Using MC1R Genotype to Impact Melanoma Risk Behavior

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: Completed
• Conditions: Skin Cancer; Melanoma (Skin); Basal Cell Carcinoma; Squamous Cell Carcinoma; Squamous Cell Cancer; Basal Cell Cancer
• Intervention / Treatment: Behavioral: Personalized Information; Other: DNA Extraction Determination of MC1R Genotypes; Behavioral: Standard Information

• Study Type: Interventional
• Enrollment (Actual): 2054
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Weekday Sun Exposure - NHW - Baseline	Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population	Baseline
Weekday Sun Exposure - NHW - After Intervention	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	Self-reported average hours spent outside during weekends for the Non-Hispanic White Population	Baseline
Weekend Sun Exposure - NHW - After Intervention	Self-reported average hours spent outside during weekends for the Non-Hispanic White Population after receiving the intervention	12 Months
Sunburns - NHW - Baseline	Self-reported number of red or painful sunburns for the Non-Hispanic White Population	Baseline
Sunburns - NHW - After Intervention	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	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	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	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	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	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	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	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	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	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	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	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	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	Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population	Baseline
Participants With Indoor Intentional Tanning - NHW - After Intervention	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	Self-reported number of hours of weekday sun exposure for the Hispanic Population	Baseline
Weekday Sun Exposure - Hispanic Population After Intervention	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	Self-reported number of hours of weekend sun exposure for the Hispanic Population	Baseline
Weekend Sun Exposure - Hispanic Population - After Intervention	Self-reported number of hours of weekend sun exposure for the Hispanic Population after receiving the intervention	9 Months
Sunburns - Hispanic Population - Baseline	Self-reported number of Sunburns for the Hispanic Population	Baseline
Sunburns - Hispanic Population - After Intervention	Self-reported number of Sunburns for the Hispanic Population after receiving the intervention	9 Months
Outdoor Intentional Tanning - Hispanic Population - 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	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	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	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	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	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	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	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	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	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	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	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	Participants with at least one indoor intentional tanning session for the Hispanic Population	Baseline
Participants With Intentional Indoor Tanning - Hispanic Population - After Intervention	Participants with at least one indoor intentional tanning session for the Hispanic Population after receiving the intervention	9 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekday Sun Exposure - NHW Children - 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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Self-reported number of Sunburns among the children of the participants in the Hispanic Population	Baseline
Sunburns - Hispanic Children Population - After Intervention	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	Children of participants in the Hispanic Population who wore a hat before receiving the intervention	Baseline
Wearing a Hat - Hispanic Children Population - After Intervention	Children of participants in the Hispanic Population who wore a hat after receiving the intervention	9 months
Seeking Shade - Hispanic Children Population - 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	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	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	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	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	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	Children of the participants in the Hispanic Population who reported wearing sunglasses	Baseline
Wearing Sunglasses - Hispanic Children Population - After Intervention	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	Children of the participants in the Hispanic Average Risk Population wo reported wearing sunscreen	Baseline
Wearing Sunscreen - Hispanic Children Population - After Intervention	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	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	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

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: University of South Florida; American Cancer Society, Inc.; The Ponce Health Sciences University
• Investigators: Principal Investigator: Peter Kanetsky, Ph.D, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

General Publications

• Lacson JCA, Forgas SM, Doyle SH, Qian L, Del Rio J, Valavanis S, Carvajal R, Gonzalez-Calderon G, Kim Y, Roetzheim RG, Vadaparampil ST, Kanetsky PA. Assessment of melanoma precision prevention materials incorporating MC1R genetic risk information. Transl Behav Med. 2022 May 26;12(5):683-687. doi: 10.1093/tbm/ibac034.

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2015
• Primary Completion (Actual): February 19, 2021
• Study Completion (Actual): February 19, 2021

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: questionnaire; educational materials; skin cancer prevention; skin cancer risk; MC1R genotype
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Carcinoma; Melanoma; Carcinoma, Squamous Cell; Skin Neoplasms; Neoplasms, Squamous Cell; Carcinoma, Basal Cell; Neoplasms, Basal Cell
• Other Study ID 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