Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04507048
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2020-02-01
Brief Title:
Passive Versus Active Educational Interventions for Melanoma Recognition
Sponsor:
Azienda Unità Sanitaria Locale Reggio Emilia
Organization:
Azienda Unità Sanitaria Locale Reggio Emilia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAMela
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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None