Nctid:
NCT06233383
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001943", "term"=>"Breast Neoplasms"}], "ancestors"=>[{"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000001941", "term"=>"Breast Diseases"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "asFound"=>"Breast Cancer", "relevance"=>"HIGH"}, {"id"=>"M5218", "name"=>"Breast Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-06-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2025-06-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-07-22", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-23", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-06-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Implementation Strategies Suite", "timeFrame"=>"2 years", "description"=>"A collection of strategies for implementing routine screening clinical breast examination in Soweto's primary care clinics."}], "secondaryOutcomes"=>[{"measure"=>"Intervention Domain Characteristics", "timeFrame"=>"2 years", "description"=>"Characteristics of routine clinical breast examination itself that are potential barriers and facilitators to screening implementation"}, {"measure"=>"Inner Setting Domain Characteristics", "timeFrame"=>"2 years", "description"=>"Characteristics of the primary care clinics that are potential barriers and facilitators to screening implementation"}, {"measure"=>"Outer Setting Domain Characteristics", "timeFrame"=>"2 years", "description"=>"Characteristics of both the community surrounding the clinics and the district-wide health system that are potential barriers and facilitators to screening implementation"}, {"measure"=>"Individuals Domain Characteristics", "timeFrame"=>"2 years", "description"=>"Characteristics of individuals involved in screening that are potential barriers and facilitators to screening implementation"}, {"measure"=>"Implementation Domain Characteristics", "timeFrame"=>"2 years", "description"=>"Characteristics of activities and strategies used to implement screening that are potential barriers and facilitators to screening implementation"}, {"measure"=>"Change Matrices", "timeFrame"=>"2 years", "description"=>"Matrices for all individuals relevant to implementation that define performance objectives and corresponding performance determinants"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Breast Cancer"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to engage with multilevel stakeholders to collaboratively and to systematically develop a suite of strategies for implementing breast cancer screening using clinical breast examination (CBE) in the primary health centers within the catchment area of Chris Hani Baragwanath Academic Hospital (Bara Hospital), Johannesburg, South Africa.\n\nThe main questions it aims to answer are: What barriers and facilitators exist to conducting screening CBE in Soweto's primary care setting and what implementation strategies would support CBE in primary care clinics?\n\nParticipants will:\n\n* Allow observation of study clinic workflows\n* Participate in focus group discussions regarding screening CBE implementation"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Focus group participants will consist of three categories: screening CBE \"adopter\" (e.g., clinic administrators/managers, department of health officials, etc), \"implementers\" (e.g., nurses, physicians, community health workers), and \"recipients\" (e.g., women from the community eligible for CBE screening and community breast cancer survivors).\n\nAll participants will be drawn from the four study clinics in Soweto, South Africa.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"In order to be eligible for inclusion in the focus group discussions held with screening CBE \"adopters\" and \"implementers,\" an individual must meet all of the following criteria:\n\n1. Be an employee or volunteer working at a participating PHC OR Be an employee or volunteer working at South Africa's National Department of Health OR Be an employee or volunteer working with a non-governmental organization that performs breast cancer related activities within the catchment area of a participating PHC\n2. Be willing to commit to keeping the content of focus group discussions confidential\n\nIn order to be eligible for inclusion in the focus group discussions held with screening CBE \"recipients,\" an individual must meet all of the following criteria:\n\n1. Be female\n2. Be between the ages of 40 and 65 years\n3. Be living within the catchment area of a participating PHC\n4. Be willing to commit to keeping the content of focus group discussions confidential"}, "identificationModule"=>{"nctId"=>"NCT06233383", "briefTitle"=>"Developing Screening Clinical Breast Examination Implementation Strategies in South Africa", "organization"=>{"class"=>"OTHER", "fullName"=>"Yale University"}, "officialTitle"=>"Developing an Approach to Implementing Breast Cancer Screening Using Clinical Breast Exam in the Primary Health Centers of Soweto, South Africa", "orgStudyIdInfo"=>{"id"=>"2000036834"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Adopters", "description"=>"Individuals responsible for deciding to institute screening CBE in Soweto's primary care clinics (e.g., policymakers, clinic administrators, nurse managers)"}, {"label"=>"Implementers", "description"=>"Individuals responsible for actually performing the screening CBE in Soweto's primary care clinics (e.g., nurses, doctors, fieldworkers, clerical workers)"}, {"label"=>"Recipients", "description"=>"Individuals eligible for a screening CBE (e.g., women over the age of 40 years from the community surrounding study clinics)"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Johannesburg", "status"=>"RECRUITING", "country"=>"South Africa", "contacts"=>[{"name"=>"Maureen Joffe", "role"=>"CONTACT"}], "facility"=>"University of Witwatersrand, Faculty of Health Sciences", "geoPoint"=>{"lat"=>-26.20227, "lon"=>28.04363}}], "centralContacts"=>[{"name"=>"Daniel O'Neil, MD, MPH", "role"=>"CONTACT", "email"=>"daniel.oneil@yale.edu", "phone"=>"347-414-0560"}], "overallOfficials"=>[{"name"=>"Daniel O'Neil, MD, MPH", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Yale School of Medicine"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"In order to comply with local legal requirements, individual participant data will not be available to other researchers."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yale University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"University of Witwatersrand, South Africa", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
