Passive Versus Active Educational Interventions for Melanoma Recognition

Not Applicable

Completed

• Conditions: Educational Problems; Melanoma (Skin)
• Interventions: Other: Active educational intervention; Other: Passive educational intervention

• Registration Number: NCT04507048
• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

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.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-02-01
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active intervention	Active educational 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.
Passive intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of lesions correctly assigned to the proper risk category	30 ± 2 days	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.

Trial Locations

Locations (7)

Valeria Ciciarelli; 🇮🇹 L'Aquila, AQ, Italy

Caterina Longo; 🇮🇹 Reggio Emilia, RE, Italy

Mariachiara Arisi; 🇮🇹 Brescia, BS, Italy

Giovanni Pellacani; 🇮🇹 Modena, MO, Italy

Ketty Peris; 🇮🇹 Rome, RM, Italy

Simone Ribero; 🇮🇹 Turin, TO, Italy

Elvira Moscarella; 🇮🇹 Naples, Italy