Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT07222995
Status:
RECRUITING
Last Update Posted:
2025-11-03
First Post:
2025-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2900}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2025-10-28', 'studyFirstSubmitQcDate': '2025-10-28', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Tanning Score', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Change in self-reported tanning behavior score from baseline to 6 and 12 months.'}, {'measure': 'Number of Sunburns', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Change in self-reported number of sunburns experienced over the past 6 and 12 months.'}, {'measure': 'Skin self-examination (SSE)', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Change in self-reported SSE from baseline to 6 and 12 months.'}, {'measure': 'Physician-patient communication about skin cancer prevention.', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Change in self-reported physician-patient communication from baseline to 6 and 12 months.'}], 'secondaryOutcomes': [{'measure': 'Change in Hours Spent Outside in the Sun', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Change in self-reported average weekly hours spent outdoors in direct sunlight, assessed via questionnaire.'}, {'measure': 'Change in Sun Protection Behaviors', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Change in frequency of sun protection behaviors, including use of sunscreen, wearing protective clothing, and seeking shade, assessed via a composite behavior scale.'}, {'measure': 'Receipt of Total Body Skin Examination (TBSE)', 'timeFrame': '12 months', 'description': 'Proportion of participants who report referral for and receiving a total body skin examination by a healthcare professional during the study period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine how different messages about risk of skin cancer can impact the uptake of skin cancer prevention activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be a patient of any race or ethnicity attending one of the six Tampa Family Health Centers.\n* Be 18 years of age or older.\n* Self-report skin cancer risk behaviors within the past 12 months, including: Intentional sun exposure (e.g., outdoor or indoor tanning) or unintentional sun exposure leading to sunburn.\n* Be willing to complete a baseline questionnaire and provide a saliva sample for MC1R genotyping.\n* Be able to provide informed consent (written or electronic).\n* Prefer English or Spanish for communication and study materials.\n\nExclusion Criteria:\n\n* Do not report any skin cancer risk behaviors (i.e., no tanning or sunburning in the past 12 months).\n* Are unwilling or unable to complete the baseline assessment or return the saliva kit.\n* Decline to provide informed consent.\n* Are under 18 years of age.'}, 'identificationModule': {'nctId': 'NCT07222995', 'briefTitle': 'Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'A Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in Federal Qualified Health Centers', 'orgStudyIdInfo': {'id': 'MCC-23436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Precision Prevention Intervention', 'description': 'Participants receive personalized skin cancer prevention materials based on MC1R genetic risk.', 'interventionNames': ['Behavioral: Precision Prevention Booklet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Prevention', 'description': 'Participants receive standard skin cancer prevention materials.', 'interventionNames': ['Behavioral: Standard Prevention Booklet']}, {'type': 'NO_INTERVENTION', 'label': 'Non-Intervention', 'description': 'Participants who do not return saliva kits will not receive intervention materials but will complete follow-up assessments.'}], 'interventions': [{'name': 'Precision Prevention Booklet', 'type': 'BEHAVIORAL', 'description': 'Precision prevention booklet anchored in their MC1R risk that incorporates gold-standard risk communication strategies, including visual risk representations and simple language.', 'armGroupLabels': ['Precision Prevention Intervention']}, {'name': 'Standard Prevention Booklet', 'type': 'BEHAVIORAL', 'description': 'Standard materials are similar in content to the precision prevention booklet but without any reference to MC1R risk.', 'armGroupLabels': ['Standard Prevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter Kanetsky, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Margaret Byrne, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Susan Vadaparampil, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Rania Abdulla', 'role': 'CONTACT', 'email': 'Rania.Abdulla@moffitt.org', 'phone': '813-745-6813'}], 'overallOfficials': [{'name': 'Peter Kanetsky, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}