Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-23 @ 4:55 PM
Study NCT ID:
NCT03078361
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2017-03-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020794', 'term': 'Receptor Protein-Tyrosine Kinases'}], 'ancestors': [{'id': 'D011505', 'term': 'Protein-Tyrosine Kinases'}, {'id': 'D011494', 'term': 'Protein Kinases'}, {'id': 'D017853', 'term': 'Phosphotransferases (Alcohol Group Acceptor)'}, {'id': 'D010770', 'term': 'Phosphotransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After completion of baseline assessments, participants will be randomized so that the study personnel are unaware of the intervention assignment at the time of the baseline assessment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2017-03-03', 'studyFirstSubmitQcDate': '2017-03-07', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Feedback from Community Advisory Board', 'timeFrame': 'Up to 4 months', 'description': 'Successful collection of feedback to complete production of Spanish-language LATINOS CARES Intervention.\n\nThis aim involves no statistical analysis except the summary statistics for the participants. To adapt (transcreate) and produce an educational intervention entitled LATINOS CARES (DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population. BENCHMARK: Production of Spanish-language LATINOS CARES intervention that is easy-to understand, salient, and culturally suitable.'}], 'secondaryOutcomes': [{'measure': 'Rate of Receipt of I-FOBT from Participants', 'timeFrame': 'Up to 4 months', 'description': 'BENCHMARK: Receipt of Immunochemical Fecal Occult Blood Test (I-FOBT home kit).'}, {'measure': 'Rate of Receipt of Assessments from Participants', 'timeFrame': 'Up to 4 months', 'description': 'BENCHMARK: Receipt of Assessments.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer screening', 'colon'], 'conditions': ['Colorectal Cancer', 'Colorectal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '35238785', 'type': 'DERIVED', 'citation': 'Chavarria EA, Christy SM, Feng H, Miao H, Abdulla R, Gutierrez L, Lopez D, Sanchez J, Gwede CK, Meade CD. Online Health Information Seeking and eHealth Literacy Among Spanish Language-Dominant Latino Adults Receiving Care in a Community Clinic: Secondary Analysis of Pilot Randomized Controlled Trial Data. JMIR Form Res. 2022 Oct 13;6(10):e37687. doi: 10.2196/37687.'}, {'pmid': '33990120', 'type': 'DERIVED', 'citation': 'Christy SM, Cousin LA, Sutton SK, Chavarria EA, Abdulla R, Gutierrez L, Sanchez J, Lopez D, Gwede CK, Meade CD. Characterizing Health Literacy Among Spanish Language-Preferring Latinos Ages 50-75. Nurs Res. 2021 Set/Oct 01;70(5):344-353. doi: 10.1097/NNR.0000000000000519.'}], 'seeAlsoLinks': [{'url': 'https://moffitt.org/', 'label': 'Moffitt Cancer Center Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to conduct 4 focus groups and recruit for 12 participants per focus group to explore community members' views about colorectal cancer screening (CRCS) processes and perceived benefits and impediments, what information they believe should be communicated, communication preferences (style, tone) and perceptions of screenings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, age 50-75 years\n* Self-identify as Hispanic/Latino\n* Able to understand, read, and speak Spanish\n* Prefer to receive health information in Spanish\n* Previously screened or not screened'}, 'identificationModule': {'nctId': 'NCT03078361', 'briefTitle': 'Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening) Project', 'orgStudyIdInfo': {'id': 'MCC-17665'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LATINOS CARES Toolkit', 'description': 'Participants assigned to the LATINOS CARES condition will receive an I-FOBT kit, DVD and photonovella booklet from the study coordinator. The participant will view the DVD in a private area (headphones are available) using a portable DVD player in clinic before seeing the provider. The DVD will be about 8-10 minutes long. The participant will take the LATINOS CARES toolkit and I-FOBT home after the clinic visit. The participant will be instructed to re-review the materials and complete the I-FOBT stool sampling at home.', 'interventionNames': ['Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit', 'Behavioral: LATINOS CARES Toolkit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Intervention (SI)', 'description': 'Participants assigned to the standard brochure (SI) will be provided a packet containing the CDC Spanish-language tri-fold brochure titled Screen for Life and an I-FOBT card. The participant will be instructed to review the materials in clinic and complete the I-FOBT stool sampling at home. This brochure describes CRC, risk factors, symptoms, screening tests, benefits of screening, and insurance coverage.', 'interventionNames': ['Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit', 'Behavioral: Standard Intervention']}], 'interventions': [{'name': 'Immunochemical Fecal Occult Blood Test (I-FOBT) Kit', 'type': 'OTHER', 'description': 'Both intervention groups will receive an I-FOBT kit (by study coordinator) with verbal and written instructions in Spanish on how to complete the stool sampling at home within 1 week, and mail the completed kit in the pre-addressed, postage paid mailer. Patients with abnormal results will receive a call explaining the meaning of an abnormal I-FOBT and encouraging them to take specific next steps.', 'armGroupLabels': ['LATINOS CARES Toolkit', 'Standard Intervention (SI)']}, {'name': 'LATINOS CARES Toolkit', 'type': 'BEHAVIORAL', 'description': 'DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population.', 'armGroupLabels': ['LATINOS CARES Toolkit']}, {'name': 'Standard Intervention', 'type': 'BEHAVIORAL', 'description': 'Standard intervention (CDC brochure) on colorectal cancer screening in community health clinics.', 'armGroupLabels': ['Standard Intervention (SI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Clement Gwede, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Lee Moffitt Cancer Center and Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida Department of Health', 'class': 'OTHER_GOV'}, {'name': 'Bankhead-Coley Cancer Research Program', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}