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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive intervention | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active educational intervention | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeria Ciciarelli | L’Aquila | AQ | Italy | |||
| Mariachiara Arisi |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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|
| Passive educational intervention | Other | 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. |
|
| Brescia |
| BS |
| Italy |
| Giovanni Pellacani | Modena | MO | Italy |
| Caterina Longo | Reggio Emilia | RE | 42124 | Italy |
| Ketty Peris | Rome | RM | Italy |
| Simone Ribero | Turin | TO | Italy |
| Elvira Moscarella | Naples | Italy |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |