NCT04069104

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,849

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 13, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

August 23, 2019

Last Update Submit

October 15, 2021

Conditions

Keywords

Melanoma identification

Outcome Measures

Primary Outcomes (1)

  • Mole identification accuracy

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

    Day 2

Secondary Outcomes (4)

  • Skin Self Exam Intentions

    Day 2

  • Intentions to see a Dermatologist

    Day 2

  • Skin Self Exam Attitudes

    Day 2

  • Skin Self Exam Beliefs

    Day 2

Study Arms (12)

ABCD training with standard feedback

Asymmetry, Border, Color, Diameter (ABCD) training message intervention with standard dermatological feedback

Behavioral: ABCD InformationBehavioral: Standard (clinical) feedback

ABCD training with motivational feedback

ABCD training message intervention with dermatological feedback and a motivational message

Behavioral: ABCD InformationBehavioral: Motivational feedback

ABCD training with no feedback

ABCD message intervention with no feedback

Behavioral: ABCD Information

UDS method training with standard feedback

Ugly Duckling Sign (UDS) method message intervention with dermatological feedback.

Behavioral: UDS informationBehavioral: Standard (clinical) feedback

UDS method training with motivational feedback

UDS message intervention with dermatological feedback and a motivational message.

Behavioral: UDS informationBehavioral: Motivational feedback

UDS training with no feedback

UDS message intervention with no feedback.

Behavioral: UDS information

ABCD-F training with standard feedback

ABCD-F intervention with dermatological feedback.

Behavioral: ABCD InformationBehavioral: UDS informationBehavioral: Standard (clinical) feedback

ABCD-F training with motivational feedback

ABCD-F intervention with dermatological feedback and a motivational message.

Behavioral: ABCD InformationBehavioral: UDS informationBehavioral: Motivational feedback

ABCD-F training with no feedback

ABCD-F intervention with no feedback.

Behavioral: ABCD InformationBehavioral: UDS information

No message intervention with standard feedback

No message intervention, but with dermatological feedback.

Behavioral: Standard (clinical) feedback

No message intervention with motivational feedback

No message intervention, but with dermatological feedback and a motivational message.

Behavioral: Motivational feedback

No message intervention with no feedback

No message intervention and no feedback. True control.

Interventions

The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.

ABCD training with motivational feedbackABCD training with no feedbackABCD training with standard feedbackABCD-F training with motivational feedbackABCD-F training with no feedbackABCD-F training with standard feedback
UDS informationBEHAVIORAL

The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.

ABCD-F training with motivational feedbackABCD-F training with no feedbackABCD-F training with standard feedbackUDS method training with motivational feedbackUDS method training with standard feedbackUDS training with no feedback

Feedback on mole identification task provided by a dermatologist.

ABCD training with standard feedbackABCD-F training with standard feedbackNo message intervention with standard feedbackUDS method training with standard 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 motivational feedbackABCD-F training with motivational feedbackNo message intervention with motivational feedbackUDS method training with motivational feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Individuals under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Study Officials

  • Nicholas Carcioppolo, PhD

    Study Co-Principal Investigator

    PRINCIPAL INVESTIGATOR
  • Soyoon Kim, PhD

    Study Co-Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

November 13, 2020

Primary Completion

March 3, 2021

Study Completion

March 3, 2021

Last Updated

October 25, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations