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A Multicentric Randomized Controlled Trial Comparing the Efficacy of Passive Versus Active Educational Interventions in Increasing the Ability of Laypersons in Recognizing Skin Lesions at Risk for MELAnoma
This study evaluates the efficacy of a passive versus an active educational intervention in increasing the ability of laypersons at low risk for melanoma development, in recognizing atypical skin melanocytic lesions. Patients will be randomized (1:1) to receive the active or the passive intervention.
Almost 60-70% of primary melanomas are first detected by patients or their relatives and not by physicians. Then, it appears imperative to promote public campaigns in order to increase the awareness of laypersons on the most important rules for early identification of atypical skin lesions. The two main clinical rules are: 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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
Yes
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
Start Date
September 1, 2019
Primary Completion Date
September 30, 2020
Completion Date
September 30, 2020
Last Updated
December 2, 2020
560
ACTUAL participants
Active educational intervention
OTHER
Passive educational intervention
OTHER
Lead Sponsor
Azienda USL Reggio Emilia - IRCCS
NCT06061003
NCT06765096
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05729802