MelanomaNCT01859845
Melanoma Simulation Model With Smartphone Devices: Training Physicians for Early Detection of Melanoma
A study testing Smartphone in people with Melanoma, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- Smartphone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2014
- 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
None listed.
Who cannot join
- Those not meeting the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- Smartphone
- Keywords
- Melanoma, Opportunistic surveillance, Melanoma simulation model, Smartphone devices
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartphoneOther
Also called educational intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Study Arm | No intervention | 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. |
| smartphone | Experimental | 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. Receives: Other: Smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Two weeks post initial didactic education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Robinson, Northwestern University
- Investigators
- June K Robinson, MD, Principal investigator, Northwestern University Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859845
- Sponsor's protocol ID
- STU00077615
- Status last verified
- Jul 2014
- First submitted
- 20 May 2013
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Simulation Model With Smartphone Devices: Training Physicians to Perform Opportunistic Surveillance for Early Detection of Melanoma
- ClinicalTrials.gov ID
- NCT01859845
- Acronym / sponsor ID
- STU00077615
- Conditions
- Melanoma
- Keywords
- Melanoma, Opportunistic surveillance, Melanoma simulation model, Smartphone devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 May 2013 (estimated)
- 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 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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Study Arm | No intervention | –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. |
| smartphone | Experimental | Other: SmartphoneEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Those not meeting the above inclusion criteria
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 |
|---|---|---|
| SmartphoneAlso: educational interventionOur 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 | smartphone |
Primary outcome
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.
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 1 Aug 2014.
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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.
June K Robinson, MD principal investigator
Northwestern University Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone in people with Melanoma, 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 0 inclusion and 1 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 1 Aug 2014. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2014.