Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-02 @ 1:11 PM
Study NCT ID:
NCT03512457
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2018-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Skin Self-Examination Education During Mammography
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'june-robinson@northwestern.edu', 'phone': '312-503-5941', 'title': 'Dr. June Robinson', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations of our study include a relatively short duration of follow-up resulting in a modest number of incident invasive melanoma cases and a lack of participant blinding of allocation to intervention arms.'}}, 'adverseEventsModule': {'timeFrame': '7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intensive Intervention', 'description': 'Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week by telephone call, text message or email to perform SSE.\n\nIntensive Intervention: Women view an educational poster in changing room, and they receive a brochure.', 'otherNumAtRisk': 195, 'deathsNumAtRisk': 195, 'otherNumAffected': 0, 'seriousNumAtRisk': 195, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Minimal Intervention', 'description': 'Participants receive brochure, card advising how to make an appointment with dermatology.\n\nMinimal Intervention: Women view an educational poster in changing room, and they receive a brochure.', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 0, 'seriousNumAtRisk': 225, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Performed a Skin Self-Examination at 3-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Intervention', 'description': 'Women who received an educational brochure and a 1-week reminder call or email to complete SSE'}, {'id': 'OG001', 'title': 'Educational Intervention', 'description': 'Women who only received a brochure.'}], 'classes': [{'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value of \\<0.05 is the threshold for statistical significance. The hypothesis was that more women randomized to the intensive intervention would perform skin self-examination.', 'groupDescription': 'change from baseline to 3 months in performance of skin self-examination Parallel: response rate', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Chi-Squared is equal to 1.58, with a P-Value of 0.12.', 'nonInferiorityComment': 'Chi-square'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-months', 'description': 'The percentage of participants that performed skin self-examination at the 3-month time interval.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women performing skin self-examination as reported 3 months after the intervention'}, {'type': 'SECONDARY', 'title': 'Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Intervention', 'description': 'Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.\n\nIntensive Intervention: Women view an educational poster in changing room, and they receive a brochure.'}, {'id': 'OG001', 'title': 'Minimal Intervention', 'description': 'Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.\n\nMinimal Intervention: Women view an educational poster in changing room, and they receive a brochure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'results of skin clinical examination and biopsy of clinically suspicious moles', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Types of lesions in the following categories: Benign nevus, seborrheic keratosis, lentigo, dermatofibroma, atypical nevus. melanoma'}], 'paramType': 'NUMBER', 'timeFrame': '7-months', 'description': 'The total number of melanomas identified by a dermatologist in women who found a concerning mole', 'unitOfMeasure': 'Melanomas', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who found a concerning mole at month 1 and month 3 and proceeded to have a skin examination by a dermatologist'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intensive Intervention', 'description': 'Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE.\n\nIntensive Intervention: Women view an educational poster in changing room, and they receive a brochure.'}, {'id': 'FG001', 'title': 'Minimal Intervention', 'description': 'Participants receive brochure, card advising how to make an appointment with dermatology.\n\nMinimal Intervention: Women view an educational poster in changing room, and they receive a brochure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '195'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '40'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intensive Intervention', 'description': 'Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE.\n\nIntensive Intervention: Women view an educational poster in changing room, and they receive a brochure.'}, {'id': 'BG001', 'title': 'Minimal Intervention', 'description': 'Participants receive brochure, card advising how to make an appointment with dermatology.\n\nMinimal Intervention: Women view an educational poster in changing room, and they receive a brochure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '52.4', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants who had ever conducted skin self-examination prior to study participation', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Women having a screening mammogram completed a baseline self-report of prior skin self-examination prior to the intervention'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-18', 'size': 287513, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-11T17:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'study arm not disclosed'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-23', 'studyFirstSubmitDate': '2018-04-11', 'resultsFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2018-04-18', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-23', 'studyFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Performed a Skin Self-Examination at 3-months', 'timeFrame': '3-months', 'description': 'The percentage of participants that performed skin self-examination at the 3-month time interval.'}], 'secondaryOutcomes': [{'measure': 'Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion', 'timeFrame': '7-months', 'description': 'The total number of melanomas identified by a dermatologist in women who found a concerning mole'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanoma', 'Skin self-examination', 'mammogram'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '29234713', 'type': 'RESULT', 'citation': 'Rzepecki AK, Jain N, Ali Y, Chavez L, Choi J, Schlosser B, Liko-Hazizi E, Friedewald SM, Robinson JK. Promoting early detection of melanoma during the mammography experience. Int J Womens Dermatol. 2017 Jul 5;3(4):195-200. doi: 10.1016/j.ijwd.2017.06.002. eCollection 2017 Dec.'}, {'pmid': '32328556', 'type': 'RESULT', 'citation': 'Robinson JK, Perez M, Abou-El-Seoud D, Kim K, Brown Z, Liko-Hazizi E, Friedewald SM, Kwasny M, Spring B. Targeted Melanoma Screening: Risk Self-Assessment and Skin Self-Examination Education Delivered During Mammography of Women. JNCI Cancer Spectr. 2019 Jun 28;3(3):pkz047. doi: 10.1093/jncics/pkz047. eCollection 2019 Sep.'}, {'pmid': '32090289', 'type': 'DERIVED', 'citation': 'Robinson JK, Brown Z, Spring B. Melanoma Skin Self-Examination Education During Mammography: Health Burden of Women Impairs Implementation. J Cancer Educ. 2021 Aug;36(4):858-864. doi: 10.1007/s13187-020-01714-4.'}]}, 'descriptionModule': {'briefSummary': 'The skin self-examination for melanoma (SSE) educational materials were developed with the input provided by women undergoing screening mammograms. The investigators seek to evaluate the performance of SSE by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening examination by a dermatologist after reviewing the materials received during the mammogram visit. The purpose of this study is to enhance the early detection of melanoma among women who are engaging in health promotion by having mammograms. The investigators specifically aim to evaluate the performance of SSE by women, who receive information during their mammogram appointment, and then follow-up with dermatology for a melanoma screening examination.', 'detailedDescription': "The proposed study is the second phase of a project assessing the feasibility and effectiveness of enhancing the early detection of melanomas among women, who are engaging in health promotion by having mammograms. The initial phase of the project framed risk messages, developed posters and brochures with the input provided by women undergoing screening mammograms, and assessed the feasibility of delivering the program during the mammogram visit at the Lynn Sage Comprehensive Breast Center of Northwestern Medicine/ Prentice Women's Hospital. The investigators seek to evaluate performance of skin self-examination (SSE) by women, who receive information during their mammogram appointment, and follow-up with dermatology for a melanoma screening examination. In the second phase, a more intensive intervention in which women will not only receive information about SSE, but will also receive a reminder to perform SSE one week after the screening mammogram and information on how to schedule an appointment with dermatology will be provided. The number of women who perform SSE at home and find a concerning mole (lesion), number who see a dermatologist, and number who have a concerning lesion biopsied will be compared in two arms of the study 1) women who receive the intensive intervention 2) women who receive the informational brochure about SSE alone. The hypothesis is that women who receive more the intensive educational intervention will be more likely to perform SSE at home and schedule a follow-up dermatologist appointment as compared to those who receive the information brochure alone. This project builds upon Robinson's successful SSE training program for melanoma patients that resulted in patients' accurate evaluations of suspicious lesions relative to dermatologists' skin examinations."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women waiting to have a mammogram', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18 years of age or older\n* Waiting to have a mammogram\n\nExclusion Criteria:\n\n* Male'}, 'identificationModule': {'nctId': 'NCT03512457', 'acronym': 'SSE', 'briefTitle': 'Skin Self-Examination Education During Mammography', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Effect of Skin Self-examination Education Delivered During the Mammography Experience.', 'orgStudyIdInfo': {'id': 'STU00207179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive Intervention', 'description': 'Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.', 'interventionNames': ['Behavioral: Intensive Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Minimal Intervention', 'description': 'Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.', 'interventionNames': ['Behavioral: Minimal Intervention']}], 'interventions': [{'name': 'Minimal Intervention', 'type': 'BEHAVIORAL', 'description': 'Women view an educational poster in changing room, and they receive a brochure.', 'armGroupLabels': ['Minimal Intervention']}, {'name': 'Intensive Intervention', 'type': 'BEHAVIORAL', 'description': 'Women view an educational poster in changing room, and they receive a brochure.', 'armGroupLabels': ['Intensive Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine Department of Dermatology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'June K. Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sarah M. Friedewald, MD', 'class': 'UNKNOWN'}, {'name': 'Jennifer N. Choi, MD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor of Dermatology', 'investigatorFullName': 'June Robinson', 'investigatorAffiliation': 'Northwestern University'}}}}