Passive Versus Active Educational Interventions for Melanoma Recognition (PAMela)

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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma (Skin); Educational Problems
• Intervention / Treatment: Other: Passive educational intervention; Other: Active educational 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 Type: Interventional
• Enrollment (Actual): 560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy
    • Elvira Moscarella
  • AQ
    • L'Aquila, AQ, Italy
      • Valeria Ciciarelli
  • BS
    • Brescia, BS, Italy
      • Mariachiara Arisi
  • MO
    • Modena, MO, Italy
      • Giovanni Pellacani
  • RE
    • Reggio Emilia, RE, Italy, 42124
      • Caterina Longo
  • RM
    • Rome, RM, Italy
      • Ketty Peris
  • TO
    • Turin, TO, Italy
      • Simone Ribero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Passive 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.	Other: 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.
Experimental: Active 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Unita Sanitaria Locale Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: February 1, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: clinical trial; melanoma; educational intervention
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 2019/0075289

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No