Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT06052202
Status:
COMPLETED
Last Update Posted:
2025-05-13
First Post:
2023-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-03', 'releaseDate': '2025-11-21'}, {'releaseDate': '2025-12-11'}], 'estimatedResultsFirstSubmitDate': '2025-11-21'}}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-09-18', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Receipt of Colorectal Cancer Screening Test at Month 6', 'timeFrame': 'Month 6', 'description': 'Whether or not a participant received a colorectal cancer screening test since beginning the study. The date and type of screening will be verified via electronic medical records. A value of "0" will be recorded if no screening test is found in the electronic health record. A value of "1" will be recorded if a screening test is found in the electronic health record.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Perceived Severity of Colorectal Cancer at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': "Measured using the 12-item perceived severity subscale of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. Items are averaged to form a score ranging from 0 to 4 with higher scores indicating higher perceived severity."}, {'measure': 'Change from Baseline in Perceived Susceptibility to Colorectal Cancer at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': "Measured using the 5-item perceived susceptibility subscale of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. Items are averaged to form a score ranging from 0 to 4 with higher scores indicating higher perceived susceptibility."}, {'measure': 'Change from Baseline in Perceived Benefits to Colonoscopy at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': "Measured using Rawl and colleagues' (2001) 5-item perceived benefits to colonoscopy scale. Items are averaged to form a score ranging from 0 to 4 with higher scores indicating higher perceived benefits to colonoscopy."}, {'measure': 'Change from Baseline in Perceived Benefits to Stool Test at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': "Measured using Rawl and colleagues' (2001) 5-item perceived benefits to fecal occult blood test scale. Items are averaged to form a score ranging from 0 to 4 with higher scores indicating higher perceived benefits to stool tests."}, {'measure': 'Change from Baseline in Cancer Fatalism at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Measured using the 15-item Powe Fatalism Inventory. Items are averaged to form a score ranging from 0 to 4 with higher scores indicating higher cancer fatalism beliefs.'}, {'measure': 'Change from Baseline in Colorectal Cancer Knowledge at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': "Measured using the 16-item CRC Knowledge test subsection of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. The true/false items are scored 1 (correct) or 0 (incorrect) and summed to form a score ranging from 0 to 16. Higher scores indicate greater colorectal cancer knowledge."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test a new smartphone-based program designed to help African American men get screened for colorectal cancer (CRC). The main question it aims to answer is:\n\n° Are African American men who complete the smartphone-based program more likely to get screened for colorectal cancer than men who do not?\n\nParticipants will:\n\n* Complete a baseline survey asking about their colorectal cancer screening history and their thoughts and beliefs about colorectal cancer and the medical system.\n* Be randomized to receive the new smartphone-based program or to receive text messages containing colorectal cancer education materials designed by the Centers for Disease Control (CDC). The new program sends text messages with information about colorectal cancer. Some of these text messages have links to videos that try to help men overcome anything that may stand in the way of getting screened.\n* Complete a follow-up survey 6 months after the baseline survey. This survey will ask the same questions as the baseline survey.\n* A medical records review will be conducted at 6 months to verify whether participants received a colorectal cancer screening test during the study period.\n\nResearchers will compare participants who receive the new smartphone-based program to participants who receive the CDC information. The goal is to see whether the smartphone-based program increasing screening more than standard educational materials available on the internet.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American/Black\n* not compliant with current United States Preventive Services Taskforce colorectal cancer screening recommendations\n* owns a mobile phone capable of text messaging and accessing webpages\n* able to speak/understand English\n\nExclusion Criteria:\n\n* personal history of colorectal cancer'}, 'identificationModule': {'nctId': 'NCT06052202', 'briefTitle': 'A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men', 'organization': {'class': 'OTHER', 'fullName': 'ISA Associates, Inc.'}, 'officialTitle': 'Reducing Colorectal Cancer Health Disparities: An mHealth Intervention to Improve Screening Among African American Men', 'orgStudyIdInfo': {'id': 'R44CA246899', 'link': 'https://reporter.nih.gov/quickSearch/R44CA246899', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRC mHealth intervention', 'description': 'Experimental group participants will have access to the CRC mHealth intervention.', 'interventionNames': ['Behavioral: CRC mHealth']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Education', 'description': 'Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'CRC mHealth', 'type': 'BEHAVIORAL', 'description': 'Participants receive text messages that contain information about colorectal cancer and screening. Some text messages include links to videos that are intended to reduce barriers to colorectal cancer screening. Other text messages include links to brief web-based assessments. Responses to assessment questions are used to make sure each man receives only the information relevant to his needs. The main educational content is completed in the first 6 weeks. Additional educational and motivation text messages continue for up to 4 more months if a participant reports not having completed colorectal cancer screening.', 'armGroupLabels': ['CRC mHealth intervention']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Participants receive text messages that include links to videos and/or brochures developed by the Centers for Disease Control. This information is designed to educate the public about colorectal cancer and motivate screening. Text messages are sent every 2-3 days for 6 weeks.', 'armGroupLabels': ['Control Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22314', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'ISA Associates, Inc.', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}], 'overallOfficials': [{'name': 'Samantha L Leaf, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ISA Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ISA Associates, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-21', 'type': 'RELEASE'}, {'date': '2025-12-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'ISA Associates, Inc.'}}}}