Passive Versus Active Educational Interventions for Melanoma Recognition
NCT ID: NCT04507048
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
560 participants
INTERVENTIONAL
2019-09-01
2020-09-30
Brief Summary
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Detailed Description
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1. ABCD rule. According to this rule, lesions characterized by one of more of the following features: Asymmetry, irregular Borders, Color variegation and Diameter larger than 6 mm, should be considered at risk for malignancy. In order to evaluate Evolution, monitoring strategies have been implemented;
2. "ugly duckling" sign. According to this rule, a suspicious lesion tends to be different from the general nevus pattern of a given patient.
The passive intervention will consist in the administration of a booklet containing the explanation of this two previous clinical rules for early detection of atypical melanocytic lesions. In the active intervention a standardized explanation will be given to the patient by a dermatologist, together with the administration of the booklet.
Efficacy will be evaluated through the completion of a specific test before, immediately after and after one month the administration of the educational intervention.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Passive intervention
Administration of a booklet containing the explanation of 2 clinical rules for early detection of atypical melanocytic lesions: the ABCDE and the "ugly duckling" rules.
Passive educational intervention
Administration of a booklet containing the explanation of 2 clinical rules for early detection of atypical melanocytic lesions: the ABCDE and the "ugly duckling" rules.
Active intervention
A standardized oral explanation will be given to the patient by a dermatologist, together with the administration of a booklet containing written information of 2 clinical rules for detection of melanoma, as the ABCDE and the "ugly duckling" rules.
Active educational intervention
an active educational intervention will be provided in the experimental arm, consisting in the administration of a booklet (passive intervention) + an oral standardized explanation of the booklet given by a trained dermatologist for each center.
Interventions
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Active educational intervention
an active educational intervention will be provided in the experimental arm, consisting in the administration of a booklet (passive intervention) + an oral standardized explanation of the booklet given by a trained dermatologist for each center.
Passive educational intervention
Administration of a booklet containing the explanation of 2 clinical rules for early detection of atypical melanocytic lesions: the ABCDE and the "ugly duckling" rules.
Eligibility Criteria
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Inclusion Criteria
* first visit for skin examination
Exclusion Criteria
18 Years
75 Years
ALL
Yes
Sponsors
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Azienda USL Reggio Emilia - IRCCS
OTHER_GOV
Responsible Party
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Prof.ssa Caterina Longo
Professor
Locations
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Valeria Ciciarelli
L’Aquila, AQ, Italy
Mariachiara Arisi
Brescia, BS, Italy
Giovanni Pellacani
Modena, MO, Italy
Caterina Longo
Reggio Emilia, RE, Italy
Ketty Peris
Rome, RM, Italy
Simone Ribero
Turin, TO, Italy
Elvira Moscarella
Naples, , Italy
Countries
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Other Identifiers
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2019/0075289
Identifier Type: -
Identifier Source: org_study_id