<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/NCT03246633</url>
  </required_header>
  <id_info>
    <org_study_id>STU00205548</org_study_id>
    <nct_id>NCT03246633</nct_id>
  </id_info>
  <brief_title>Perceptual Expertise Training for Triage of Moles</brief_title>
  <official_title>Perceptual Training to Improve Early Detection of Melanoma by Future Healthcare Providers: to Accuarate Triage of Benign vs. Malignant Pigmented Skin Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess a novel educational mobile and online application which&#xD;
      will use images of pigmented skin lesions with question prompts to train future medical&#xD;
      providers to more accurately detect malignant lesions.&#xD;
&#xD;
      The hypothesis of this study is that this new educational tool will result in higher melanoma&#xD;
      detection rates among future providers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective: To design an online and mobile course in which participants will learn to&#xD;
      triage pigmented lesions as benign or malignant. The course will use images and question&#xD;
      prompts to train users in pattern recognition with the goal of increased diagnostic accuracy.&#xD;
&#xD;
      Secondary Objective: To assess the effectiveness of this course. Students will be asked to&#xD;
      rank their confidence when answering questions at the end of each module and confidence over&#xD;
      time will be tracked. Students will also be asked to complete a post-course survey which will&#xD;
      include an externally validated, 10 question usability scale. Responses will be standardized&#xD;
      and compared across participants.&#xD;
&#xD;
      The study will take place at Northwestern University Feinberg School of Medicine over a 2&#xD;
      year time course. Initially, participants will assess the diameter of pigmented lesions with&#xD;
      and without a ruler incorporated in the image of a pigmented lesion that contains at least&#xD;
      one hair (Phase 1). Next, participants will be asked to complete an online/mobile course with&#xD;
      the goal of learning to triage pigmented lesions as benign or malignant. (Phase 2) (Figure 1)&#xD;
      These will be accessed on personal smart phones and/or computers. The course will consist of&#xD;
      four modules of increasing difficulty. These modules will be completed in (4) 20 minute&#xD;
      sessions over the course of 2 weeks. Each module will pair 4 images of benign lesion with 4&#xD;
      images of melanomas. Each sequential module will incorporate one new type of benign lesion as&#xD;
      well as re-introduced images that were triaged incorrectly in previous modules.&#xD;
&#xD;
      At the end of each module, participants will be asked to rate their confidence in answering&#xD;
      triaging lesions on a scale of 1-10. The change in confidence rating between Module 1 and 4&#xD;
      will be tracked. Students will also be asked to answer a post-test questionnaire designed to&#xD;
      assess: i) the usability of this course ii) effectiveness of this course in helping students&#xD;
      triage benign and malignant lesions. Usability will be assessed with the System Usability&#xD;
      Scale. Effectiveness of the course will be assessed with questions tailored to assess the&#xD;
      specific learning objectives.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">February 6, 2018</completion_date>
  <primary_completion_date type="Actual">February 6, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability of Course</measure>
    <time_frame>18 months</time_frame>
    <description>Usability will be assessed with the System Usability Scale, a widely accepted and validated scale to assess consumer satisfaction with new products</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of Course</measure>
    <time_frame>18 months</time_frame>
    <description>Effectiveness of the course will be assessed with quiz requiring a benign or malignant decision about each image presents</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Lesion; Pigment</condition>
  <condition>Diagnostic Self Evaluation</condition>
  <arm_group>
    <arm_group_label>Perceptual Training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single-Arm study, all participants will receive educational training via online modules and will be assessed after completion of the training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Perceptual Training</intervention_name>
    <description>Participants will assess skin lesions before and after completion of an online/mobile course that has the goal of learning to triage pigmented lesions as benign or malignant. Participants will also help evaluate the usability and effectiveness of the course by completing a questionnaire after completion of the course.</description>
    <arm_group_label>Perceptual Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria for Phase 1&#xD;
&#xD;
        Study participants must:&#xD;
&#xD;
          1. be over the age of 18&#xD;
&#xD;
          2. be currently a medical student , dermatology resident or member of the dermatology&#xD;
             faculty at Northwestern University Feinberg School of Medicine&#xD;
&#xD;
          3. able to consent&#xD;
&#xD;
             Inclusion Criteria for Phase 2&#xD;
&#xD;
             Study participants must:&#xD;
&#xD;
          4. be over the age of 18&#xD;
&#xD;
          5. be currently enrolled in an MD or PA course at Northwestern University Feinberg School&#xD;
             of Medicine&#xD;
&#xD;
          6. able to consent&#xD;
&#xD;
          7. have internet access&#xD;
&#xD;
          8. own and be able to use a smart phone&#xD;
&#xD;
          9. be willing to participate in two online surveys before and after each simulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria for Phases 1 and 2&#xD;
&#xD;
        Participants will be excluded if:&#xD;
&#xD;
          1. Not over 18 years of age&#xD;
&#xD;
          2. Do not have internet access&#xD;
&#xD;
          3. Do not have smart phone access&#xD;
&#xD;
          4. Are not currently enrolled as MD or PA students&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Society, A.C. Melanoma Skin Cancer. 2016.</citation>
  </reference>
  <reference>
    <citation>Reed KB, Brewer JD, Lohse CM, Bringe KE, Pruitt CN, Gibson LE. Increasing incidence of melanoma among young adults: an epidemiological study in Olmsted County, Minnesota. Mayo Clin Proc. 2012 Apr;87(4):328-34. doi: 10.1016/j.mayocp.2012.01.010.</citation>
    <PMID>22469345</PMID>
  </reference>
  <reference>
    <citation>Aviles-Izquierdo JA, Molina-Lopez I, Rodriguez-Lomba E, Marquez-Rodas I, Suarez-Fernandez R, Lazaro-Ochaita P. Who detects melanoma? Impact of detection patterns on characteristics and prognosis of patients with melanoma. J Am Acad Dermatol. 2016 Nov;75(5):967-974. doi: 10.1016/j.jaad.2016.07.009. Epub 2016 Sep 16.</citation>
    <PMID>27645105</PMID>
  </reference>
  <reference>
    <citation>Summaries for patients. Screening for skin cancer: U.S. Preventive Services Task Force recommendation. Ann Intern Med. 2009 Feb 3;150(3):I40. doi: 10.7326/0003-4819-150-3-200902030-00003. No abstract available.</citation>
    <PMID>19189902</PMID>
  </reference>
  <reference>
    <citation>Society, A.C. Skin Exams. 2016.</citation>
  </reference>
  <reference>
    <citation>Thomas L, Tranchand P, Berard F, Secchi T, Colin C, Moulin G. Semiological value of ABCDE criteria in the diagnosis of cutaneous pigmented tumors. Dermatology. 1998;197(1):11-7. doi: 10.1159/000017969.</citation>
    <PMID>9693179</PMID>
  </reference>
  <reference>
    <citation>Scope A, Dusza SW, Halpern AC, Rabinovitz H, Braun RP, Zalaudek I, Argenziano G, Marghoob AA. The &quot;ugly duckling&quot; sign: agreement between observers. Arch Dermatol. 2008 Jan;144(1):58-64. doi: 10.1001/archdermatol.2007.15.</citation>
    <PMID>18209169</PMID>
  </reference>
  <reference>
    <citation>Herschorn A. Dermoscopy for melanoma detection in family practice. Can Fam Physician. 2012 Jul;58(7):740-5, e372-8.</citation>
    <PMID>22859635</PMID>
  </reference>
  <reference>
    <citation>Brochez L, Verhaeghe E, Bleyen L, Naeyaert JM. Diagnostic ability of general practitioners and dermatologists in discriminating pigmented skin lesions. J Am Acad Dermatol. 2001 Jun;44(6):979-86. doi: 10.1067/mjd.2001.113442.</citation>
    <PMID>11369910</PMID>
  </reference>
  <reference>
    <citation>Wender RC. Barriers to effective skin cancer detection. Cancer. 1995 Jan 15;75(2 Suppl):691-8. doi: 10.1002/1097-0142(19950115)75:2+3.0.co;2-g.</citation>
    <PMID>7804996</PMID>
  </reference>
  <reference>
    <citation>Cassileth BR, Clark WH Jr, Lusk EJ, Frederick BE, Thompson CJ, Walsh WP. How well do physicians recognize melanoma and other problem lesions? J Am Acad Dermatol. 1986 Apr;14(4):555-60. doi: 10.1016/s0190-9622(86)70068-6.</citation>
    <PMID>3958271</PMID>
  </reference>
  <reference>
    <citation>Oliveria SA, Heneghan MK, Cushman LF, Ughetta EA, Halpern AC. Skin cancer screening by dermatologists, family practitioners, and internists: barriers and facilitating factors. Arch Dermatol. 2011 Jan;147(1):39-44. doi: 10.1001/archdermatol.2010.414.</citation>
    <PMID>21242390</PMID>
  </reference>
  <reference>
    <citation>Garg A, Wang J, Reddy SB, Powers J, Jacob R, Powers M, Biello K, Cayce R, Savory S, Belazarian L, Domingues E, Korzenko A, Wilson L, Grant-Kels JM, George P, Robinson-Bostom L, Trotter SC, Geller AC. The Integrated Skin Exam film: an educational intervention to promote early detection of melanoma by medical students. J Am Acad Dermatol. 2014 Jan;70(1):115-9. doi: 10.1016/j.jaad.2013.09.028. Epub 2013 Nov 9.</citation>
    <PMID>24220723</PMID>
  </reference>
  <reference>
    <citation>Lofgreen S, Lehrer M, Bennett P, Garg A, Dunnick CA. Integrating The Integrated Skin Exam film into medical education. Dermatol Online J. 2016 Nov 15;22(11):13030/qt5pk3n658.</citation>
    <PMID>28329558</PMID>
  </reference>
  <reference>
    <citation>Eide MJ, Asgari MM, Fletcher SW, Geller AC, Halpern AC, Shaikh WR, Li L, Alexander GL, Altschuler A, Dusza SW, Marghoob AA, Quigley EA, Weinstock MA; INFORMED (INternet course FOR Melanoma Early Detection) Group. Effects on skills and practice from a web-based skin cancer course for primary care providers. J Am Board Fam Med. 2013 Nov-Dec;26(6):648-57. doi: 10.3122/jabfm.2013.06.130108.</citation>
    <PMID>24204061</PMID>
  </reference>
  <reference>
    <citation>Jain N, Anderson MJ, Patel P, Blatt H, Davis L, Bierman J, McGaghie W, Brucker JB, Martini M, Robinson JK. Melanoma simulation model: promoting opportunistic screening and patient counseling. JAMA Dermatol. 2013 Jun;149(6):710-6. doi: 10.1001/jamadermatol.2013.2882.</citation>
    <PMID>23552462</PMID>
  </reference>
  <reference>
    <citation>Brooke, J., SUS: A</citation>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>September 21, 2018</last_update_submitted>
  <last_update_submitted_qc>September 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>June Robinson</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <!-- 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/NCT03246633
org study id: STU00205548
nct id: NCT03246633
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess a novel educational mobile and online application which
      will use images of pigmented skin lesions with question prompts to train future medical
      providers to more accurately detect malignant lesions.

      The hypothesis of this study is that this new educational tool will result in higher melanoma
      detection rates among future providers.
Primary Objective: To design an online and mobile course in which participants will learn to
      triage pigmented lesions as benign or malignant. The course will use images and question
      prompts to train users in pattern recognition with the goal of increased diagnostic accuracy.

      Secondary Objective: To assess the effectiveness of this course. Students will be asked to
      rank their confidence when answering questions at the end of each module and confidence over
      time will be tracked. Students will also be asked to complete a post-course survey which will
      include an externally validated, 10 question usability scale. Responses will be standardized
      and compared across participants.

      The study will take place at Northwestern University Feinberg School of Medicine over a 2
      year time course. Initially, participants will assess the diameter of pigmented lesions with
      and without a ruler incorporated in the image of a pigmented lesion that contains at least
      one hair (Phase 1). Next, participants will be asked to complete an online/mobile course with
      the goal of learning to triage pigmented lesions as benign or malignant. (Phase 2) (Figure 1)
      These will be accessed on personal smart phones and/or computers. The course will consist of
      four modules of increasing difficulty. These modules will be completed in (4) 20 minute
      sessions over the course of 2 weeks. Each module will pair 4 images of benign lesion with 4
      images of melanomas. Each sequential module will incorporate one new type of benign lesion as
      well as re-introduced images that were triaged incorrectly in previous modules.

      At the end of each module, participants will be asked to rate their confidence in answering
      triaging lesions on a scale of 1-10. The change in confidence rating between Module 1 and 4
      will be tracked. Students will also be asked to answer a post-test questionnaire designed to
      assess: i) the usability of this course ii) effectiveness of this course in helping students
      triage benign and malignant lesions. Usability will be assessed with the System Usability
      Scale. Effectiveness of the course will be assessed with questions tailored to assess the
      specific learning objectives.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Usability of Course
time frame: 18 months
description: Usability will be assessed with the System Usability Scale, a widely accepted and validated scale to assess consumer satisfaction with new products
measure: Effectiveness of Course
time frame: 18 months
description: Effectiveness of the course will be assessed with quiz requiring a benign or malignant decision about each image presents
arm group label: Perceptual Training
arm group type: Other
description: Single-Arm study, all participants will receive educational training via online modules and will be assessed after completion of the training.
intervention type: Other
intervention name: Perceptual Training
description: Participants will assess skin lesions before and after completion of an online/mobile course that has the goal of learning to triage pigmented lesions as benign or malignant. Participants will also help evaluate the usability and effectiveness of the course by completing a questionnaire after completion of the course.
arm group label: Perceptual Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Society, A.C. Melanoma Skin Cancer. 2016.
citation: Reed KB, Brewer JD, Lohse CM, Bringe KE, Pruitt CN, Gibson LE. Increasing incidence of melanoma among young adults: an epidemiological study in Olmsted County, Minnesota. Mayo Clin Proc. 2012 Apr;87(4):328-34. doi: 10.1016/j.mayocp.2012.01.010.
PMID: 22469345
citation: Aviles-Izquierdo JA, Molina-Lopez I, Rodriguez-Lomba E, Marquez-Rodas I, Suarez-Fernandez R, Lazaro-Ochaita P. Who detects melanoma? Impact of detection patterns on characteristics and prognosis of patients with melanoma. J Am Acad Dermatol. 2016 Nov;75(5):967-974. doi: 10.1016/j.jaad.2016.07.009. Epub 2016 Sep 16.
PMID: 27645105
citation: Summaries for patients. Screening for skin cancer: U.S. Preventive Services Task Force recommendation. Ann Intern Med. 2009 Feb 3;150(3):I40. doi: 10.7326/0003-4819-150-3-200902030-00003. No abstract available.
PMID: 19189902
citation: Society, A.C. Skin Exams. 2016.
citation: Thomas L, Tranchand P, Berard F, Secchi T, Colin C, Moulin G. Semiological value of ABCDE criteria in the diagnosis of cutaneous pigmented tumors. Dermatology. 1998;197(1):11-7. doi: 10.1159/000017969.
PMID: 9693179
citation: Scope A, Dusza SW, Halpern AC, Rabinovitz H, Braun RP, Zalaudek I, Argenziano G, Marghoob AA. The "ugly duckling" sign: agreement between observers. Arch Dermatol. 2008 Jan;144(1):58-64. doi: 10.1001/archdermatol.2007.15.
PMID: 18209169
citation: Herschorn A. Dermoscopy for melanoma detection in family practice. Can Fam Physician. 2012 Jul;58(7):740-5, e372-8.
PMID: 22859635
citation: Brochez L, Verhaeghe E, Bleyen L, Naeyaert JM. Diagnostic ability of general practitioners and dermatologists in discriminating pigmented skin lesions. J Am Acad Dermatol. 2001 Jun;44(6):979-86. doi: 10.1067/mjd.2001.113442.
PMID: 11369910
citation: Wender RC. Barriers to effective skin cancer detection. Cancer. 1995 Jan 15;75(2 Suppl):691-8. doi: 10.1002/1097-0142(19950115)75:2+3.0.co;2-g.
PMID: 7804996
citation: Cassileth BR, Clark WH Jr, Lusk EJ, Frederick BE, Thompson CJ, Walsh WP. How well do physicians recognize melanoma and other problem lesions? J Am Acad Dermatol. 1986 Apr;14(4):555-60. doi: 10.1016/s0190-9622(86)70068-6.
PMID: 3958271
citation: Oliveria SA, Heneghan MK, Cushman LF, Ughetta EA, Halpern AC. Skin cancer screening by dermatologists, family practitioners, and internists: barriers and facilitating factors. Arch Dermatol. 2011 Jan;147(1):39-44. doi: 10.1001/archdermatol.2010.414.
PMID: 21242390
citation: Garg A, Wang J, Reddy SB, Powers J, Jacob R, Powers M, Biello K, Cayce R, Savory S, Belazarian L, Domingues E, Korzenko A, Wilson L, Grant-Kels JM, George P, Robinson-Bostom L, Trotter SC, Geller AC. The Integrated Skin Exam film: an educational intervention to promote early detection of melanoma by medical students. J Am Acad Dermatol. 2014 Jan;70(1):115-9. doi: 10.1016/j.jaad.2013.09.028. Epub 2013 Nov 9.
PMID: 24220723
citation: Lofgreen S, Lehrer M, Bennett P, Garg A, Dunnick CA. Integrating The Integrated Skin Exam film into medical education. Dermatol Online J. 2016 Nov 15;22(11):13030/qt5pk3n658.
PMID: 28329558
citation: Eide MJ, Asgari MM, Fletcher SW, Geller AC, Halpern AC, Shaikh WR, Li L, Alexander GL, Altschuler A, Dusza SW, Marghoob AA, Quigley EA, Weinstock MA; INFORMED (INternet course FOR Melanoma Early Detection) Group. Effects on skills and practice from a web-based skin cancer course for primary care providers. J Am Board Fam Med. 2013 Nov-Dec;26(6):648-57. doi: 10.3122/jabfm.2013.06.130108.
PMID: 24204061
citation: Jain N, Anderson MJ, Patel P, Blatt H, Davis L, Bierman J, McGaghie W, Brucker JB, Martini M, Robinson JK. Melanoma simulation model: promoting opportunistic screening and patient counseling. JAMA Dermatol. 2013 Jun;149(6):710-6. doi: 10.1001/jamadermatol.2013.2882.
PMID: 23552462
citation: Brooke, J., SUS: A
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: June Robinson
investigator title: MD