."}, {'measure': 'Effectiveness of health education on improving knowledge and practice regarding BC screening tools in health education group(75 female teachers) VS control group(75 female', 'timeFrame': 'Researchers assessed the improvement of participants knowledge and practice three months after applying of health education programs in both groups.', 'description': "Researchers assessed knowledge regarding BC detection and screening tools,through modified version of BCK test questionnaire which originally developed by Kathryn L.McCance,1989, USA, it contains nineteen questions. BSE knowledge and practices were assessed through BSE scale which developed by Champion,V.L.,1984, it contains fifteen questions.\n\nResearchers assessed clinical breast examination (CBE) and mammography practice through questions from ''Detection of Breast Cancer: Knowledge, Attitude, and Practice of Family Health Strategy Women'' questionnaire by de Oliveria RD and ''Intervention Tailoring for Chinese American Women: Comparing the Effect of Two Video on Knowledge, Attitudes, Intentions to Obtain a Mammogram'' questionnaire by Wang JH, it contains 4 questions.All previous questionnaires are valid and reliable instruments."}], 'secondaryOutcomes': [{'measure': 'Baseline knowledge and practice regarding BC screening tools in health education group(75 female teachers) VS control group(75 female teachers)', 'timeFrame': 'At the beginning of study, before applying of health education in both groups', 'description': "Researchers assessed knowledge regarding BC detection and screening tools,through modified version of BCK test questionnaire which originally developed by Kathryn L.McCance,1989, USA, it contains nineteen questions. BSE knowledge and practices were assessed through BSE scale which developed by Champion,V.L.,1984, it contains fifteen questions.\n\nResearchers assessed clinical breast examination (CBE) and mammography practice through questions from ''Detection of Breast Cancer: Knowledge, Attitude, and Practice of Family Health Strategy Women'' questionnaire by de Oliveria RD and ''Intervention Tailoring for Chinese American Women: Comparing the Effect of Two Video on Knowledge, Attitudes, Intentions to Obtain a Mammogram'' questionnaire by Wang JH, it contains 4 questions.All previous questionnaires are valid and reliable instruments."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer screening; health education; breast self-examination; clinical breast examination; mammography.'], 'conditions': ['Effect of Health Education Regarding Screening Tools of Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '29951902', 'type': 'DERIVED', 'citation': "Alameer A, Mahfouz MS, Alamir Y, Ali N, Darraj A. Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: a Quasi-Experimental Study. J Cancer Educ. 2019 Oct;34(5):865-870. doi: 10.1007/s13187-018-1386-9."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of health education in improving the knowledge and practices of female teachers regarding screening tools and the early detection of breast cancer.', 'detailedDescription': 'A two-group quasi-experimental design was conducted among 150 female teachers, who were selected from 75 schools of the Jazan General Administration of Education. Schools were chosen by a simple cluster randomization method. Schools were non-randomly assigned to either the intervention or control group. Eligible participants were recruited by a simple randomization method, proportional to the total number of teachers at each school. Those in the intervention group (n=75 teachers) were compared to the control group (n=75 teachers) at baseline, as well as at 6 weeks and 3 months post-intervention.\n\nStudy aim:\n\nAssess effectiveness of health education on improving knowledge and practices regarding Breast cancer(BC) early detection and screening tools among female teachers after six weeks, three months in health education group in compare with control group.\n\nSpecific objectives:\n\nEstimate level of awareness among female teachers regarding knowledge and practices of BC early detection and screening tools in Jazan area schools.\n\nMeasure the impact of health education on female teachers knowledge and practices regarding BC early detection and screening tools in health education group in compare with control group. So Research questions are:\n\nWhat is the current awareness level of female teachers in Jazan area schools regarding knowledge and practices of BC early detection and screening tools? Does health education improve knowledge and practices regarding BC early detection and screening tools among female teachers in Jazan area schools in health education group more than control group?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': '≥ 20 years. No personal history of BC. No first degree relative of BC. Not being pregnant or breast feeding. Ability to understand questionnaire', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 years. No personal history of BC. No first degree relative of BC. Not being pregnant or breast feeding. Ability to understand questionnaire\n\nExclusion Criteria:\n\nRefused to give informed consent. Sever medical problem prevent participation.'}, 'identificationModule': {'nctId': 'NCT03398057', 'briefTitle': "Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: A Quasi-Experimental Study", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Saudi Commission for Health Specialties, Saudi Arabia'}, 'officialTitle': "Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: A Quasi-Experimental Study", 'orgStudyIdInfo': {'id': 'AAAAlameer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health education group(intervention group)', 'description': 'Standardized heath education Program(SHEP) applied to this group participants .', 'interventionNames': ['Other: Health education']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo health education.', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Health education', 'type': 'OTHER', 'description': "SHEP included a comprehensive lecture about BC, with a generally deep focus on detection and screening tools, which were illustrated by a PowerPoint presentation with pictures and videos. The program also included a practical session about BSE (on breast silicon model). At the end of SHEP, a focused group discussion was conducted to answer participants' questions, and to discuss important barriers regarding BSE practice and visiting primary health care centers or clinics to undergo CBE and mammography. Different scientific and administrative solutions were discussed. SHEP materials were distributed as a hard copy (booklet) and in electronic format (CD) for all participants in the health education group at the end of training.", 'armGroupLabels': ['Health education group(intervention group)']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Placebo health education (pamphlets) will be applied to this group participants during study.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45911', 'city': 'Jizan', 'country': 'Saudi Arabia', 'facility': 'Jazan Area Schools', 'geoPoint': {'lat': 16.88917, 'lon': 42.55111}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'After analysis of data, we will destroy all individual data to save participants privacy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anwar Ali Ahmad Alameer', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'R4 physician in community medicine residency program in southern region. Principal investigator. Jazan Health Directorate, Ministry of Health, Jazan, Saudi Arabia', 'investigatorFullName': 'Anwar Ali Ahmad Alameer', 'investigatorAffiliation': 'Saudi Commission for Health Specialties, Saudi Arabia'}}}}