Lesion; PigmentNCT03246633
Perceptual Expertise Training for Triage of Moles
A study testing Perceptual Training in people with Lesion; Pigment and Diagnostic Self Evaluation, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lesion; Pigment, Diagnostic Self Evaluation
- What is being tested?
- Perceptual Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2017to 6 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Perceptual Training to Improve Early Detection of Melanoma by Future Healthcare Providers: to Accuarate Triage of Benign vs. Malignant Pigmented Skin Lesions
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.
Read the detailed description
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.
- Conditions
- Lesion; Pigment, Diagnostic Self Evaluation
- Being tested
- Perceptual Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptual TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Perceptual Training | Other | Single-Arm study, all participants will receive educational training via online modules and will be assessed after completion of the training. Receives: Other: Perceptual Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (1)
Effectiveness of Course
Effectiveness of the course will be assessed with quiz requiring a benign or malignant decision about each image presents
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start10 Aug 2017
- Primary completion6 Feb 2018
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Lesion; PigmentStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Robinson, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246633
- Sponsor's protocol ID
- STU00205548
- Status last verified
- Sep 2018
- First submitted
- 28 Jul 2017
- Last updated
- 25 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Society, A.C. Melanoma Skin Cancer. 2016.
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.
PubMed 22469345Aviles-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.
PubMed 27645105Summaries 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.
PubMed 19189902Society, A.C. Skin Exams. 2016.
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.
PubMed 9693179Scope 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.
PubMed 18209169Herschorn A. Dermoscopy for melanoma detection in family practice. Can Fam Physician. 2012 Jul;58(7):740-5, e372-8.
PubMed 22859635Brochez 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.
PubMed 11369910Wender 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.
PubMed 7804996Cassileth 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.
PubMed 3958271Oliveria 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.
PubMed 21242390Garg 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.
PubMed 24220723Lofgreen 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.
PubMed 28329558Eide 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.
PubMed 24204061
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptual Training to Improve Early Detection of Melanoma by Future Healthcare Providers: to Accuarate Triage of Benign vs. Malignant Pigmented Skin Lesions
- ClinicalTrials.gov ID
- NCT03246633
- Acronym / sponsor ID
- STU00205548
- Conditions
- Lesion; Pigment, Diagnostic Self Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perceptual Training | Other | Other: Perceptual TrainingSingle-Arm study, all participants will receive educational training via online modules and will be assessed after completion of the training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- be over the age of 18
- be currently enrolled in an MD or PA course at Northwestern University Feinberg School of Medicine
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perceptual TrainingParticipants 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. | Other | Perceptual Training |
Primary outcome
Usability of Course
Time frame: 18 months
Usability will be assessed with the System Usability Scale, a widely accepted and validated scale to assess consumer satisfaction with new products
1 secondary outcome
Effectiveness of Course
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- BackgroundSociety, A.C. Melanoma Skin Cancer. 2016.
- Background: PubMed 22469345Reed 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.
- Background: PubMed 27645105Aviles-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.
- Background: PubMed 19189902Summaries 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.
- BackgroundSociety, A.C. Skin Exams. 2016.
- Background: PubMed 9693179Thomas 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.
- Background: PubMed 18209169Scope 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.
- Background: PubMed 22859635Herschorn A. Dermoscopy for melanoma detection in family practice. Can Fam Physician. 2012 Jul;58(7):740-5, e372-8.
- Background: PubMed 11369910Brochez 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.
- Background: PubMed 7804996Wender 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.
- Background: PubMed 3958271Cassileth 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.
- Background: PubMed 21242390Oliveria 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceptual Training in people with Lesion; Pigment and Diagnostic Self Evaluation, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of Course (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246633, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.