- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01191294
Evaluation of a Simulation Training Tool to Identify Lesions Requiring Further Screening for Melanoma
September 24, 2014 updated by: June Robinson, Northwestern University
Development and Evaluation of a Simulation Training Module to Identify Lesions Requiring Further Visual Screen or Skin Biopsy for Melanoma
The investigators will design a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents.
This requires having a skin simulation model that presents a range of lesions from benign nevus to atypical nevus to melanoma in a distribution and density that mimics the clinical findings of those with 2 skin tones: fair-skin non- Hispanic white and Hispanic.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
270
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Medical student in his primary care clerkship at Northwestern University
Exclusion Criteria:
- Not a medical student in his primary care clerkship at Northwestern University
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Medical Students
3rd year medical students during their primary care clerkship
|
Simulation-based, mastery learning educational intervention in visual screening for melanoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simulation curriculum for screening for melanoma
Time Frame: 1 year
|
To design a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in melanoma detection skills
Time Frame: 1 hour
|
To measure changes in medical student and resident skills before and after the intervention, and determine if students achieve the zero error rate in recognizing the melanomas, namely no false negatives.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dennis P West, PhD, Northwestern University
- Principal Investigator: June Robinson, MD, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
August 27, 2010
First Submitted That Met QC Criteria
August 27, 2010
First Posted (Estimate)
August 30, 2010
Study Record Updates
Last Update Posted (Estimate)
September 25, 2014
Last Update Submitted That Met QC Criteria
September 24, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JKR-011510
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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