Melanoma Simulation Model With Smartphone Devices: Training Physicians for Early Detection of Melanoma

July 30, 2014 updated by: June Robinson, Northwestern University

Melanoma Simulation Model With Smartphone Devices: Training Physicians to Perform Opportunistic Surveillance for Early Detection of Melanoma

The specific aim of this study is to determine if interactive touchscreen-based learning with deliberate practice modules can enhance the retention of life-saving medical skills when incorporated into medical training curricula. We will analyze the retention and confidence of screening skills by comparing outcomes on pretest and posttest in each arm.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Age-adjusted melanoma incidence among Caucasians has risen from 7.5 to 21.9 cases per 100,000 representing an increase of nearly 200% over 30 years. In contrast to other cancers (i.e. colorectal, prostate, cervical), melanoma is detected by intentional visual skin inspection. Intentional screening is the deliberate visual inspection of all cutaneous surfaces. However, fewer than 30% of primary care physicians (PCPs) reported training in skin cancer during their medical education. Early detection of melanoma by PCPs cannot be expected to improve without addressing both the PCPs' lack of training and their low confidence in examination skills pertaining to pigmented lesion exams. A focused intervention is required to improve PCPs' early detection of melanoma and mitigate the near-term consequences of an aging US population.

Opportunistic surveillance requires skills in both unaided visual inspection of the skin and in dermoscopy of lesions. Dermoscopy-a hand-held magnifying device that assists with diagnosis-reduces the number of unnecessary biopsies and improves the clinical sensitivity of diagnosing melanoma. Studies show that Australian PCPs trained to use a "three-point checklist of dermoscopy," developed biopsy ratios of benign to malignant lesions of 8:1 in the general population, which is comparable to dermatologists using dermoscopy. In 2009, the American Academy of Family Physicians held their first dermoscopy course at their Annual Scientific Meeting, and there is continuing demand for similar courses. By making dermoscopy customary for PCPs, PCPs will be able to detect melanomas opportunistically and render care to the at-risk population of elderly for whom they provide care. Smart-touchscreen technologies can potentially provide a safe environment for medical trainees to learn procedural and screening skills that are rarely available opportunities in the clinic. As such, these technologies may lead to better health outcomes in future populations.

In this study, eighty 3rd year medical and thirty 1st year physician's assistant students participate in a visual screening and dermoscopy curriculum aimed at improving the retention rate of the learned clinical skills. After a didactic lecture on melanoma screening, participants are randomized to either a control or an experimental study arm for the clinical skills workshop. The control arm represents our previously published clinical skills training workshop (IRB STU 0002705) in which participants interact with a simulated patient model presenting with pigment lesions and review dermoscopy images on a projector screen. In the experimental arm, the projector-based learning approach is replaced with a handheld touchscreen device (smartphone) preloaded with interactive melanoma screening tutorial. The smartphone provides instant feedback and remediation of improper clinical management decisions. Across both groups, all learning content remains similar. Further deliberate practice questions provided to the control arm are standardized while the experimental arm's questions are individualized based on weaknesses determined in the smartphone software.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Dermatology

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for Evaluation of the smartphone-based dermoscopy prototype device:

  • Thirty 4th year medical students and 2nd year physician assistant (PA) students with previous experience with the Melanoma Simulation Model of the back (IRB STU00025072)

Inclusion Criteria for teaching and testing sessions with medical students and physician assistant students:

  • Eighty third-year medical students and thirty PA students

Exclusion Criteria:

  • Those not meeting the above inclusion criteria

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

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Control Study Arm
The control participants will first interact with the simulated melanoma back model to learn clinical unaided visual inspection skills and then view a passive image projected onto a screen for dermoscopy learning. Remediation of inappropriate clinical decisions will be carried out by the research coordinator and is based on predefined feedback consistent across both arms of the study. Along with the projected images, the coordinator will provide each control participant with worksheets for the clinical Asymmetry, Border, Color, Diameter (ABCD) and Dermoscopy 3-point check list. A copy of the completed worksheet will be made at the end of the workshop.
EXPERIMENTAL: smartphone
Each participant in the educational intervention arm will have access to a smartphone with a preloaded android software package. The smartphone software allows the participant to visualize a dermoscopic image of the pigmented lesion at the surface of the simulated melanoma model. Participants are given the freedom to navigate through the program via the smartphone to learn at their own pace with reinforcement of correct clinical management decisions and correction of weaknesses. The software content is limited to the dermoscopy information available to the positive control arm through the coordinator and the dermoscopic images projected onto the screen, thus a comparison of retention rates across both arms is possible.
Other: Smartphone
Our team of dermatologists and biomechanical engineers led by the PI developed a simulation skills training prototype device using a smartphone. Software was developed to teach dermoscopic evaluation of pigmented lesions using the "three-poin checklist of dermoscopy". The software used in the smartphone presentation of the educational intervention also provides a decision tree of clinical management options and best-practices feedback. No patients are involved in this research.
Other Names:
  • educational intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of medical student's abilities to select pigmented lesions for review with dermoscopy on pre-didactic lecture test, pre-skills workshop test, and post-educational intervention test
Time Frame: Two weeks post initial didactic education
Retention will be measured using the percent of correctly identified benign nevi, clinically suspicious lesions, and melanomas identified by unaided visual inspection and the percent of correctly identified "benign" or "refer" lesions on dermoscopy images. The biopsy ratio of benign to malignant lesions will be also be assessed to determine the sensitivity and specificity outcomes of both study arms. Other outcomes measured are the confidence with identifying melanoma, attitudes toward melanoma screening, and recall of screening rules by participants. The rates of retention in both study arms will be compared on pre-workshop test and the post-test to determine if simulation learning modules positively impact learning and retention of skin screening.
Two weeks post initial didactic education

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: June K Robinson, MD, Northwestern University Department of Dermatology

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00077615

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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