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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 560
- Locations
- 8
- Primary Endpoint
- Rate of lesions correctly evaluated as at risk
Study Overview
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.
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:
- 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;
- "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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
Rate of lesions correctly evaluated as at risk
Time Frame: 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 Outcomes
- Rate of lesions correctly assigned to the proper risk category(30 ± 2 days)
Investigators
Prof.ssa Caterina Longo
Professor
Azienda Unità Sanitaria Locale Reggio Emilia