Clinical trial NCT04507048: Passive Versus Active Educational Interventions for Melanoma Recognition
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Melanoma (Skin)
Keywords: educational intervention
melanoma
clinical trial
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2020-08-10
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of lesions correctly evaluated as at risk
timeFrame: 30 ± 2 days
Secondary outcomes:
measure: Rate of lesions correctly assigned to the proper risk category
timeFrame: 30 ± 2 days
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Valeria Ciciarelli
state: AQ
city: Brescia
country: Italy
facility: Mariachiara Arisi
state: BS
city: Modena
country: Italy
facility: Giovanni Pellacani
state: MO
city: Reggio Emilia
country: Italy
facility: Caterina Longo
state: RE
city: Rome
country: Italy
facility: Ketty Peris
state: RM
city: Turin
country: Italy
facility: Simone Ribero
state: TO
city: Naples
country: Italy
facility: Elvira Moscarella
Study officials:
References: