Using MC1R Genotype to Impact Melanoma Risk Behavior

December 4, 2025 updated by: H. Lee Moffitt Cancer Center and Research Institute
The purpose of this study is to examine how different messages about risk of melanoma can impact the way people protect themselves against developing these diseases.

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.
Interventional

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.
2054

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine
  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

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

Yes

Description

Inclusion Criteria:

CRITERIA FOR: NON-HISPANIC WHITE POPULATION

  • Investigators will recruit participants from the Family Medicine and General Internal Medicine clinics of the Morsani Center at the University of South Florida.
  • White, non-Hispanic patients who self-report a low phenotypic risk profile for development of melanoma and are able to read and speak English fluently.
  • 18 years of age or older
  • Capable of giving informed consent
  • Potential participants will be screened for eligibility based on responses to questions about skin phenotypes, early detection behaviors and past history of melanoma.
  • After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.

CRITERIA FOR: HISPANIC POPULATION

  • Investigators will recruit participants living in Tampa Bay and Puerto Rico as part of the U54 Ponce Health Sciences University-Moffitt Cancer Center (PHSU-MCC) Partnership. In Tampa Bay, participants will be recruited from the Family Medicine and General Internal Medicine clinics of the Morsani Center at the University of South Florida, and from the Suncoast Community Health Centers.
  • Patients who self-report as Hispanics and are able to read and speak either Spanish or English fluently.
  • 18 years of age or older
  • Capable of giving informed consent
  • Potential participants will be screened for eligibility based on responses to early detection behaviors and past history of melanoma.
  • After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.

Exclusion Criteria:

CRITERIA FOR: NON-HISPANIC WHITE POPULATION

  • Have had a skin examination within the past year.
  • Do not meet race/ethnicity criteria for their group
  • White, non-Hispanic group - participants reporting sun-sensitive phenotypes
  • A personal history of melanoma

CRITERIA FOR: HISPANIC POPULATION

  • Have had a skin examination within the past year.
  • Do not meet ethnicity criteria for their group
  • White, non-Hispanic group - participants reporting sun-sensitive phenotypes
  • Participants with a personal history of melanoma and/or more personal history of more than on squamous cell cancer (SCC) and/or Basal Cell Cancer (BCC)

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Intervention Group A

Intervention Group A: Non-Hispanic White Population

Post determination of MC1R Genotypes, participants randomized to the intervention group, will receive personalized information about ways that they can protect themselves and their child from developing melanoma.

By the end of the study, all participants will have had the opportunity to receive information about their inherited risk.
Behavioral: Personalized Information
Personalized information about ways that participants can protect themselves and their child from developing melanoma.
Other Names:
  • educational materials
Other: DNA Extraction Determination of MC1R Genotypes
After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.
Other Names:
  • risk factor
Experimental: Intervention Group B

Intervention Group B: Hispanic Population

Post determination of MC1R Genotypes, participants randomized to the intervention group, will receive personalized information about ways that they can protect themselves and their child from developing melanoma.

By the end of the study, all participants will have had the opportunity to receive information about their inherited risk.
Behavioral: Personalized Information
Personalized information about ways that participants can protect themselves and their child from developing melanoma.
Other Names:
  • educational materials
Other: DNA Extraction Determination of MC1R Genotypes
After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.
Other Names:
  • risk factor
Placebo Comparator: Control Group A

Control Group A: Non-Hispanic White Population

Post determination of MC1R Genotypes, participants randomized to the control group, you will receive standard information about ways that they can protect themselves and their child from developing melanoma.

By the end of the study, all participants will have had the opportunity to receive information about their inherited risk. Participants randomized into the control group, by the end of the study will also have had the opportunity to receive personalized information about ways they can protect themselves and their child from developing melanoma.
Other: DNA Extraction Determination of MC1R Genotypes
After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.
Other Names:
  • risk factor
Behavioral: Standard Information
Standard information about ways that participants can protect themselves and their child from developing melanoma.
Other Names:
  • educational materials
Placebo Comparator: Control Group B

Control Group B: Hispanic Population

Post determination of MC1R Genotypes, participants randomized to the control group, you will receive standard information about ways that they can protect themselves and their child from developing melanoma.

By the end of the study, all participants will have had the opportunity to receive information about their inherited risk. Participants randomized into the control group, by the end of the study will also have had the opportunity to receive personalized information about ways they can protect themselves and their child from developing melanoma.
Other: DNA Extraction Determination of MC1R Genotypes
After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.
Other Names:
  • risk factor
Behavioral: Standard Information
Standard information about ways that participants can protect themselves and their child from developing melanoma.
Other Names:
  • educational materials

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
Weekday Sun Exposure - NHW - Baseline
Time Frame: Baseline
Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population
Baseline
Weekday Sun Exposure - NHW - After Intervention
Time Frame: 12 months
Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population after they received the intervention
12 months
Weekend Sun Exposure - NHW - Baseline
Time Frame: Baseline
Self-reported average hours spent outside during weekends for the Non-Hispanic White Population
Baseline
Weekend Sun Exposure - NHW - After Intervention
Time Frame: 12 Months
Self-reported average hours spent outside during weekends for the Non-Hispanic White Population after receiving the intervention
12 Months
Sunburns - NHW - Baseline
Time Frame: Baseline
Self-reported number of red or painful sunburns for the Non-Hispanic White Population
Baseline
Sunburns - NHW - After Intervention
Time Frame: 12 Months
Self-reported number of red or painful sunburns for the Non-Hispanic White Population after receiving the intervention
12 Months
Outdoor Intentional Tanning - NHW - Baseline
Time Frame: Baseline
Self-reported number on a scale from 1=never to 5=always for outdoor intentional tanning for the Non-Hispanic White Population
Baseline
Outdoor Intentional Tanning - NHW - After Intervention
Time Frame: 12 Months
Self-reported number on a scale from 1=never to 5=always outdoor intentional tanning for the Non-Hispanic White Population after receiving the intervention
12 Months
Proportion of Participants Wearing a Hat - NHW - Baseline
Time Frame: Baseline
Proportion who practiced wearing a hat for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Baseline
Proportion of Participants Wearing a Hat - NHW - After Intervention
Time Frame: 12 Months
Proportion who practiced wearing a hat for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
12 Months
Seeking Shade - NHW - Baseline
Time Frame: Baseline
Self-reported number of hours for seeking shade or using an umbrella outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Baseline
Seeking Shade - NHW - After Intervention
Time Frame: 12 Months
Self-reported number of hours for seeking shade or using an umbrella outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
12 Months
Wearing a Shirt - NHW - Baseline
Time Frame: Baseline
Self-reported number of hours for wearing a shirt with sleeves outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Baseline
Wearing a Shirt - NHW - After Intervention
Time Frame: 12 Months
Self-reported number of hours wearing a shirt with sleeves outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
12 Months
Wearing Sunglasses - NHW - Baseline
Time Frame: Baseline
Self-reported number of hours for wearing sunglasses outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Baseline
Wearing Sunglasses - NHW - After Intervention
Time Frame: 12 Months
Self-reported number of hours wearing sunglasses outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
12 Months
Wearing Sunscreen - NHW - Baseline
Time Frame: Baseline
Self-reported number of hours for wearing sunscreen outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Baseline
Wearing Sunscreen - NHW - After Intervention
Time Frame: 12 Months
Self-reported number of hours wearing sunscreen outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
12 Months
Participants With Indoor Intentional Tanning - NHW - Baseline
Time Frame: Baseline
Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population
Baseline
Participants With Indoor Intentional Tanning - NHW - After Intervention
Time Frame: 12 Months
Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population after receiving the intervention
12 Months
Weekday Sun Exposure - Hispanic Population Baseline
Time Frame: Baseline
Self-reported number of hours of weekday sun exposure for the Hispanic Population
Baseline
Weekday Sun Exposure - Hispanic Population After Intervention
Time Frame: 9 Months
Self-reported number of hours of weekday sun exposure of the Hispanic population after receiving the intervention
9 Months
Weekend Sun Exposure - Hispanic Population - Baseline
Time Frame: Baseline
Self-reported number of hours of weekend sun exposure for the Hispanic Population
Baseline
Weekend Sun Exposure - Hispanic Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of weekend sun exposure for the Hispanic Population after receiving the intervention
9 Months
Sunburns - Hispanic Population - Baseline
Time Frame: Baseline
Self-reported number of Sunburns for the Hispanic Population
Baseline
Sunburns - Hispanic Population - After Intervention
Time Frame: 9 Months
Self-reported number of Sunburns for the Hispanic Population after receiving the intervention
9 Months
Outdoor Intentional Tanning - Hispanic Population - Baseline
Time Frame: Baseline
Self-reported number on a scale from 1=never to 5=always intentional tanning for the Hispanic Population
Baseline
Outdoor Intentional Tanning - Hispanic Population - After Intervention
Time Frame: 9 Months
Self-reported number on a scale from 1=never to 5=always outdoor intentional tanning for the Hispanic Population after receiving the intervention
9 Months
Proportion of Participants Wearing a Hat - Hispanic Population - Baseline
Time Frame: Baseline
Proportion who practiced wearing a hat Often to Always for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Baseline
Proportion of Participants Wearing a Hat - Hispanic Population - After Intervention
Time Frame: 9 months
Proportion who practiced wearing a hat Often to Always for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
9 months
Seeking Shade - Hispanic Population - Baseline
Time Frame: Baseline
Self-reported number of hours of seeking shade or using an umbrella for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Baseline
Seeking Shade - Hispanic Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of seeking shade or using an umbrella for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
9 Months
Wearing a Shirt - Hispanic Population - Baseline
Time Frame: Baseline
Self-reported number of hours of wearing a shirt for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Baseline
Wearing a Shirt - Hispanic Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of wearing a shirt with sleeves outdoors for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
9 Months
Wearing Sunglasses - Hispanic Population - Baseline
Time Frame: Baseline
Self-reported number of hours of wearing sunglasses for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Baseline
Wearing Sunglasses - Hispanic Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of wearing sunglasses for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
9 Months
Wearing Sunscreen - Hispanic Population - Baseline
Time Frame: Baseline
Self-reported number of hours of wearing sunscreen for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Baseline
Wearing Sunscreen - Hispanic Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of wearing sunscreen for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
9 Months
Participants With Intentional Indoor Tanning - Hispanic Population - Baseline
Time Frame: Baseline
Participants with at least one indoor intentional tanning session for the Hispanic Population
Baseline
Participants With Intentional Indoor Tanning - Hispanic Population - After Intervention
Time Frame: 9 Months
Participants with at least one indoor intentional tanning session for the Hispanic Population after receiving the intervention
9 Months

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
Weekday Sun Exposure - NHW Children - Baseline
Time Frame: Baseline
Self-reported average hours spent outside during weekdays among the children of the participants in the Non-Hispanic White Population
Baseline
Weekday Sun Exposure - NHW Children - After Intervention
Time Frame: 12 months
Self-reported average hours spent outside during weekdays among the children of the participants in the Non-Hispanic White Population
12 months
Weekend Sun Exposure - NHW Children - Baseline
Time Frame: Baseline
Self-reported average hours spent outside during weekends among the children of the participants in the Non-Hispanic White Population
Baseline
Weekend Sun Exposure - NHW Children - After Intervention
Time Frame: 12 Months
Self-reported average hours spent outside during weekends among the children of the participants in the Non-Hispanic White Population
12 Months
Sunburns - NHW Children - Baseline
Time Frame: Baseline
Self-reported number of red or painful sunburns among the children of the participants in the Non-Hispanic White Population
Baseline
Sunburns - NHW Children - After Intervention
Time Frame: 12 Months
Self-reported number of red or painful sunburns among the children of the participants in the Non-Hispanic White Population after receiving the intervention
12 Months
Outdoor International Tanning - NHW Children - Baseline
Time Frame: Baseline
Self-reported number of hours for outdoor intentional tanning among the children of the participants in the Non-Hispanic White Population
Baseline
Outdoor Intentional Tanning - NHW Children - After Intervention
Time Frame: 12 Months
Self-reported number of hours for outdoor intentional tanning among the children of the participants in the Non-Hispanic White Population after receiving the intervention
12 Months
Wearing a Hat - NHW Children - Baseline
Time Frame: Baseline
Self-reported number of hours for wearing a hat outdoors among the children of the participants in the Non-Hispanic White Population
Baseline
Wearing a Hat - NHW Children - After Intervention
Time Frame: 12 Months
Self-reported number of hours for wearing a hat outdoors among the children of the participants in the Non-Hispanic White Population after receiving the intervention
12 Months
Seeking Shade - NHW Children - Baseline
Time Frame: Baseline
Self-reported number of hours for seeking shade or using an umbrella outdoors among the children of the participants in the Non-Hispanic White Population
Baseline
Seeking Shade - NHW Children - After Intervention
Time Frame: 12 Months
Self-reported number of hours for seeking shade or using an umbrella outdoors among the children of the participants in the Non-Hispanic White Population after receiving the intervention
12 Months
Wearing a Shirt - Average Risk NHW Children - Baseline
Time Frame: Baseline
Average Risk Participants children who wore a shirt with sleeves outdoors among the participants in the Non-Hispanic White Population
Baseline
Wearing a Shirt - Average Risk NHW Children - After Intervention
Time Frame: 12 Month
Average Risk Participants children who wore a shirt with sleeves outdoors among the participants in the Non-Hispanic White Population
12 Month
Wearing a Shirt - High Risk NHW Children - Baseline
Time Frame: 12 Months
Self-reported number of hours wearing a shirt with sleeves outdoors among the children of the participants in the Non-Hispanic White High Risk Population
12 Months
Wearing a Shirt - High Risk NHW Children - After Intervention
Time Frame: 12 Months
Self-reported number of hours wearing a shirt with sleeves outdoors among the children of the participants in the Non-Hispanic White High Risk Population after receiving the intervention
12 Months
Wearing Sunglasses - Average Risk NHW Children - Baseline
Time Frame: Baseline
Self-reported number of hours for wearing sunglasses outdoors among the children of the participants in the Non-Hispanic White Average Risk Population
Baseline
Wearing Sunglasses - Average Risk NHW Children - After Intervention
Time Frame: 12 Months
Self-reported number of hours wearing sunglasses outdoors among the children of the participants in the Non-Hispanic White Average Risk Population after receiving the intervention
12 Months
Wearing Sunglasses -High Risk NHW Children - Baseline
Time Frame: Baseline
Children of the participants in the Non-Hispanic White High Risk Population who wore sunglasses outdoors
Baseline
Wearing Sunglasses - High Risk NHW Children - After Intervention
Time Frame: 12 Months
Children of the participants in the Non-Hispanic White High Risk Population who wore sunglasses outdoors after receiving the intervention
12 Months
Wearing Sunscreen - NHW Children - Baseline
Time Frame: Baseline
Self-reported number of hours for wearing sunscreen outdoors among the children of the participants in the Non-Hispanic White Population
Baseline
Wearing Sunscreen - NHW Children - After Intervention
Time Frame: 12 Months
Self-reported number of hours wearing sunscreen outdoors among the children of the participants in the Non-Hispanic White Population after receiving the intervention
12 Months
Weekday Sun Exposure - Hispanic Children Population Baseline
Time Frame: Baseline
Self-reported number of hours of weekday sun exposure among the children of the participants in the Hispanic Population
Baseline
Weekday Sun Exposure - Hispanic Children Population After Intervention
Time Frame: 9 Months
Self-reported number of hours of weekday sun exposure among the children of the participants in the Hispanic Population after receiving the intervention
9 Months
Weekend Sun Exposure - Hispanic Children Population - Baseline
Time Frame: Baseline
Self-reported number of hours of weekend sun exposure among the children of the participants in the Hispanic Population
Baseline
Weekend Sun Exposure - Hispanic Children Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of weekend sun exposure among the children of the participants in the Hispanic Population after receiving the intervention
9 Months
Sun Protection Behaviors - Hispanic Children Population - Baseline
Time Frame: Baseline
Self-reported number of hours of sun protection behaviors among the children of the participants in the Hispanic Population
Baseline
Sun Protection Behaviors - Hispanic Children Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of sun protection behaviors among the children of the participants in the Hispanic Population after receiving the intervention
9 Months
Outdoor Intentional Tanning - Hispanic Children Population - Baseline
Time Frame: Baseline
Self-reported number of hours of outdoor intentional tanning among the children of the participants in the Hispanic Population
Baseline
Outdoor Intentional Tanning - Hispanic Children Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of outdoor intentional tanning among the children of the participants in the Hispanic Population after receiving the intervention
9 Months
Sunburns - Hispanic Children Population - Baseline
Time Frame: Baseline
Self-reported number of Sunburns among the children of the participants in the Hispanic Population
Baseline
Sunburns - Hispanic Children Population - After Intervention
Time Frame: 9 Months
Self-reported number of Sunburns among the children of the participants in the Hispanic Population after receiving the intervention
9 Months
Wearing a Hat - Hispanic Children Population - Baseline
Time Frame: Baseline
Children of participants in the Hispanic Population who wore a hat before receiving the intervention
Baseline
Wearing a Hat - Hispanic Children Population - After Intervention
Time Frame: 9 months
Children of participants in the Hispanic Population who wore a hat after receiving the intervention
9 months
Seeking Shade - Hispanic Children Population - Baseline
Time Frame: Baseline
Self-reported number of hours of seeking shade or using an umbrella among the children of the participants in the Hispanic Population
Baseline
Seeking Shade - Hispanic Children Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of seeking shade or using an umbrella among the children of the participants in the Hispanic Population after receiving the intervention
9 Months
Wearing a Shirt - Average Risk Hispanic Children Population - Baseline
Time Frame: Baseline
Children of the participants in the Hispanic Average Risk Population who reported wearing a shirt with sleeves outdoors
Baseline
Wearing a Shirt - Hispanic Children Population - After Intervention
Time Frame: 9 Months
Children of the participants in the Hispanic Average Risk Population who reported wearing a shirt with sleeves outdoors, after receiving the intervention
9 Months
Wearing a Shirt - Hispanic Children High Risk Population - Baseline
Time Frame: Baseline
Self-reported number of hours of wearing a shirt among the children of the participants in the Hispanic Population
Baseline
Wearing a Shirt - Hispanic Children High Risk Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of wearing a shirt with sleeves outdoors among the children of the participants in the Hispanic High Risk Population after receiving the intervention
9 Months
Wearing Sunglasses - Hispanic Children Population - Baseline
Time Frame: Baseline
Children of the participants in the Hispanic Population who reported wearing sunglasses
Baseline
Wearing Sunglasses - Hispanic Children Population - After Intervention
Time Frame: 9 Months
Children of the participants in the Hispanic Population who reported wearing sunglasses, after receiving the intervention
9 Months
Wearing Sunscreen - Hispanic Children Average Risk Population - Baseline
Time Frame: Baseline
Children of the participants in the Hispanic Average Risk Population wo reported wearing sunscreen
Baseline
Wearing Sunscreen - Hispanic Children Population - After Intervention
Time Frame: 9 Months
Children of the participants in the Hispanic Average Risk Population wo reported wearing sunscreen, after receiving the intervention
9 Months
Wearing Sunscreen - Hispanic Children High Risk Population - Baseline
Time Frame: Baseline
Self-reported number of hours of wearing sunscreen among the children of the participants in the Hispanic High Risk Population
Baseline
Wearing Sunscreen - Hispanic High Risk Children Population - After Intervention
Time Frame: 9 Months
Self-reported number of hours of wearing sunscreen among the children of the participants in the Hispanic High Risk Population after receiving the intervention
9 Months

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.
H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of South Florida
American Cancer Society, Inc.
Ponce Health Sciences University

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: Peter Kanetsky, Ph.D, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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.
August 3, 2015

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.
February 19, 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.
February 19, 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).
April 17, 2018

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.
April 17, 2018

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.
April 26, 2018

Study Record Updates

Last Update Posted (Estimated)

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.
December 19, 2025

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.
December 4, 2025

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.
December 1, 2025

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.
  • MCC-17984
  • MCC-19461 (Other Identifier: H. Lee Moffitt Cancer and Research Center)

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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Medical Conditions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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