Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT04069104
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2019-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1849}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-15', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mole identification accuracy', 'timeFrame': 'Day 2', 'description': 'Mole identification accuracy will be reported as the amount of mole correctly identified as either melanoma or typical nevi'}], 'secondaryOutcomes': [{'measure': 'Skin Self Exam Intentions', 'timeFrame': 'Day 2', 'description': 'Self-report measure of intentions to perform a skin self exam. Quantified using a single item indicator with scores ranging from 1-7 with higher scores indicating greater intentions to perform a skin self exam to detect potential melanomas.'}, {'measure': 'Intentions to see a Dermatologist', 'timeFrame': 'Day 2', 'description': 'Self-report measure of intentions to schedule an appointment with a dermatologist to receive a skin cancer exam. Quantified using a single item indicator with scores ranging from 1-7 with higher scores indicating greater intentions to schedule an appointment with a dermatologist.'}, {'measure': 'Skin Self Exam Attitudes', 'timeFrame': 'Day 2', 'description': 'Self-report measure of attitudes towards skin cancer exams. Quantified using the mean of the self report scale with scores ranging from 1-7 with higher scores indicating more positive attitudes towards skin self exams.'}, {'measure': 'Skin Self Exam Beliefs', 'timeFrame': 'Day 2', 'description': 'Self-report measure of beliefs towards skin cancer exams. Quantified using the mean of the self report scales for perceived susceptibility, perceived severity, perceived self-efficacy, and perceived response efficacy with scores ranging from 1-7 with higher scores indicating more strongly held beliefs about skin self exams.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanoma identification'], 'conditions': ['Diagnoses Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate an interactive game designed to increase people's ability to identify cancerous moles."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults living in U.S. who are members of the online panel.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of U.S.\n* At least 18 years old\n* Capable of reading English\n* Member of panel assembled by survey provider\n\nExclusion Criteria:\n\n* Individuals under 18 years old'}, 'identificationModule': {'nctId': 'NCT04069104', 'briefTitle': 'Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification', 'orgStudyIdInfo': {'id': '20190153'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ABCD training with standard feedback', 'description': 'Asymmetry, Border, Color, Diameter (ABCD) training message intervention with standard dermatological feedback', 'interventionNames': ['Behavioral: ABCD Information', 'Behavioral: Standard (clinical) feedback']}, {'label': 'ABCD training with motivational feedback', 'description': 'ABCD training message intervention with dermatological feedback and a motivational message', 'interventionNames': ['Behavioral: ABCD Information', 'Behavioral: Motivational feedback']}, {'label': 'ABCD training with no feedback', 'description': 'ABCD message intervention with no feedback', 'interventionNames': ['Behavioral: ABCD Information']}, {'label': 'UDS method training with standard feedback', 'description': 'Ugly Duckling Sign (UDS) method message intervention with dermatological feedback.', 'interventionNames': ['Behavioral: UDS information', 'Behavioral: Standard (clinical) feedback']}, {'label': 'UDS method training with motivational feedback', 'description': 'UDS message intervention with dermatological feedback and a motivational message.', 'interventionNames': ['Behavioral: UDS information', 'Behavioral: Motivational feedback']}, {'label': 'UDS training with no feedback', 'description': 'UDS message intervention with no feedback.', 'interventionNames': ['Behavioral: UDS information']}, {'label': 'ABCD-F training with standard feedback', 'description': 'ABCD-F intervention with dermatological feedback.', 'interventionNames': ['Behavioral: ABCD Information', 'Behavioral: UDS information', 'Behavioral: Standard (clinical) feedback']}, {'label': 'ABCD-F training with motivational feedback', 'description': 'ABCD-F intervention with dermatological feedback and a motivational message.', 'interventionNames': ['Behavioral: ABCD Information', 'Behavioral: UDS information', 'Behavioral: Motivational feedback']}, {'label': 'ABCD-F training with no feedback', 'description': 'ABCD-F intervention with no feedback.', 'interventionNames': ['Behavioral: ABCD Information', 'Behavioral: UDS information']}, {'label': 'No message intervention with standard feedback', 'description': 'No message intervention, but with dermatological feedback.', 'interventionNames': ['Behavioral: Standard (clinical) feedback']}, {'label': 'No message intervention with motivational feedback', 'description': 'No message intervention, but with dermatological feedback and a motivational message.', 'interventionNames': ['Behavioral: Motivational feedback']}, {'label': 'No message intervention with no feedback', 'description': 'No message intervention and no feedback. True control.'}], 'interventions': [{'name': 'ABCD Information', 'type': 'BEHAVIORAL', 'description': 'The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.', 'armGroupLabels': ['ABCD training with motivational feedback', 'ABCD training with no feedback', 'ABCD training with standard feedback', 'ABCD-F training with motivational feedback', 'ABCD-F training with no feedback', 'ABCD-F training with standard feedback']}, {'name': 'UDS information', 'type': 'BEHAVIORAL', 'description': 'The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.', 'armGroupLabels': ['ABCD-F training with motivational feedback', 'ABCD-F training with no feedback', 'ABCD-F training with standard feedback', 'UDS method training with motivational feedback', 'UDS method training with standard feedback', 'UDS training with no feedback']}, {'name': 'Standard (clinical) feedback', 'type': 'BEHAVIORAL', 'description': 'Feedback on mole identification task provided by a dermatologist.', 'armGroupLabels': ['ABCD training with standard feedback', 'ABCD-F training with standard feedback', 'No message intervention with standard feedback', 'UDS method training with standard feedback']}, {'name': 'Motivational feedback', 'type': 'BEHAVIORAL', 'description': 'Feedback on mole identification task provided by a dermatologist plus exposure to a motivational fear appeal message designed to increase skin self exam intentions.', 'armGroupLabels': ['ABCD training with motivational feedback', 'ABCD-F training with motivational feedback', 'No message intervention with motivational feedback', 'UDS method training with motivational feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}], 'overallOfficials': [{'name': 'Nicholas Carcioppolo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Co-Principal Investigator'}, {'name': 'Soyoon Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Co-Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nicholas Carcioppolo', 'investigatorAffiliation': 'University of Miami'}}}}