Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-02-20 @ 4:36 PM
Study NCT ID:
NCT03057327
Status:
COMPLETED
Last Update Posted:
2017-10-09
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Early Detection of Melanoma During the Mammography Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'sequential single group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-06', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Management of decision', 'timeFrame': '2 weeks', 'description': 'Made appointment to see a doctor about the mole'}], 'primaryOutcomes': [{'measure': 'Performance of SSE', 'timeFrame': '4 weeks', 'description': 'Checked Moles'}], 'secondaryOutcomes': [{'measure': 'Questionnaire to identify concerning moles', 'timeFrame': '2 weeks', 'description': 'Found Concerning mole'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma (Skin Cancer)']}, 'descriptionModule': {'briefSummary': 'The proposed study is a pilot and feasibility study designed to develop materials to enhance early detection of melanomas among women at risk to develop melanoma due to indoor tanning, having a family history of melanoma or a personal history of melanoma.\n\nThe hypothesis of this study is that women, who are engaged in health promotion by having mammograms, will be able to assess the personal relevance of skin self-examination (SSE), be interested in learning about SSE and able to implement SSE while they are partially disrobed in the privacy of the changing room in the mammogram facility.', 'detailedDescription': "After patients complete the mammogram, they return to the changing room and put on their clothing. After exiting the changing room in the Lynn Sage Comprehensive Breast Center of Northwestern Medicine/Prentice Women's Hospital and as they are preparing to leave, a research assistant (RA) will screen potential participants to acquire a randomly selected convenience sample of eligible participants (n=200). The first 100 eligible subjects will be asked if they regularly check their moles for concerning features. If the response is yes, then they will be asked if they have found concerning moles and what they did next. Verbal assent will be obtained.\n\nThen the SSE materials will be placed into the changing rooms and the next 100 eligible subjects will be surveyed. The women, who found the information relevant, will be asked if they chose to check their skin while in the changing room. The skin location checked and use of the SSE kit will be ascertained. Women will be asked if they think they have a concerning mole. If the woman does not find a concerning mole, she will be asked if she intends to check her skin again. In addition, she will be asked if she intends to check the skin of family members. Women will be invited to take a brochure to help implement SSE.\n\nThe screening questions are as follows:\n\n1. During your visit for mammography, did you notice any information about checking your skin for melanoma?\n\n \\_\\_\\_Yes \\_\\_ No\n2. Did you think this applied to you? \\_\\_\\_Yes \\_\\_ No\n3. If no, why not? (open ended)\n4. If yes, why? (open ended)\n5. Did you check your skin? (If no, please proceed to question #8)\n\n \\_\\_\\_Yes \\_\\_ No\n6. If yes, did you notice any concerning moles?\n\n * Yes \\_\\_ No\n7. If yes, may we contact you by telephone or email in 2 weeks to see if you have made an appointment to see a dermatologist?\n\n \\_\\_\\_Yes \\_\\_ No If yes, which way do you prefer to be contacted?\n\n Phone \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_(Number) Email \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ (Address)\n8. If no, will you consider checking your skin in the future?\n\n \\_\\_\\_Yes \\_\\_ No\n9. If yes, may we contact you by telephone or email in 2 weeks to see if you have checked your skin for any concerning moles?\n\n \\_\\_\\_Yes \\_\\_ No If yes, which way do you prefer to be contacted?\n\n Phone \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_(Number) Email \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ (Address)\n10. If you found any concerning moles, did you make an appointment to see a dermatologist.\n\n * Yes \\_\\_ No\n\nThe RA will record the responses. Women who checked their skin ,either today or in about 2 weeks, will be invited to participate in a survey about skin location(s) checked, use of the SSE kit, and their decision about the spot on the skin."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Qualitative research: structured interview Women 18 years of age and older, who are waiting to have a mammogram Women agree to a structured interview regarding knowledge of melanoma and awareness of melanoma risk.\n\nFollowing development of a draft of a brochure, women will agree to review a draft and provide comment during a 5 minute interview\n\n* Qualitative research: focus group Women 18 years of age and older Women with a history of regular mammograms Women with a history of indoor tanning, a personal history of skin cancer, and/or a family history of skin cancer Women willing to participate in a 60 minute focus group to assess materials to be provided during the mammogram experience\n* Quantitative research\n\nWomen 18 years of age and older who respond positively to the three screening questions:\n\nNoticed information about checking your skin for melanoma. Thought this information was applicable to them. Checked skin or will consider checking skin in the future.\n\nExclusion Criteria:\n\n* Women who are unable to see to read a newspaper, unable to read English, and who have cognitive impairment causing problems with functioning at a sixth grade reading level or inability to speak.'}, 'identificationModule': {'nctId': 'NCT03057327', 'briefTitle': 'Promoting Early Detection of Melanoma During the Mammography Experience', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Promoting Early Detection of Melanoma During the Mammography Experience', 'orgStudyIdInfo': {'id': 'STU00204685'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'comparator', 'description': 'As women exit the changing are they will be asked if they regularly check their skin for concerning moles', 'interventionNames': ['Other: Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Improve awareness of checking moles', 'description': 'Posters, brochures, and skin self-examination kits consisting of a ruler, and a lighted magnifying lens will be placed into each of the 8 changing rooms in the mammogram facility.', 'interventionNames': ['Behavioral: Improve awareness of checking moles']}], 'interventions': [{'name': 'Improve awareness of checking moles', 'type': 'BEHAVIORAL', 'description': 'Intervention:\n\n1. Improve awareness Each of the eight changing rooms will have a large mirror that can be used to see the face and chest. Each room will be equipped with a poster, brochures and the SSE kit consisting of the laminated card with a ruler on one edge and the magnifying lens will be fastened to the wall on a cord.\n2. Provide education The subject may chose to read the poster and a brochure. c) A woman research assistant will perform in-person exit interviews with participants to ascertain if women noticed the poster, and found the information relevant.', 'armGroupLabels': ['Improve awareness of checking moles']}, {'name': 'Comparator', 'type': 'OTHER', 'description': 'Prior to placing the intervention materials into the changing rooms, 100 eligible subjects will be asked if they regularly check their moles for concerning features. If the response is yes, then they will be asked if they have found concerning moles and what they did next.', 'armGroupLabels': ['comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor of Dermatology', 'investigatorFullName': 'June Robinson', 'investigatorAffiliation': 'Northwestern University'}}}}