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

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.

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.
Observational

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.
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

  • United States
    • 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

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
ABCD training with standard feedback
Asymmetry, Border, Color, Diameter (ABCD) training message intervention with standard dermatological feedback
Behavioral: ABCD Information
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
Behavioral: Standard (clinical) feedback
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
Behavioral: ABCD Information
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
Behavioral: Motivational feedback
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
Behavioral: ABCD Information
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.
Behavioral: Standard (clinical) feedback
Feedback on mole identification task provided by a dermatologist.
Behavioral: UDS information
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.
Behavioral: Motivational feedback
Feedback on mole identification task provided by a dermatologist plus exposure to a motivational fear appeal message designed to increase skin self exam intentions.
Behavioral: UDS information
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.
Behavioral: UDS information
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.
Behavioral: ABCD Information
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
Behavioral: Standard (clinical) feedback
Feedback on mole identification task provided by a dermatologist.
Behavioral: UDS information
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.
Behavioral: ABCD Information
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
Behavioral: Motivational feedback
Feedback on mole identification task provided by a dermatologist plus exposure to a motivational fear appeal message designed to increase skin self exam intentions.
Behavioral: UDS information
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.
Behavioral: ABCD Information
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
Behavioral: UDS information
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.
Behavioral: Standard (clinical) 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.
Behavioral: Motivational feedback
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

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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

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

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: 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)

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.
November 13, 2020

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.
March 3, 2021

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.
March 3, 2021

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).
August 23, 2019

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.
August 23, 2019

First Posted (Actual)

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.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

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.
October 25, 2021

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.
October 15, 2021

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.
October 1, 2021

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.
  • 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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