Passive Versus Active Educational Interventions for Melanoma Recognition

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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; 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.

Official Title
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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

Conditions
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Educational Problems, Melanoma (Skin)

Intervention / Treatment
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* Other: Active educational intervention
* Other: Passive educational intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no personal or family history for melanoma; first visit for skin examination Exclusion Criteria: patients referring to know and to be already confident in the use of at least one of the tested rules.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Passive intervention<br>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. | Other: Passive educational intervention<br>* 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.<br>|
| Experimental: Active intervention<br>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. | Other: Active educational intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of lesions correctly evaluated as at risk | Change at t1 and t2 from baseline (t0) in lesions at risk correctly identified, comparing passive and active educational intervention arms. | 30 ± 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of lesions correctly assigned to the proper risk category | Change at t1 and t2 from baseline (t0) in lesions correctly assigned to the proper risk category (low, intermediate, high), comparing passive and active educational intervention arms. | 30 ± 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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educational intervention, melanoma, clinical trial