NCT03246633

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2018

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

July 28, 2017

Last Update Submit

September 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Usability of Course

    Usability will be assessed with the System Usability Scale, a widely accepted and validated scale to assess consumer satisfaction with new products

    18 months

Secondary Outcomes (1)

  • Effectiveness of Course

    18 months

Study Arms (1)

Perceptual Training

OTHER

Single-Arm study, all participants will receive educational training via online modules and will be assessed after completion of the training.

Other: Perceptual Training

Interventions

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.

Perceptual Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study participants must:
  • be over the age of 18
  • be currently a medical student , dermatology resident or member of the dermatology faculty at Northwestern University Feinberg School of Medicine
  • able to consent
  • Study participants must:
  • be over the age of 18
  • be currently enrolled in an MD or PA course at Northwestern University Feinberg School of Medicine
  • able to consent
  • have internet access
  • own and be able to use a smart phone
  • be willing to participate in two online surveys before and after each simulation

You may not qualify if:

  • Participants will be excluded if:
  • Not over 18 years of age
  • Do not have internet access
  • Do not have smart phone access
  • Are not currently enrolled as MD or PA students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (17)

  • Society, A.C. Melanoma Skin Cancer. 2016.

    BACKGROUND
  • 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: 22469345BACKGROUND
  • 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: 27645105BACKGROUND
  • 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: 19189902BACKGROUND
  • Society, A.C. Skin Exams. 2016.

    BACKGROUND
  • 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: 9693179BACKGROUND
  • 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: 18209169BACKGROUND
  • Herschorn A. Dermoscopy for melanoma detection in family practice. Can Fam Physician. 2012 Jul;58(7):740-5, e372-8.

    PMID: 22859635BACKGROUND
  • 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: 11369910BACKGROUND
  • 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: 7804996BACKGROUND
  • 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: 3958271BACKGROUND
  • 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: 21242390BACKGROUND
  • 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: 24220723BACKGROUND
  • 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: 28329558BACKGROUND
  • 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: 24204061BACKGROUND
  • 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: 23552462BACKGROUND
  • Brooke, J., SUS: A

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 11, 2017

Study Start

August 10, 2017

Primary Completion

February 6, 2018

Study Completion

February 6, 2018

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations