- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04069104
Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification
October 15, 2021 updated by: Nicholas Carcioppolo, University of Miami
The purpose of this study is to evaluate an interactive game designed to increase people's ability to identify cancerous moles.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1849
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
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- University of Miami
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults living in U.S. who are members of the online panel.
Description
Inclusion Criteria:
- Resident of U.S.
- At least 18 years old
- Capable of reading English
- Member of panel assembled by survey provider
Exclusion Criteria:
- Individuals under 18 years old
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
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ABCD training with standard feedback
Asymmetry, Border, Color, Diameter (ABCD) training message intervention with standard dermatological feedback
|
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
Feedback on mole identification task provided by a dermatologist.
|
ABCD training with motivational feedback
ABCD training message intervention with dermatological feedback and a motivational message
|
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
Feedback on mole identification task provided by a dermatologist plus exposure to a motivational fear appeal message designed to increase skin self exam intentions.
|
ABCD training with no feedback
ABCD message intervention with no feedback
|
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
|
UDS method training with standard feedback
Ugly Duckling Sign (UDS) method message intervention with dermatological feedback.
|
Feedback on mole identification task provided by a dermatologist.
The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.
|
UDS method training with motivational feedback
UDS message intervention with dermatological feedback and a motivational message.
|
Feedback on mole identification task provided by a dermatologist plus exposure to a motivational fear appeal message designed to increase skin self exam intentions.
The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.
|
UDS training with no feedback
UDS message intervention with no feedback.
|
The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.
|
ABCD-F training with standard feedback
ABCD-F intervention with dermatological feedback.
|
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
Feedback on mole identification task provided by a dermatologist.
The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.
|
ABCD-F training with motivational feedback
ABCD-F intervention with dermatological feedback and a motivational message.
|
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
Feedback on mole identification task provided by a dermatologist plus exposure to a motivational fear appeal message designed to increase skin self exam intentions.
The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.
|
ABCD-F training with no feedback
ABCD-F intervention with no feedback.
|
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.
|
No message intervention with standard feedback
No message intervention, but with dermatological feedback.
|
Feedback on mole identification task provided by a dermatologist.
|
No message intervention with motivational feedback
No message intervention, but with dermatological feedback and a motivational message.
|
Feedback on mole identification task provided by a dermatologist plus exposure to a motivational fear appeal message designed to increase skin self exam intentions.
|
No message intervention with no feedback
No message intervention and no feedback.
True control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mole identification accuracy
Time Frame: Day 2
|
Mole identification accuracy will be reported as the amount of mole correctly identified as either melanoma or typical nevi
|
Day 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin Self Exam Intentions
Time Frame: Day 2
|
Self-report measure of intentions to perform a skin self exam.
Quantified using a single item indicator with scores ranging from 1-7 with higher scores indicating greater intentions to perform a skin self exam to detect potential melanomas.
|
Day 2
|
Intentions to see a Dermatologist
Time Frame: Day 2
|
Self-report measure of intentions to schedule an appointment with a dermatologist to receive a skin cancer exam.
Quantified using a single item indicator with scores ranging from 1-7 with higher scores indicating greater intentions to schedule an appointment with a dermatologist.
|
Day 2
|
Skin Self Exam Attitudes
Time Frame: Day 2
|
Self-report measure of attitudes towards skin cancer exams.
Quantified using the mean of the self report scale with scores ranging from 1-7 with higher scores indicating more positive attitudes towards skin self exams.
|
Day 2
|
Skin Self Exam Beliefs
Time Frame: Day 2
|
Self-report measure of beliefs towards skin cancer exams.
Quantified using the mean of the self report scales for perceived susceptibility, perceived severity, perceived self-efficacy, and perceived response efficacy with scores ranging from 1-7 with higher scores indicating more strongly held beliefs about skin self exams.
|
Day 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nicholas Carcioppolo, PhD, Study Co-Principal Investigator
- Principal Investigator: Soyoon Kim, PhD, Study Co-Principal Investigator
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 (Actual)
November 13, 2020
Primary Completion (Actual)
March 3, 2021
Study Completion (Actual)
March 3, 2021
Study Registration Dates
First Submitted
August 23, 2019
First Submitted That Met QC Criteria
August 23, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
October 25, 2021
Last Update Submitted That Met QC Criteria
October 15, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20190153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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