Personalized information
BehavioralPersonalized information about ways that participants can protect themselves and their child from developing melanoma.
Other names: educational materials
NCT Number: NCT03509467
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ponce School of Medicine, Ponce, Puerto Rico
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
CRITERIA FOR: NON-HISPANIC WHITE POPULATION
CRITERIA FOR: HISPANIC POPULATION
Exclusion criteria
CRITERIA FOR: NON-HISPANIC WHITE POPULATION
CRITERIA FOR: HISPANIC POPULATION
Personalized information about ways that participants can protect themselves and their child from developing melanoma.
Other names: educational materials
Standard information about ways that participants can protect themselves and their child from developing melanoma.
Other names: educational materials
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
Time frame: Baseline
Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population
Time frame: 12 months
Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population after they received the intervention
Time frame: Baseline
Self-reported average hours spent outside during weekends for the Non-Hispanic White Population
Time frame: 12 Months
Self-reported average hours spent outside during weekends for the Non-Hispanic White Population after receiving the intervention
Time frame: Baseline
Self-reported number of red or painful sunburns for the Non-Hispanic White Population
Time frame: 12 Months
Self-reported number of red or painful sunburns for the Non-Hispanic White Population after receiving the intervention
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline
Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population
Time frame: 12 Months
Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population after receiving the intervention
Time frame: Baseline
Self-reported number of hours of weekday sun exposure for the Hispanic Population
Time frame: 9 Months
Self-reported number of hours of weekday sun exposure of the Hispanic population after receiving the intervention
Time frame: Baseline
Self-reported number of hours of weekend sun exposure for the Hispanic Population
Time frame: 9 Months
Self-reported number of hours of weekend sun exposure for the Hispanic Population after receiving the intervention
Time frame: Baseline
Self-reported number of Sunburns for the Hispanic Population
Time frame: 9 Months
Self-reported number of Sunburns for the Hispanic Population after receiving the intervention
Time frame: Baseline
Self-reported number on a scale from 1=never to 5=always intentional tanning for the Hispanic Population
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline
Participants with at least one indoor intentional tanning session for the Hispanic Population
Time frame: 9 Months
Participants with at least one indoor intentional tanning session for the Hispanic Population after receiving the intervention
Time frame: Baseline
Self-reported average hours spent outside during weekdays among the children of the participants in the Non-Hispanic White Population
Time frame: 12 months
Self-reported average hours spent outside during weekdays among the children of the participants in the Non-Hispanic White Population
Time frame: Baseline
Self-reported average hours spent outside during weekends among the children of the participants in the Non-Hispanic White Population
Time frame: 12 Months
Self-reported average hours spent outside during weekends among the children of the participants in the Non-Hispanic White Population
Time frame: Baseline
Self-reported number of red or painful sunburns among the children of the participants in the Non-Hispanic White Population
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
Time frame: Baseline
Self-reported number of hours for outdoor intentional tanning among the children of the participants in the Non-Hispanic White Population
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
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
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
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
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
Time frame: Baseline
Average Risk Participants children who wore a shirt with sleeves outdoors among the participants in the Non-Hispanic White Population
Time frame: 12 Month
Average Risk Participants children who wore a shirt with sleeves outdoors among the participants in the Non-Hispanic White Population
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
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
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
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
Time frame: Baseline
Children of the participants in the Non-Hispanic White High Risk Population who wore sunglasses outdoors
Time frame: 12 Months
Children of the participants in the Non-Hispanic White High Risk Population who wore sunglasses outdoors after receiving the intervention
Time frame: Baseline
Self-reported number of hours for wearing sunscreen outdoors among the children of the participants in the Non-Hispanic White Population
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
Time frame: Baseline
Self-reported number of hours of weekday sun exposure among the children of the participants in the Hispanic Population
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
Time frame: Baseline
Self-reported number of hours of weekend sun exposure among the children of the participants in the Hispanic Population
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
Time frame: Baseline
Self-reported number of hours of sun protection behaviors among the children of the participants in the Hispanic Population
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
Time frame: Baseline
Self-reported number of hours of outdoor intentional tanning among the children of the participants in the Hispanic Population
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
Time frame: Baseline
Self-reported number of Sunburns among the children of the participants in the Hispanic Population
Time frame: 9 Months
Self-reported number of Sunburns among the children of the participants in the Hispanic Population after receiving the intervention
Time frame: Baseline
Children of participants in the Hispanic Population who wore a hat before receiving the intervention
Time frame: 9 months
Children of participants in the Hispanic Population who wore a hat after receiving the intervention
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
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
Time frame: Baseline
Children of the participants in the Hispanic Average Risk Population who reported wearing a shirt with sleeves outdoors
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
Time frame: Baseline
Self-reported number of hours of wearing a shirt among the children of the participants in the Hispanic Population
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
Time frame: Baseline
Children of the participants in the Hispanic Population who reported wearing sunglasses
Time frame: 9 Months
Children of the participants in the Hispanic Population who reported wearing sunglasses, after receiving the intervention
Time frame: Baseline
Children of the participants in the Hispanic Average Risk Population wo reported wearing sunscreen
Time frame: 9 Months
Children of the participants in the Hispanic Average Risk Population wo reported wearing sunscreen, after receiving the intervention
Time frame: Baseline
Self-reported number of hours of wearing sunscreen among the children of the participants in the Hispanic High Risk Population
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
H. Lee Moffitt Cancer Center and Research Institute
Other
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