Diagnoses DiseaseNCT04069104

Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification

An observational study of Diagnoses Disease, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate an interactive game designed to increase people's ability to identify cancerous moles. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diagnoses Disease
What is being tested?: ABCD Information, UDS information and Standard (clinical) feedback
Type of treatment: Lifestyle or therapy programme
How many people: 1,849 participants
Where: 1 siteUnited States
Study dates: 13 Nov 2020to 3 Mar 2021
Phase: Observational
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

Study population: Adults living in U.S. who are members of the online panel.

Who may be able to join

Resident of U.S.
At least 18 years old
Capable of reading English
Member of panel assembled by survey provider

Who cannot join

Individuals under 18 years old

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Coral Gables, Florida, 33146

Other trials in United States

About this study

The purpose of this study is to evaluate an interactive game designed to increase people's ability to identify cancerous moles.

Conditions: Diagnoses Disease
Being tested: ABCD Information, UDS information, Standard (clinical) feedback, Motivational feedback
Keywords: Melanoma identification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABCD InformationBehavioural
The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
UDS informationBehavioural
The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.
Standard (clinical) feedbackBehavioural
Feedback on mole identification task provided by a dermatologist.
Motivational feedbackBehavioural
Feedback on mole identification task provided by a dermatologist plus exposure to a motivational fear appeal message designed to increase skin self exam intentions.

Study groups in NCT04069104
Study group	Role	What they receive
ABCD training with standard feedback		Asymmetry, Border, Color, Diameter (ABCD) training message intervention with standard dermatological feedback Receives: Behavioral: ABCD Information; Behavioral: Standard (clinical) feedback
ABCD training with motivational feedback		ABCD training message intervention with dermatological feedback and a motivational message Receives: Behavioral: ABCD Information; Behavioral: Motivational feedback
ABCD training with no feedback		ABCD message intervention with no feedback Receives: Behavioral: ABCD Information
UDS method training with standard feedback		Ugly Duckling Sign (UDS) method message intervention with dermatological feedback. Receives: Behavioral: UDS information; Behavioral: Standard (clinical) feedback
UDS method training with motivational feedback		UDS message intervention with dermatological feedback and a motivational message. Receives: Behavioral: UDS information; Behavioral: Motivational feedback
UDS training with no feedback		UDS message intervention with no feedback. Receives: Behavioral: UDS information
ABCD-F training with standard feedback		ABCD-F intervention with dermatological feedback. Receives: Behavioral: ABCD Information; Behavioral: UDS information; Behavioral: Standard (clinical) feedback
ABCD-F training with motivational feedback		ABCD-F intervention with dermatological feedback and a motivational message. Receives: Behavioral: ABCD Information; Behavioral: UDS information; Behavioral: Motivational feedback
ABCD-F training with no feedback		ABCD-F intervention with no feedback. Receives: Behavioral: ABCD Information; Behavioral: UDS information
No message intervention with standard feedback		No message intervention, but with dermatological feedback. Receives: Behavioral: Standard (clinical) feedback
No message intervention with motivational feedback		No message intervention, but with dermatological feedback and a motivational message. Receives: Behavioral: Motivational feedback
No message intervention with no feedback		No message intervention and no feedback. True control.

What is being measured

The primary outcome is the main question the study is designed to answer.

Mole identification accuracy
Mole identification accuracy will be reported as the amount of mole correctly identified as either melanoma or typical nevi
Measured: Day 2

Secondary outcomes (4)

Skin Self Exam Intentions
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.
Measured: Day 2
Intentions to see a Dermatologist
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.
Measured: Day 2
Skin Self Exam Attitudes
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.
Measured: Day 2
Skin Self Exam Beliefs
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.
Measured: Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 20203 Mar 2021

First posted28 Aug 2019
Study start13 Nov 2020
Primary completion3 Mar 2021
Study completion3 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
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: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 1,849 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04069104
Sponsor's protocol ID: 20190153
Status last verified: Oct 2021
First submitted: 23 Aug 2019
Last updated: 25 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diagnoses Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification
ClinicalTrials.gov ID: NCT04069104
Acronym / sponsor ID: 20190153
Conditions: Diagnoses Disease
Keywords: Melanoma identification
Study type: Observational
Recruitment status: Completed
Enrolment: 1,849 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: 13 Nov 2020 (actual)
Primary completion: 3 Mar 2021 (actual)
Study completion: 3 Mar 2021 (actual)
First posted: 28 Aug 2019 (actual)
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 purpose of this study is to evaluate an interactive game designed to increase people's ability to identify cancerous moles.

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 12

Arm	Type	Receives
ABCD training with standard feedback	–	Behavioral: ABCD Information, Behavioral: Standard (clinical) feedbackAsymmetry, Border, Color, Diameter (ABCD) training message intervention with standard dermatological feedback
ABCD training with motivational feedback	–	Behavioral: ABCD Information, Behavioral: Motivational feedbackABCD training message intervention with dermatological feedback and a motivational message
ABCD training with no feedback	–	Behavioral: ABCD InformationABCD message intervention with no feedback
UDS method training with standard feedback	–	Behavioral: UDS information, Behavioral: Standard (clinical) feedbackUgly Duckling Sign (UDS) method message intervention with dermatological feedback.
UDS method training with motivational feedback	–	Behavioral: UDS information, Behavioral: Motivational feedbackUDS message intervention with dermatological feedback and a motivational message.
UDS training with no feedback	–	Behavioral: UDS informationUDS message intervention with no feedback.
ABCD-F training with standard feedback	–	Behavioral: ABCD Information, Behavioral: UDS information, Behavioral: Standard (clinical) feedbackABCD-F intervention with dermatological feedback.
ABCD-F training with motivational feedback	–	Behavioral: ABCD Information, Behavioral: UDS information, Behavioral: Motivational feedbackABCD-F intervention with dermatological feedback and a motivational message.
ABCD-F training with no feedback	–	Behavioral: ABCD Information, Behavioral: UDS informationABCD-F intervention with no feedback.
No message intervention with standard feedback	–	Behavioral: Standard (clinical) feedbackNo message intervention, but with dermatological feedback.
No message intervention with motivational feedback	–	Behavioral: Motivational feedbackNo message intervention, but with dermatological feedback and a motivational message.
No message intervention with no feedback	–	–No message intervention and no feedback. True control.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Adults living in U.S. who are members of the online panel.

Key inclusion criteria (4 listed)

Resident of U.S.
At least 18 years old
Capable of reading English
Member of panel assembled by survey provider

Key exclusion criteria (1 listed)

Individuals under 18 years old

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
ABCD InformationThe intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.	Behavioural	ABCD training with motivational feedback, ABCD training with no feedback, ABCD training with standard feedback, ABCD-F training with motivational feedback, ABCD-F training with no feedback, ABCD-F training with standard feedback
UDS informationThe intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.	Behavioural	ABCD-F training with motivational feedback, ABCD-F training with no feedback, ABCD-F training with standard feedback, UDS method training with motivational feedback, UDS method training with standard feedback, UDS training with no feedback
Standard (clinical) feedbackFeedback on mole identification task provided by a dermatologist.	Behavioural	ABCD training with standard feedback, ABCD-F training with standard feedback, No message intervention with standard feedback, UDS method training with standard feedback
Motivational feedbackFeedback on mole identification task provided by a dermatologist plus exposure to a motivational fear appeal message designed to increase skin self exam intentions.	Behavioural	ABCD training with motivational feedback, ABCD-F training with motivational feedback, No message intervention with motivational feedback, UDS method training with motivational feedback

Primary outcome

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

4 secondary outcomes

Skin Self Exam Intentions
Time frame: Day 2
Intentions to see a Dermatologist
Time frame: Day 2
Skin Self Exam Attitudes
Time frame: Day 2
Skin Self Exam Beliefs
Time frame: Day 2

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 25 Oct 2021.
Individual participant dataSharing planned: No

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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.

Nicholas Carcioppolo, PhD principal investigator

Study Co-Principal Investigator

Soyoon Kim, PhD principal investigator

Study Co-Principal Investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diagnoses Disease, run by University of Miami 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 4 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 25 Oct 2021. 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?

Mole identification accuracy (time frame: Day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04069104.

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 25 Oct 2021; AzTrials last refreshed its copy on 30 Oct 2026.