Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT05298605
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2022-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Faith in Action! A Church-Based Navigation Model to Increase Breast Cancer Screening in Korean Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in NIH PROMIS Global Health', 'timeFrame': 'Up to 6 months', 'description': 'Change in continuous NIH PROMIS converted T-Scores (mean 50, SD:10) at 6 months. Questionnaire includes physical and mental health domains (4 items total, likert 5-point scale, converted to continuous T scores)'}], 'primaryOutcomes': [{'measure': 'Screening adherence', 'timeFrame': 'up to 6 months from end of program', 'description': 'Percent change in adherence to breast cancer screening guidelines within 6 months from end of program'}], 'secondaryOutcomes': [{'measure': 'Breast Cancer Screening Beliefs (Knowledge, Perception, and perceived risk)', 'timeFrame': 'up to 6 months', 'description': 'Assessed in validated, Breast Cancer Screening Beliefs Questionnaire (Kwok et al) including Likert-type questions (13 items and 3 sub scales, items range 1-5, strongly agree to strongly disagree)'}, {'measure': 'Participant knowledge, attitudes, and beliefs towards screening (Qualitative)', 'timeFrame': 'up to 6 months', 'description': 'Assessed in qualitative interviews'}, {'measure': 'Change in Knowledge of Breast Cancer Screening', 'timeFrame': 'up to 6 months', 'description': 'Knowledge of breast cancer screening based on pre-post knowledge assessments adapted Cancer 101 assessments (3 knowledge assessments (5 items each), response categories: Agree, Disagree, or Unsure).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female', 'Health Knowledge, Attitudes, Practice', 'Cancer Screening', 'Health Disparities']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to develop a culturally adapted "Faith in Action!" curriculum to train lay health navigators to provide breast cancer screening navigation to Korean American women within faith-based settings and evaluate whether the culturally adapted "Faith in Action!" curriculum increases adherence to breast cancer screening guidelines among Korean American women within faith-based settings in Los Angeles, California. The primary research procedures include trainings and key informant interviews with lay health navigators in faith-based settings followed by a cluster randomized trial to evaluate the intervention.', 'detailedDescription': 'A parallel cluster randomized trial (CRT) with staggered roll-out will be conducted to evaluate the efficacy of the "Faith in Action!" intervention on breast cancer screening rates among Korean American women. This will involve two blocks of 8 churches each (total 16 churches) randomized to either the intervention or waitlist control.\n\nA train the trainer approach will be used to educate and certify lay health navigators identified by targeted Korean church leaders from selected churches. The trained health navigators will be deployed back to the churches and community settings with tools and resources to deliver cancer education and increase motivation to participate in breast cancer screening through proven approaches such as one-on-one education, small media and workshops.\n\nThe research objectives are to:\n\n1. Develop a culturally adapted "Faith in Action!" curriculum to train lay health navigators to provide breast cancer screening navigation to Korean American women within faith-based settings.\n2. Evaluate whether the culturally adapted "Faith in Action!" curriculum increases adherence to breast cancer screening guidelines among Korean American women within faith-based settings.\n\nIt is hypothesized that the implementation of this culturally adapted cancer screening training curriculum for lay health navigators, built upon the Korean communities\' frequent engagement with "expert" schools and deployed among existing networks in the faith-based Korean community, will increase adherence to breast cancer screening guidelines among underserved Korean American women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'Women at risk of breast cancer', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Korean woman who is 45 years or older\n* Does not currently have a breast cancer diagnosis\n* Non-adherent to cancer screening (did not receive mammogram in last 2 years based on self-report)\n* Prospective or current member of participating Korean Churches\n* Willing to participate in study\n\nExclusion Criteria:\n\n* Does not meet inclusion criteria as described above'}, 'identificationModule': {'nctId': 'NCT05298605', 'briefTitle': 'Faith in Action! A Church-Based Navigation Model to Increase Breast Cancer Screening in Korean Women', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Faith in Action! A Cluster-Randomized Trial to Evaluate the Efficacy of a Church-based Navigation Model to Increase Breast Cancer Screening Among Korean Women in Los Angeles', 'orgStudyIdInfo': {'id': 'STUDY00001641'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Faith in Action!', 'description': 'A train-the-trainer approach will be used to educate lay health navigators to present the culturally adapted "Faith in Action!" curriculum and to provide breast cancer screening navigation to Korean American women within faith-based settings', 'interventionNames': ['Behavioral: Faith in Action! Church-based Navigation Model']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'A presentation of lifestyle recommendations (e.g., physical activity, nutrition) will be provided to control groups.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Faith in Action! Church-based Navigation Model', 'type': 'BEHAVIORAL', 'description': 'Cancer screening education and navigation by identified trained navigators in faith based settings + American Cancer Society Screening Guidelines pamphlet', 'armGroupLabels': ['Faith in Action!']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Presentation on healthy behaviors (physical activity, nutrition) + American Cancer Society Screening Guidelines pamphlet', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Haile, DrPH', 'role': 'CONTACT'}, {'name': 'Gillian Gresham, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christie Jeon, ScD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allison Herrmann, PhD', 'role': 'CONTACT'}], 'facility': 'UCLA Kaiser Permanente Center for Health Equity', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Robert Haile, DrPH', 'role': 'CONTACT', 'email': 'Robert.haile@cshs.org', 'phone': '310-423-5167'}, {'name': 'Hayden Hutchison', 'role': 'CONTACT', 'email': 'Hayden.Hutchison@cshs.org', 'phone': '310-423-2361'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Within one year from end of study', 'ipdSharing': 'YES', 'description': 'Aggregated data at cluster level will be available upon reasonable request.', 'accessCriteria': 'Published protocol and uploaded to ClinicalTrials.Gov.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'California Breast Cancer Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Cancer Research Center for Health Equity, Professor, Department of Medicine, Associate Director for Population Health', 'investigatorFullName': 'Robert Haile', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}