Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-22 @ 8:55 AM
Study NCT ID:
NCT06542835
Status:
RECRUITING
Last Update Posted:
2024-10-23
First Post:
2024-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2024-07-19', 'studyFirstSubmitQcDate': '2024-08-02', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CRC Screening Completion at the Individual Level', 'timeFrame': '6 months', 'description': 'Measure the completion rate of colorectal cancer (CRC) screening at the individual level within 6 months of receiving the intervention. This will compare the proportion of participants in the post-intervention group versus the pre-intervention group.'}], 'secondaryOutcomes': [{'measure': 'FIT completion', 'timeFrame': '6 months', 'description': 'Measure the completion rate of fecal immunochemical tests (FIT) within 6 months of receiving the intervention. This will compare the proportion of participants who complete FIT in the post-intervention group versus the pre-intervention group.'}, {'measure': 'Rate of Follow-Up Colonoscopy Completion', 'timeFrame': '12 months', 'description': 'Track the completion rate of follow-up colonoscopy within 12 months for participants with abnormal FIT results, comparing the post-intervention versus pre-intervention groups.'}, {'measure': 'Time to follow-up colonoscopy', 'timeFrame': 'Within 12 months post abnormal FIT result', 'description': 'Measure the time from abnormal FIT result to the completion of follow-up colonoscopy, comparing the post-intervention versus the pre-intervention groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer screening', 'telehealth', 'video', 'text messaging', 'patient navigation', 'stool testing', 'fecal testing', 'Latinx health disparities'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '40526315', 'type': 'DERIVED', 'citation': 'Rivelli JS, Schneider JL, Vaughn KA, Locher BW, Shaw MC, Martinez LS, Ruiz E, Thompson JH, Escaron AL, Coronado GD. Improving animated instructional videos for colorectal cancer screening: An application of learner verification and revision. Transl Behav Med. 2025 Jan 16;15(1):ibaf020. doi: 10.1093/tbm/ibaf020.'}]}, 'descriptionModule': {'briefSummary': 'Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.', 'detailedDescription': 'The PRIME study aims to improve colorectal cancer (CRC) screening and follow-up among predominantly Latinx populations by using video text messages, mailed FIT kits, and patient navigation. The study will address multi-level barriers to screening, including misinformation, lack of access, and social determinants of health. The hypothesis is that a multi-component intervention will increase CRC screening rates and follow-up care, reducing disparities in CRC outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 45-64\n* Eligible for colorectal cancer (CRC) screening\n* Current patients (seen in the clinic in the last 6 months)\n* Primary speaker of English or Spanish\n* Cell phone listed in Electronic Health Record (EHR)\n* No recent history of CRC screening\n* Resides in one of the neighborhoods included in the main trial\n\nExclusion Criteria:\n\n* Colorectal disease (e.g., ulcerative colitis or colectomy)\n* Personal history of colorectal cancer\n* End-stage or life-threatening diseases\n* Known to be under hospice care\n* Living in a skilled nursing facility\n* Patients who decline research participation will be removed from the patient contact list'}, 'identificationModule': {'nctId': 'NCT06542835', 'acronym': 'PRIME', 'briefTitle': 'Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity', 'orgStudyIdInfo': {'id': 'STUDY00004612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video text message, mailed FIT, and social needs navigation', 'description': "Tailored video text message, mailed FIT, and navigation to address patients' social needs.", 'interventionNames': ['Behavioral: Video text message', 'Behavioral: Mailed FIT', 'Behavioral: Social needs navigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Colorectal cancer (CRC) screening offers during in-person clinic visits.', 'interventionNames': ['Behavioral: In-clinic CRC screening promotion', 'Behavioral: Reminders']}], 'interventions': [{'name': 'Video text message', 'type': 'BEHAVIORAL', 'description': 'Video text messages tailored to the Latinx population to educate and motivate patients to complete CRC screening.', 'armGroupLabels': ['Video text message, mailed FIT, and social needs navigation']}, {'name': 'In-clinic CRC screening promotion', 'type': 'BEHAVIORAL', 'description': 'Stool-test orders, colonoscopy referrals.', 'armGroupLabels': ['Usual care']}, {'name': 'Mailed FIT', 'type': 'BEHAVIORAL', 'description': 'Mailed FIT kits.', 'armGroupLabels': ['Video text message, mailed FIT, and social needs navigation']}, {'name': 'Social needs navigation', 'type': 'BEHAVIORAL', 'description': 'Patient navigation to address social needs.', 'armGroupLabels': ['Video text message, mailed FIT, and social needs navigation']}, {'name': 'Reminders', 'type': 'BEHAVIORAL', 'description': 'Centralized text and/or telephone reminders for ordered tests.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90040', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Escaron, PhD', 'role': 'CONTACT', 'email': 'aescaron@AltaMed.org', 'phone': '323-695-3601'}], 'facility': 'AltaMed Health Services Corporation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Gloria Coronado, PhD', 'role': 'CONTACT', 'email': 'gdcoronado@arizona.edu', 'phone': '5039147100'}, {'name': 'Katherine Mendoza, MPH', 'role': 'CONTACT', 'email': 'katherinemendoza@arizona.edu', 'phone': '8477672847'}], 'overallOfficials': [{'name': 'Anne Escaron, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AltaMed Health Services Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Diego State University', 'class': 'OTHER'}, {'name': 'AltaMed Health Services Corporation', 'class': 'OTHER'}, {'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gloria Coronado', 'investigatorAffiliation': 'University of Arizona'}}}}