Passive Versus Active Educational Interventions for Melanoma Recognition

Melanoma (Skin) Clinical Trial

— PAMela  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507048
• Other study ID #: 2019/0075289
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2020
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Educational Problems
• Melanoma
• Melanoma (Skin)

Intervention

Other:
• Active educational intervention
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.
• 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.

Locations

Country	Name	City	State
Italy	Mariachiara Arisi	Brescia	BS
Italy	Valeria Ciciarelli	L'Aquila	AQ
Italy	Giovanni Pellacani	Modena	MO
Italy	Elvira Moscarella	Naples
Italy	Caterina Longo	Reggio Emilia	RE
Italy	Ketty Peris	Rome	RM
Italy	Simone Ribero	Turin	TO

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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