Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-30 @ 5:55 AM
Study NCT ID:
NCT06365450
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast and Cervical Cancer Education Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each participant is required to attend (in person or virtually via Zoom) two educational sessions one on breast cancer and the other on cervical cancer.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-10', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool.', 'timeFrame': 'Immediately Post intervention', 'description': 'The dimensions of health literacy adapted from the AHL-C tool are:\n\n1. Numeracy (2 items)\n2. Familiarity (9 items)\n3. Comprehension (1 item)\n4. Navigation (7 items).\n\nTo determine health literacy scores of participants, each item will be scored on a scale of 0 to 1. A higher score would mean a better outcome. Items will be summed for each of the four sub-scales as well as the entire scale (AHL-C) and then determine the mean and standard deviation.\n\nAssessment will be completed immediately post intervention (after two sessions on breast and cervical cancer)'}], 'secondaryOutcomes': [{'measure': 'Number of participants recruited from each community partner', 'timeFrame': 'Immediately Post intervention', 'description': 'Participants recruited from each community partner'}, {'measure': 'Number of participants who preferred virtual or in person sessions', 'timeFrame': 'Immediately Post intervention', 'description': 'Participant session attendance preference'}, {'measure': 'Number of participants who were lost of follow up', 'timeFrame': 'Immediately post intervention', 'description': 'Participants lost to follow up'}, {'measure': 'Number of participants who needed help redeeming their gift codes', 'timeFrame': 'Immediately post intervention', 'description': 'Participants needing help redeeming gift cards'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Breast Cancer', 'Health Behavior']}, 'descriptionModule': {'briefSummary': "The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference.", 'detailedDescription': "The aims of this study are to:\n\n1. develop educational materials on breast and cervical cancer screening;\n2. administer the intervention using a PowerPoint presentation;\n3. evaluate changes in breast and cervical cancer literacy levels after the intervention; and\n4. assess participants'; satisfaction with the program"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to read and write in English\n* self-identify as HIV positive -\n* Black/African American.\n\nExclusion Criteria:\n\n* Acutely ill'}, 'identificationModule': {'nctId': 'NCT06365450', 'acronym': 'OCEAP', 'briefTitle': 'Breast and Cervical Cancer Education Program', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'OWEL Cancer Education and Awareness Program (OCEAP)', 'orgStudyIdInfo': {'id': 'IRB00315481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Single-group', 'description': '1 educational session on cervical cancer and one educational session on breast cancer', 'interventionNames': ['Other: Educational Intervention']}], 'interventions': [{'name': 'Educational Intervention', 'type': 'OTHER', 'description': 'Participants will receive hybrid educational intervention on breast and cervical cancer', 'armGroupLabels': ['Educational Single-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Nursing', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Hae-Ra Han, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Older Women Embracing Life', 'class': 'UNKNOWN'}, {'name': 'The John G. Bartlett Specialty Practice', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}