Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT05834933
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2023-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nigerian Breast Cancer Risk-Reduction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018570', 'term': 'Risk Assessment'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D012306', 'term': 'Risk'}, {'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012308', 'term': 'Risk Management'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participants, Data collectors'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 719}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2023-03-05', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of BC risk assessment and counselling on adherence to breast screening recommendations among first-degree female relatives of BC patients in South-West Nigeria', 'timeFrame': '6 months', 'description': 'Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to breast screening practices'}, {'measure': 'Effects of BC risk assessment and counselling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of BC patients in South-West, Nigeria', 'timeFrame': '6 months', 'description': 'Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to lifestyle risk reduction practices'}, {'measure': 'Predictors of BSE among first-degree female relatives of BC patients in South-West Nigeria', 'timeFrame': '6 months', 'description': 'Statistical analysis will be carried out to determined the independent variables predicting BSE'}, {'measure': 'Predictors of time to first BC screening post-intervention among first-degree female relatives of BC patients in South-West Nigeria', 'timeFrame': 'Baseline', 'description': 'Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening'}], 'secondaryOutcomes': [{'measure': 'Determine the perception of familial BC risk among first-degree female relatives of BC patients in South-West Nigeria.', 'timeFrame': 'Baseline', 'description': 'Semi-structured questionnaires will be used to determine the perception of familial BC risk among participants'}, {'measure': 'Determine the knowledge of familiar BC risk among first-degree female relatives of BC patients in South-West Nigeria.', 'timeFrame': 'Baseline', 'description': 'Semi-structured questionnaires will be used to determine the knowledge of familiar BC risk among participants'}, {'measure': 'Determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among first-degree female relatives of BC patients in South-West Nigeria', 'timeFrame': 'Baseline', 'description': 'Semi-structured questionnaires will be used to determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among participants'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'First-degree relatives', 'Breast cancer prevention', 'Risk assessment', 'Risk counselling', 'Southwest Nigeria'], 'conditions': ['Risk Reduction Behavior', 'Breast Cancer', 'Health Behavior', 'Health Care Utilization', 'Health Knowledge, Attitudes, Practice']}, 'descriptionModule': {'briefSummary': "The study will be a randomized controlled trial. The aim of the study is to determine the Breast Cancer (BC) risk and to evaluate the effect of BC risk counseling on lifestyle changes and adherence to risk-reduction practices among first-degree female relatives of BC patients in South-West Nigeria. This study's research questions are:\n\n* What are the Nigeria Breast Cancer Study (NBCS) and Gail models estimates of the BC risk of first-degree female relatives of BC patients in South-West, Nigeria?\n* What are the effects of BC risk assessment and counseling on adherence to breast screening recommendations among first-degree female relatives of BC patients in South-West, Nigeria?\n* What are the effects of BC risk assessment and counseling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of BC patients in South-West, Nigeria?\n* What is the knowledge, attitudes, and perception of first-degree female relatives of BC patients in South-West Nigeria towards genetic testing and BC etiology?\n* What factors predict breast screening among first-degree female relatives of BC patients in South-West Nigeria?\n* What factors predict the time to first BC screening (post-intervention) among first-degree female relatives of BC patients in South-West Nigeria?\n\nParticipants will be randomized into the control arm (standard care) and intervention arms of the study. The intervention arm of the study will have a BC risk assessment followed by individualized BC risk counseling. In addition, the intervention arm will receive BC awareness and MammaCare® BSE training. The control arm will receive only standard care comprising BC awareness and MammaCare® BSE training. Both study arms will receive BC screening recommendations and lifestyle modification recommendations.\n\nWe hope that the BC risk counseling will improve BC screening practices and modification of risk behaviors and this hypothesis will be tested."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'For this study, first-degree female relatives are mothers, sisters, and daughters of BC patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. First-degree female relatives of histologically diagnosed BC patients in the study sites\n2. Women aged 20 to 75 years of age\n3. Willingness to be contacted after six months for follow-up\n\nExclusion Criteria:\n\n1. Personal history of BC\n2. Previous exposure to breast cancer risk assessment and counselling\n3. Absence of intact breasts'}, 'identificationModule': {'nctId': 'NCT05834933', 'acronym': 'NBCRS', 'briefTitle': 'Nigerian Breast Cancer Risk-Reduction Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Ibadan'}, 'officialTitle': 'Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria', 'orgStudyIdInfo': {'id': 'NHREC/05/01/2008a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard care (SC)', 'description': 'Participants received one-on-one breast cancer awareness education; one-on-one monthly Breast Self-Examination (BSE) training; general breast cancer screening recommendations; and general lifestyle modification recommendations'}, {'type': 'EXPERIMENTAL', 'label': 'SC + Risk assessment and counselling', 'description': 'Participants received Standard care as described in the SC arm above in addition to individualized breast cancer risk assessment, individualized breast cancer risk counseling, and lifestyle risk reduction recommendations', 'interventionNames': ['Behavioral: Individualized breast cancer risk assessment', 'Behavioral: Individualized breast cancer risk counselling']}], 'interventions': [{'name': 'Individualized breast cancer risk assessment', 'type': 'BEHAVIORAL', 'otherNames': ['Risk assessment'], 'description': 'Individualized breast cancer risk assessment: The Nigerian Breast Cancer Study (NBCS) absolute risk prediction model was used to predict the 5-year and lifetime breast cancer risks of the participants. The model utilized individual breast cancer risk factors.', 'armGroupLabels': ['SC + Risk assessment and counselling']}, {'name': 'Individualized breast cancer risk counselling', 'type': 'BEHAVIORAL', 'otherNames': ['Counseling'], 'description': 'Individualized breast cancer risk counselling: The Principal Investigator (PI) and other trained risk counsellors discussed the results of the NBCS risk prediction model with participants and counselled them about the risk of developing breast cancer. The', 'armGroupLabels': ['SC + Risk assessment and counselling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5538', 'city': 'Ile-Ife', 'state': 'Osun State', 'country': 'Nigeria', 'facility': 'Obafemi Awolowo University Teaching Hospital Complex (OAUTHC)', 'geoPoint': {'lat': 7.4824, 'lon': 4.56032}}, {'zip': '200285', 'city': 'Ibadan', 'state': 'Oyo State', 'country': 'Nigeria', 'facility': 'University College Hospital (UCH)', 'geoPoint': {'lat': 7.37756, 'lon': 3.90591}}, {'zip': '101233', 'city': 'Lagos', 'country': 'Nigeria', 'facility': 'Lagos State University Teaching Hospital (LASUTH)', 'geoPoint': {'lat': 6.45407, 'lon': 3.39467}}, {'zip': '102215', 'city': 'Lagos', 'country': 'Nigeria', 'facility': 'Lagos University Teaching Hospital (LUTH)', 'geoPoint': {'lat': 6.45407, 'lon': 3.39467}}], 'overallOfficials': [{'name': 'OLADOSUN A OJENGBEDE, FMCOG, FWACS, FICS, M.B.B.S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CENTER FOR POPULATION AND REPRODUCTIVE HEALTH (CPRH), UNIVERSITY COLLEGE HOSPITAL, IBADAN'}, {'name': 'OLADELE O.O KALE, B.A, M.B, B.Ch, B.A.O', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ibadan'}, {'name': 'IKEOLUWAPO O. AJAYI, MBBS; PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ibadan'}, {'name': 'CELIA IMARIA AGWAI, M.P.H; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ibadan'}, {'name': 'DEZHENG HUO, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Chicago'}, {'name': 'OLUFUNMILAYO OLOPADE, M.D., F.A.C.P', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ibadan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lagos State University Teaching Hospital (LASUTH)', 'class': 'UNKNOWN'}, {'name': 'Obafemi Awolowo University Teaching Hospital', 'class': 'OTHER'}, {'name': 'Lagos University Teaching Hospital (LUTH)', 'class': 'UNKNOWN'}, {'name': 'University College Hospital, Ibadan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Epidemiologist', 'investigatorFullName': 'Agwai Celia Imaria', 'investigatorAffiliation': 'University of Ibadan'}}}}