<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04507048</url>
  </required_header>
  <id_info>
    <org_study_id>2019/0075289</org_study_id>
    <nct_id>NCT04507048</nct_id>
  </id_info>
  <brief_title>Passive Versus Active Educational Interventions for Melanoma Recognition</brief_title>
  <acronym>PAMela</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Unità Sanitaria Locale Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Unità Sanitaria Locale Reggio Emilia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy of a passive versus an active educational intervention in&#xD;
      increasing the ability of laypersons at low risk for melanoma development, in recognizing&#xD;
      atypical skin melanocytic lesions. Patients will be randomized (1:1) to receive the active or&#xD;
      the passive intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Almost 60-70% of primary melanomas are first detected by patients or their relatives and not&#xD;
      by physicians. Then, it appears imperative to promote public campaigns in order to increase&#xD;
      the awareness of laypersons on the most important rules for early identification of atypical&#xD;
      skin lesions. The two main clinical rules are:&#xD;
&#xD;
        1. ABCD rule. According to this rule, lesions characterized by one of more of the following&#xD;
           features: Asymmetry, irregular Borders, Color variegation and Diameter larger than 6 mm,&#xD;
           should be considered at risk for malignancy. In order to evaluate Evolution, monitoring&#xD;
           strategies have been implemented;&#xD;
&#xD;
        2. &quot;ugly duckling&quot; sign. According to this rule, a suspicious lesion tends to be different&#xD;
           from the general nevus pattern of a given patient.&#xD;
&#xD;
      The passive intervention will consist in the administration of a booklet containing the&#xD;
      explanation of this two previous clinical rules for early detection of atypical melanocytic&#xD;
      lesions. In the active intervention a standardized explanation will be given to the patient&#xD;
      by a dermatologist, together with the administration of the booklet.&#xD;
&#xD;
      Efficacy will be evaluated through the completion of a specific test before, immediately&#xD;
      after and after one month the administration of the educational intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of lesions correctly evaluated as at risk</measure>
    <time_frame>30 ± 2 days</time_frame>
    <description>Change at t1 and t2 from baseline (t0) in lesions at risk correctly identified, comparing passive and active educational intervention arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of lesions correctly assigned to the proper risk category</measure>
    <time_frame>30 ± 2 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">560</enrollment>
  <condition>Educational Problems</condition>
  <condition>Melanoma (Skin)</condition>
  <arm_group>
    <arm_group_label>Passive intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of a booklet containing the explanation of 2 clinical rules for early detection of atypical melanocytic lesions: the ABCDE and the &quot;ugly duckling&quot; rules.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 &quot;ugly duckling&quot; rules.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active educational intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Active intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Passive educational intervention</intervention_name>
    <description>Administration of a booklet containing the explanation of 2 clinical rules for early detection of atypical melanocytic lesions: the ABCDE and the &quot;ugly duckling&quot; rules.</description>
    <arm_group_label>Passive intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no personal or family history for melanoma;&#xD;
&#xD;
          -  first visit for skin examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients referring to know and to be already confident in the use of at least one of&#xD;
             the tested rules.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Valeria Ciciarelli</name>
      <address>
        <city>L'Aquila</city>
        <state>AQ</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mariachiara Arisi</name>
      <address>
        <city>Brescia</city>
        <state>BS</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Giovanni Pellacani</name>
      <address>
        <city>Modena</city>
        <state>MO</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caterina Longo</name>
      <address>
        <city>Reggio Emilia</city>
        <state>RE</state>
        <zip>42124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ketty Peris</name>
      <address>
        <city>Rome</city>
        <state>RM</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Simone Ribero</name>
      <address>
        <city>Turin</city>
        <state>TO</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elvira Moscarella</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>February 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>December 1, 2020</last_update_submitted>
  <last_update_submitted_qc>December 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Unità Sanitaria Locale Reggio Emilia</investigator_affiliation>
    <investigator_full_name>Prof.ssa Caterina Longo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>educational intervention</keyword>
  <keyword>melanoma</keyword>
  <keyword>clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04507048
org study id: 2019/0075289
nct id: NCT04507048
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rate of lesions correctly evaluated as at risk
time frame: 30 ± 2 days
description: Change at t1 and t2 from baseline (t0) in lesions at risk correctly identified, comparing passive and active educational intervention arms.
measure: Rate of lesions correctly assigned to the proper risk category
time frame: 30 ± 2 days
description: 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.
arm group label: Passive intervention
arm group type: Active Comparator
description: 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.
arm group label: Active intervention
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: Active educational intervention
description: 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.
arm group label: Active intervention
intervention type: Other
intervention name: Passive educational intervention
description: 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.
arm group label: Passive intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Unità Sanitaria Locale Reggio Emilia
investigator full name: Prof.ssa Caterina Longo
investigator title: Professor
mesh term: Melanoma