Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT06362993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Breast Cancer Screening in Ghana
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical breast exam (CBE) utilization at the local clinic', 'timeFrame': '6 months. Outcome is measured at endline survey at the end of the 6-month period.', 'description': 'The outcome will be measured by asking participants, at endline, if they sought clinical breast exam at their local clinic during the 6-month study period. This information will be verified at the clinic level using Participation Cards, which will be provided to participants at the beginning of the 6-month period. Participants will be asked to bring the Card to the clinic when they come for screening.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': "This study is designed to test the feasibility of two intervention on promoting early screening for breast cancer in rural Ghana. In one intervention, screening for breast cancer, diabetes and hypertension will be offered together. In another intervention, a series of sessions with men will be conducted with a goal to change gender attitudes and increase support to women. The investigators' long-term goal is to test these interventions in a large-scale randomized controlled trial. The specific aims of this feasibility study are to: 1) refine the study materials, including the curriculum for the sessions with men, by consulting with an expert advisory committee and a local committee, and 2) determine the feasibility of the two interventions in four clinic zones in Yilo-Krobo district in eastern Ghana (1 clinic in control, 1 clinic in the first intervention, and 2 in the second intervention). This trial registration is for the second specific aim."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥20 years. The age cutoff reflects early onset of BC in Ghana and the government's guidelines on screening.\n\nExclusion Criteria:\n\n* ever clinically diagnosed with a case of breast cancer, as the study's aim is to reach women who would normally not visit or have experience with the health system with regard to breast cancer.\n\nNOTE: For men in the MEGH arm, Inclusion and Exclusion Criteria are:\n\nInclusion Criteria: aged ≥20 years who are identified as male partners or relatives by the women enrolled in the MEGH group.\n\nExclusion Criteria: none."}, 'identificationModule': {'nctId': 'NCT06362993', 'briefTitle': 'Breast Cancer Screening in Ghana', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Testing Approaches to Promote Breast Cancer Screening in Rural Ghana', 'orgStudyIdInfo': {'id': 'STUDY00021561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Women in this arm receive education on breast cancer and are offered clinical breast exam free of charge at their local clinic for 6 months following the education session.'}, {'type': 'EXPERIMENTAL', 'label': 'Bundling', 'description': 'Women in this arm receive education on breast cancer, diabetes, and hypertension, and are offered clinical breast exam and screening for diabetes and hypertension free of charge at their local clinic for 6 months following the education session.', 'interventionNames': ['Other: Bundling']}, {'type': 'EXPERIMENTAL', 'label': 'Male Engagement in Gender and Health (MEGH)', 'description': "Women in this arm receive education on breast cancer and are offered clinical breast exam free of charge at their local clinic for 6 months following the education session. In addition, women are requested to invite their male partners to attend the breast cancer education session and 7 weekly discussion group sessions (5 men-only and 2 with women). The discussion sessions aim to enable men to change gender attitudes and behaviors that deter women's healthcare utilization.", 'interventionNames': ['Other: MEGH']}], 'interventions': [{'name': 'Bundling', 'type': 'OTHER', 'description': 'Education on and screening for diabetes and hypertension offered together with education and screening for breast cancer.', 'armGroupLabels': ['Bundling']}, {'name': 'MEGH', 'type': 'OTHER', 'description': "Education on breast cancer and discussion sessions to male partners to change men's gender attitudes and behaviors.", 'armGroupLabels': ['Male Engagement in Gender and Health (MEGH)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Accra', 'country': 'Ghana', 'facility': 'University of Ghana', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}], 'overallOfficials': [{'name': 'Nancy Luke, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'The Pennsylvania State University'}, {'name': 'Adriana Biney, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Ghana, Regional Institute for Population Studies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ghana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yubraj Acharya, Ph.D.', 'investigatorAffiliation': 'Penn State University'}}}}