Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-30 @ 5:21 AM
Study NCT ID:
NCT06386861
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-05
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057285', 'term': 'Precision Medicine'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '500 English-speaking individuals identifying as Hispanic, Latino, or Latina 500 Spanish-speaking individuals identifying as Hispanic, Latino, or Latina'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 851}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-24', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychometric properties', 'timeFrame': 'up to two weeks', 'description': 'Establish the psychometric properties of the translated AGPM'}], 'secondaryOutcomes': [{'measure': 'Health literacy/numeracy', 'timeFrame': 'up to two weeks', 'description': 'Establish correlations between health literacy/numeracy and AGPM scores'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genomics', 'precision medicine', 'attitudes and beliefs', 'health literacy', 'health numeracy'], 'conditions': ['Adult ALL']}, 'referencesModule': {'references': [{'pmid': '34267947', 'type': 'BACKGROUND', 'citation': 'DuBois JM, Mozersky J, Antes A, English T, Parsons MV, Baldwin K. Attitudes toward genomics and precision medicine. J Clin Transl Sci. 2021 Apr 8;5(1):e120. doi: 10.1017/cts.2021.774. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino, or Latina. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population.', 'detailedDescription': 'The investigators will recruit 1,000 individuals (500 English-speaking and 500 Spanish-speaking) to complete the AGPM and previously validated instruments assessing health literacy and numeracy. Results will establish the psychometric properties of the Spanish version of the AGPM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult (18+ yrs.)\n* identifying as Hispanic, Latino, or Latina\n* able to provide opt-in electronic informed consent\n\nExclusion Criteria:\n\n* under age 18 yrs.\n* not identifying as Hispanic, Latino, or Latina\n* not able to provide opt-in electronic informed consent'}, 'identificationModule': {'nctId': 'NCT06386861', 'briefTitle': 'Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM).', 'organization': {'class': 'OTHER', 'fullName': 'Boston College'}, 'officialTitle': 'Developing Culturally-Tailored Interventions to Overcome Genomic Health Disparities in Communities of Color', 'orgStudyIdInfo': {'id': '24.210.01e'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'AGPM for English Speakers', 'description': 'Participants identifying as Hispanic, Latino, or Latina whose primary language is English', 'interventionNames': ['Other: Attitudes Toward Genomics and Precision Medicine (English)']}, {'type': 'OTHER', 'label': 'AGPM for Spanish Speakers', 'description': 'Participants identifying as Hispanic, Latino, or Latina whose primary language is Spanish', 'interventionNames': ['Other: Attitudes Toward Genomics and Precision Medicine (Spanish)']}], 'interventions': [{'name': 'Attitudes Toward Genomics and Precision Medicine (English)', 'type': 'OTHER', 'description': 'completing the English version of the AGPM and validated health literacy and numeracy instruments', 'armGroupLabels': ['AGPM for English Speakers']}, {'name': 'Attitudes Toward Genomics and Precision Medicine (Spanish)', 'type': 'OTHER', 'description': 'completing the Spanish version of the AGPM and validated health literacy and numeracy instruments', 'armGroupLabels': ['AGPM for Spanish Speakers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston College', 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}], 'overallOfficials': [{'name': 'Andrew A Dwyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston College'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'timeFrame': 'Following publication, available indefinitely through the developers of the AGPM', 'ipdSharing': 'YES', 'description': 'De-identified data will be shared with the developers of the AGPM', 'accessCriteria': 'Must contact the AGPM developers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}