PAMela: Passive Versus Active Educational Interventions for Melanoma Recognition

• Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04507048
• Collaborator: (none)
• Enrollment: 560
• Locations: 7
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site: 80
• Patients Per Site Per Month: 6.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Educational Problems; Melanoma (Skin)	Other: Active educational intervention; Other: Passive educational intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 560 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Sep 30, 2020
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valeria Ciciarelli	L'Aquila	AQ	Italy
2	Mariachiara Arisi	Brescia	BS	Italy
3	Giovanni Pellacani	Modena	MO	Italy
4	Caterina Longo	Reggio Emilia	RE	Italy	42124
5	Ketty Peris	Rome	RM	Italy
6	Simone Ribero	Turin	TO	Italy
7	Elvira Moscarella	Naples		Italy

Sponsors and Collaborators

• Azienda Unità Sanitaria Locale Reggio Emilia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof.ssa Caterina Longo, Professor, Azienda Unità Sanitaria Locale Reggio Emilia
• ClinicalTrials.gov Identifier: NCT04507048
• Other Study ID Numbers: 2019/0075289
• First Posted: Aug 10, 2020
• Last Update Posted: Dec 2, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof.ssa Caterina Longo, Professor, Azienda Unità Sanitaria Locale Reggio Emilia: educational intervention; melanoma; clinical trial
• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of Dec 2, 2020