Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT03564769
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2017-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation Study of SPOTme® Skin Cancer Screenings
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 431}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2017-12-06', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of a physician skin examination', 'timeFrame': 'Baseline', 'description': "Self-report of a physician skin examination will be defined as a health care provider examining the patient's entire body for any sign of skin cancer during the period following patient's receipt of an AAD SPOTme® skin cancer screening to the baseline assessment."}], 'secondaryOutcomes': [{'measure': 'Completion of a physician skin examination', 'timeFrame': '6 months', 'description': "Self-report of a physician skin examination will be defined as a health care provider examining the patient's entire body for any sign of skin cancer during the 3 months prior to the 6-month follow up assessment"}, {'measure': 'Patient thorough skin self-examination (TSSE)', 'timeFrame': '6 months', 'description': 'Self-report of patient thorough skin self-examination (TSSE) will be defined as performing at least one TSSE during the 3 months prior to the 6-month follow up assessment'}, {'measure': 'Patient attitude towards sun protection', 'timeFrame': '6 months', 'description': 'Self-report of patient attitude towards use of sun protection will be defined by likelihood of engaging in sun protection practices in the year following the 6-month follow up assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['screening'], 'conditions': ['Skin Cancer']}, 'descriptionModule': {'briefSummary': "This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.", 'detailedDescription': "Despite tremendous growth in both the interest and volume of skin cancer screenings at the national level, the actual utility and impact of the AAD SPOT me™ skin cancer screening programs have not been fully evaluated. This study will address this knowledge gap. Early detection is vital in the fight against skin cancer, the most common cancer in the United States. While the effects of skin cancer can be devastating, this disease is highly treatable when detected early.\n\nThis study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participated in the American Academy of Dermatology national screening program in 2016 or 2017\n* Have a presumptive diagnosis (screening, non-confirmed) of melanoma\n* Have provided the AAD with permission to be re-contacted\n* Have provided the AAD with an email address\n* Aged 18 years or older\n* Able to read English\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03564769', 'briefTitle': 'Evaluation Study of SPOTme® Skin Cancer Screenings', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Evaluation Study of SPOTme® Skin Cancer Screenings', 'orgStudyIdInfo': {'id': '17-1668'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm 1', 'description': 'Individuals randomized to intervention group 1 will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017 AND will receive additional skin cancer screening educational materials.', 'interventionNames': ['Behavioral: Intervention Arm', 'Other: AAD SPOTmeⓇ skin cancer screening']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Arm 2', 'description': 'Individuals randomized to intervention group 2 will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017 only.', 'interventionNames': ['Other: AAD SPOTmeⓇ skin cancer screening']}], 'interventions': [{'name': 'Intervention Arm', 'type': 'BEHAVIORAL', 'description': 'Individuals randomized to the intervention group will receive skin cancer screening educational materials.', 'armGroupLabels': ['Intervention Arm 1']}, {'name': 'AAD SPOTmeⓇ skin cancer screening', 'type': 'OTHER', 'description': 'All study participants will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017.', 'armGroupLabels': ['Intervention Arm 1', 'Intervention Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard TH Chan School of Public Health', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Alan Geller, MPH, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard TH Chan School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Academy of Dermatology (AAD)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MPH, RN', 'investigatorFullName': 'Alan Geller', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}