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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069104
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Nicholas Carcioppolo, University of Miami

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

Condition or disease Intervention/treatment
Diagnoses Disease Behavioral: ABCD Information Behavioral: UDS information Behavioral: Standard (clinical) feedback Behavioral: Motivational feedback

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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: UDS information
The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.

Behavioral: Standard (clinical) feedback
Feedback on mole identification task provided by a dermatologist.

UDS method training with motivational feedback
UDS message intervention with dermatological feedback and a motivational message.
Behavioral: UDS information
The intervention condition includes exposure to a message emphasizing the UDS 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.

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 and UDS trainings with standard feedback
Both message interventions with dermatological 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.

Behavioral: Standard (clinical) feedback
Feedback on mole identification task provided by a dermatologist.

ABCD and UDS trainings with motivational feedback
Both message interventions 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: UDS information
The intervention condition includes exposure to a message emphasizing the UDS 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 and UDS trainings with no feedback
Both message interventions 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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults living in U.S. who are members of the online panel.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069104


Contacts
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Contact: Nicholas Carcioppolo, PhD 305-284-5633 n.carcioppolo@Miami.edu

Locations
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United States, Florida
University of Miami
Coral Gables, Florida, United States, 33146
Contact: Nicholas Carcioppolo, PhD    305-284-5633    n.carcioppolo@miami.edu   
Principal Investigator: Nicholas Carcioppolo, PhD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Nicholas Carcioppolo, PhD Study Co-Principal Investigator
Principal Investigator: Soyoon Kim, PhD Study Co-Principal Investigator
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Responsible Party: Nicholas Carcioppolo, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04069104    
Other Study ID Numbers: 20190153
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nicholas Carcioppolo, University of Miami:
Melanoma identification
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas