Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Melanoma

Carcinoma, Basal Cell

Skin Neoplasms

Neoplasms, Squamous Cell

Neoplasms, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

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.

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.

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.

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.

Personalized information about ways that participants can protect themselves and their child from developing melanoma.

Personalized Information

Standard information about ways that participants can protect themselves and their child from developing melanoma.

Standard Information

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.

DNA Extraction Determination of MC1R Genotypes

Peter Kanetsky, Ph.D

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.

Using MC1R Genotype to Impact Melanoma Risk Behavior

Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population

Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population after they received the intervention

Self-reported average hours spent outside during weekends for the Non-Hispanic White Population

Self-reported average hours spent outside during weekends for the Non-Hispanic White Population after receiving the intervention

Self-reported number of red or painful sunburns for the Non-Hispanic White Population

Self-reported number of red or painful sunburns for the Non-Hispanic White Population after receiving the intervention

Self-reported number on a scale from 1=never to 5=always for outdoor intentional tanning for the Non-Hispanic White Population

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population

Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population after receiving the intervention

Self-reported number of hours of weekday sun exposure for the Hispanic Population

Self-reported number of hours of weekday sun exposure of the Hispanic population after receiving the intervention

Self-reported number of hours of weekend sun exposure for the Hispanic Population

Self-reported number of hours of weekend sun exposure for the Hispanic Population after receiving the intervention

Self-reported number of Sunburns for the Hispanic Population

Self-reported number of Sunburns for the Hispanic Population after receiving the intervention

Self-reported number on a scale from 1=never to 5=always intentional tanning for the Hispanic Population

Self-reported number on a scale from 1=never to 5=always outdoor intentional tanning for the Hispanic Population after receiving the intervention

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Participants with at least one indoor intentional tanning session for the Hispanic Population

Participants with at least one indoor intentional tanning session for the Hispanic Population after receiving the intervention

Self-reported average hours spent outside during weekdays among the children of the participants in the Non-Hispanic White Population

Self-reported average hours spent outside during weekends among the children of the participants in the Non-Hispanic White Population

Self-reported number of red or painful sunburns among the children of the participants in the Non-Hispanic White Population

Self-reported number of red or painful sunburns among the children of the participants in the Non-Hispanic White Population after receiving the intervention

Self-reported number of hours for outdoor intentional tanning among the children of the participants in the Non-Hispanic White Population

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

Self-reported number of hours for wearing a hat outdoors among the children of the participants in the Non-Hispanic White Population

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

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

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

Average Risk Participants children who wore a shirt with sleeves outdoors among the participants in the Non-Hispanic White Population

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

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

Self-reported number of hours for wearing sunglasses outdoors among the children of the participants in the Non-Hispanic White Average Risk Population

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

Children of the participants in the Non-Hispanic White High Risk Population who wore sunglasses outdoors

Children of the participants in the Non-Hispanic White High Risk Population who wore sunglasses outdoors after receiving the intervention

Self-reported number of hours for wearing sunscreen outdoors among the children of the participants in the Non-Hispanic White Population

Self-reported number of hours wearing sunscreen outdoors among the children of the participants in the Non-Hispanic White Population after receiving the intervention

Self-reported number of hours of weekday sun exposure among the children of the participants in the Hispanic Population

Self-reported number of hours of weekday sun exposure among the children of the participants in the Hispanic Population after receiving the intervention

Self-reported number of hours of weekend sun exposure among the children of the participants in the Hispanic Population

Self-reported number of hours of weekend sun exposure among the children of the participants in the Hispanic Population after receiving the intervention

Self-reported number of hours of sun protection behaviors among the children of the participants in the Hispanic Population

Self-reported number of hours of sun protection behaviors among the children of the participants in the Hispanic Population after receiving the intervention

Self-reported number of hours of outdoor intentional tanning among the children of the participants in the Hispanic Population

Self-reported number of hours of outdoor intentional tanning among the children of the participants in the Hispanic Population after receiving the intervention

Self-reported number of Sunburns among the children of the participants in the Hispanic Population

Self-reported number of Sunburns among the children of the participants in the Hispanic Population after receiving the intervention

Children of participants in the Hispanic Population who wore a hat before receiving the intervention

Children of participants in the Hispanic Population who wore a hat after receiving the intervention

Self-reported number of hours of seeking shade or using an umbrella among the children of the participants in the Hispanic Population

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

Children of the participants in the Hispanic Average Risk Population who reported wearing a shirt with sleeves outdoors

Children of the participants in the Hispanic Average Risk Population who reported wearing a shirt with sleeves outdoors, after receiving the intervention

Self-reported number of hours of wearing a shirt among the children of the participants in the Hispanic Population

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

Children of the participants in the Hispanic Population who reported wearing sunglasses

Children of the participants in the Hispanic Population who reported wearing sunglasses, after receiving the intervention

Children of the participants in the Hispanic Average Risk Population wo reported wearing sunscreen

Children of the participants in the Hispanic Average Risk Population wo reported wearing sunscreen, after receiving the intervention

Self-reported number of hours of wearing sunscreen among the children of the participants in the Hispanic High Risk Population

Self-reported number of hours of wearing sunscreen among the children of the participants in the Hispanic High Risk Population after receiving the intervention

The Ponce Health Sciences University

University of South Florida

American Cancer Society, Inc.

H. Lee Moffitt Cancer Center and Research Institute

Post determination of MC1R Genotypes, participants in the average risk standard arm (control) received mailed materials containing information on (1) melanoma and skin cancer; and (2) melanoma prevention behaviors recommended by the American Academy of Dermatology. All participants received information on sun protection behaviors targeted at children.

MC1R Average Risk- Control- Non-Hispanic White Population

Participants in the average risk precision prevention arm (intervention) received mailed materials containing information on: (1) melanoma and skin cancer; (2) genetic risk for melanoma; (3) MC1R and its role in developing melanoma, their MC1R risk group, and interpretation of risk information; and (4) melanoma prevention behaviors in the context of genetic risk.

MC1R Average Risk - Intervention- Non-Hispanic White Population

Post determination of MC1R Genotypes, participants in the higher risk standard arm (control) received mailed materials containing information on (1) melanoma and skin cancer; and (2) melanoma prevention behaviors recommended by the American Academy of Dermatology. All participants received information on sun protection behaviors targeted at children.

MC1R Higher Risk- Control - Non-Hispanic White Population

Participants in the higher risk precision prevention arm (intervention) received mailed materials containing information on: (1) melanoma and skin cancer; (2) genetic risk for melanoma; (3) MC1R and its role in developing melanoma, their MC1R risk group, and interpretation of risk information; and (4) melanoma prevention behaviors in the context of genetic risk.

MC1R Higher Risk - Intervention- Non-Hispanic White Population

Post determination of MC1R Genotypes, participants in the average risk standard arm (Control) received mailed materials containing information on (1) melanoma and skin cancer; and (2) melanoma prevention behaviors recommended by the American Academy of Dermatology. All participants received information on sun protection behaviors targeted at children.

MC1R Average Risk- Control- Hispanic Population

Participants in the average risk precision prevention arm (Intervention) received mailed materials containing information on: (1) melanoma and skin cancer; (2) genetic risk for melanoma; (3) MC1R and its role in developing melanoma, their MC1R risk group, and interpretation of risk information; and (4) melanoma prevention behaviors in the context of genetic risk.

MC1R Average Risk - Intervention- Hispanic Population

Post determination of MC1R Genotypes, participants in the higher risk standard arm (Control) received mailed materials containing information on (1) melanoma and skin cancer; and (2) melanoma prevention behaviors recommended by the American Academy of Dermatology. All participants received information on sun protection behaviors targeted at children.

MC1R Higher Risk- Control - Hispanic Population

MC1R Higher Risk - Intervention- Hispanic Population

Total

Age <=18 years

Between 18 and 65 years

> =65 years

Unknown

Age, Customized

Male

Female

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Puerto Rico

United States

Region of Enrollment

Participants with at least one child ages 10 years of age or younger completed additional questions about the child's primary prevention activities

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using MC1R Genotype to Impact Melanoma Risk Behavior	NCT03509467	Melanoma (Skin) Squamous Cell C... Squamous Cell C... Skin Cancer Basal Cell Carc... Basal Cell Canc...	Personalized In... Standard Inform... DNA Extraction ...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Using MC1R Genotype to Impact Melanoma Risk Behavior	NCT03509467	Melanoma (Skin) Squamous Cell C... Squamous Cell C... Skin Cancer Basal Cell Carc... Basal Cell Canc...	Personalized In... Standard Inform... DNA Extraction ...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Using MC1R Genotype to Impact Melanoma Risk Behavior	NCT03509467	Melanoma (Skin) Squamous Cell C... Squamous Cell C... Skin Cancer Basal Cell Carc... Basal Cell Canc...	Personalized In... Standard Inform... DNA Extraction ...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

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