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
1 other identifier
interventional
560
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 1, 2020
CompletedFirst Posted
Study publicly available on registry
August 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedDecember 2, 2020
December 1, 2020
1.1 years
February 1, 2020
December 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Rate of lesions correctly assigned to the proper risk category
30 ± 2 days
Study Arms (2)
Passive intervention
ACTIVE COMPARATORAdministration of a booklet containing the explanation of 2 clinical rules for early detection of atypical melanocytic lesions: the ABCDE and the "ugly duckling" rules.
Active intervention
EXPERIMENTALA 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- no personal or family history for melanoma;
- first visit for skin examination
You may not qualify if:
- patients referring to know and to be already confident in the use of at least one of the tested rules.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Valeria Ciciarelli
L’Aquila, AQ, Italy
Mariachiara Arisi
Brescia, BS, Italy
Giovanni Pellacani
Modena, MO, Italy
Caterina Longo
Reggio Emilia, RE, 42124, Italy
Ketty Peris
Rome, RM, Italy
Simone Ribero
Turin, TO, Italy
Elvira Moscarella
Naples, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 1, 2020
First Posted
August 10, 2020
Study Start
September 1, 2019
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
December 2, 2020
Record last verified: 2020-12