Using MC1R Genotype to Impact Melanoma Risk Behavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,054
- 试验地点
- 4
- 主要终点
- Weekday Sun Exposure - NHW - Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Weekday Sun Exposure - NHW - Baseline
时间窗: Baseline
Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population
Weekday Sun Exposure - NHW - After Intervention
时间窗: 12 months
Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population after they received the intervention
Sunburns - NHW - After Intervention
时间窗: 12 Months
Self-reported number of red or painful sunburns for the Non-Hispanic White Population after receiving the intervention
Weekend Sun Exposure - NHW - After Intervention
时间窗: 12 Months
Self-reported average hours spent outside during weekends for the Non-Hispanic White Population after receiving the intervention
Sunburns - NHW - Baseline
时间窗: Baseline
Self-reported number of red or painful sunburns for the Non-Hispanic White Population
Seeking Shade - NHW - Baseline
时间窗: 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.
Seeking Shade - NHW - After Intervention
时间窗: 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.
Participants With Indoor Intentional Tanning - NHW - Baseline
时间窗: Baseline
Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population
Participants With Indoor Intentional Tanning - NHW - After Intervention
时间窗: 12 Months
Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population after receiving the intervention
Weekend Sun Exposure - Hispanic Population - Baseline
时间窗: Baseline
Self-reported number of hours of weekend sun exposure for the Hispanic Population
Sunburns - Hispanic Population - Baseline
时间窗: Baseline
Self-reported number of Sunburns for the Hispanic Population
Wearing a Shirt - Hispanic Population - Baseline
时间窗: 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.
Proportion of Participants Wearing a Hat - NHW - Baseline
时间窗: 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.
Weekend Sun Exposure - NHW - Baseline
时间窗: Baseline
Self-reported average hours spent outside during weekends for the Non-Hispanic White Population
Outdoor Intentional Tanning - NHW - Baseline
时间窗: Baseline
Self-reported number on a scale from 1=never to 5=always for outdoor intentional tanning for the Non-Hispanic White Population
Outdoor Intentional Tanning - NHW - After Intervention
时间窗: 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
Sunburns - Hispanic Population - After Intervention
时间窗: 9 Months
Self-reported number of Sunburns for the Hispanic Population after receiving the intervention
Wearing Sunglasses - Hispanic Population - After Intervention
时间窗: 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.
Wearing Sunscreen - Hispanic Population - After Intervention
时间窗: 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.
Proportion of Participants Wearing a Hat - NHW - After Intervention
时间窗: 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.
Wearing Sunglasses - NHW - Baseline
时间窗: 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.
Seeking Shade - Hispanic Population - After Intervention
时间窗: 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.
Wearing Sunglasses - NHW - After Intervention
时间窗: 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.
Wearing Sunscreen - NHW - Baseline
时间窗: 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.
Wearing Sunscreen - NHW - After Intervention
时间窗: 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.
Weekday Sun Exposure - Hispanic Population After Intervention
时间窗: 9 Months
Self-reported number of hours of weekday sun exposure of the Hispanic population after receiving the intervention
Outdoor Intentional Tanning - Hispanic Population - Baseline
时间窗: Baseline
Self-reported number on a scale from 1=never to 5=always intentional tanning for the Hispanic Population
Proportion of Participants Wearing a Hat - Hispanic Population - After Intervention
时间窗: 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.
Seeking Shade - Hispanic Population - Baseline
时间窗: 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.
Wearing Sunglasses - Hispanic Population - Baseline
时间窗: 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.
Wearing a Shirt - NHW - Baseline
时间窗: 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.
Wearing a Shirt - NHW - After Intervention
时间窗: 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.
Weekday Sun Exposure - Hispanic Population Baseline
时间窗: Baseline
Self-reported number of hours of weekday sun exposure for the Hispanic Population
Weekend Sun Exposure - Hispanic Population - After Intervention
时间窗: 9 Months
Self-reported number of hours of weekend sun exposure for the Hispanic Population after receiving the intervention
Outdoor Intentional Tanning - Hispanic Population - After Intervention
时间窗: 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
Proportion of Participants Wearing a Hat - Hispanic Population - Baseline
时间窗: 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.
Participants With Intentional Indoor Tanning - Hispanic Population - After Intervention
时间窗: 9 Months
Participants with at least one indoor intentional tanning session for the Hispanic Population after receiving the intervention
Wearing a Shirt - Hispanic Population - After Intervention
时间窗: 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.
Wearing Sunscreen - Hispanic Population - Baseline
时间窗: 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.
Participants With Intentional Indoor Tanning - Hispanic Population - Baseline
时间窗: Baseline
Participants with at least one indoor intentional tanning session for the Hispanic Population
次要结局
- Weekday Sun Exposure - NHW Children - Baseline(Baseline)
- Weekday Sun Exposure - NHW Children - After Intervention(12 months)
- Wearing a Hat - Hispanic Children Population - Baseline(Baseline)
- Sunburns - NHW Children - Baseline(Baseline)
- Seeking Shade - NHW Children - After Intervention(12 Months)
- Weekend Sun Exposure - NHW Children - After Intervention(12 Months)
- Seeking Shade - NHW Children - Baseline(Baseline)
- Wearing Sunglasses - High Risk NHW Children - After Intervention(12 Months)
- Wearing Sunscreen - NHW Children - Baseline(Baseline)
- Weekday Sun Exposure - Hispanic Children Population After Intervention(9 Months)
- Weekend Sun Exposure - NHW Children - Baseline(Baseline)
- Outdoor International Tanning - NHW Children - Baseline(Baseline)
- Wearing a Hat - NHW Children - Baseline(Baseline)
- Wearing a Hat - NHW Children - After Intervention(12 Months)
- Wearing a Shirt - High Risk NHW Children - Baseline(12 Months)
- Wearing a Shirt - High Risk NHW Children - After Intervention(12 Months)
- Wearing Sunglasses -High Risk NHW Children - Baseline(Baseline)
- Weekday Sun Exposure - Hispanic Children Population Baseline(Baseline)
- Weekend Sun Exposure - Hispanic Children Population - Baseline(Baseline)
- Sunburns - Hispanic Children Population - After Intervention(9 Months)
- Wearing a Hat - Hispanic Children Population - After Intervention(9 months)
- Wearing Sunglasses - Hispanic Children Population - After Intervention(9 Months)
- Wearing Sunscreen - Hispanic Children High Risk Population - Baseline(Baseline)
- Sunburns - NHW Children - After Intervention(12 Months)
- Outdoor Intentional Tanning - NHW Children - After Intervention(12 Months)
- Sun Protection Behaviors - Hispanic Children Population - Baseline(Baseline)
- Wearing a Shirt - Average Risk Hispanic Children Population - Baseline(Baseline)
- Wearing a Shirt - Hispanic Children Population - After Intervention(9 Months)
- Wearing Sunscreen - Hispanic Children Average Risk Population - Baseline(Baseline)
- Wearing Sunscreen - Hispanic Children Population - After Intervention(9 Months)
- Wearing a Shirt - Average Risk NHW Children - Baseline(Baseline)
- Wearing a Shirt - Average Risk NHW Children - After Intervention(12 Month)
- Wearing Sunglasses - Average Risk NHW Children - Baseline(Baseline)
- Wearing Sunglasses - Average Risk NHW Children - After Intervention(12 Months)
- Wearing Sunscreen - NHW Children - After Intervention(12 Months)
- Weekend Sun Exposure - Hispanic Children Population - After Intervention(9 Months)
- Wearing a Shirt - Hispanic Children High Risk Population - After Intervention(9 Months)
- Wearing Sunglasses - Hispanic Children Population - Baseline(Baseline)
- Wearing Sunscreen - Hispanic High Risk Children Population - After Intervention(9 Months)
- Sun Protection Behaviors - Hispanic Children Population - After Intervention(9 Months)
- Outdoor Intentional Tanning - Hispanic Children Population - Baseline(Baseline)
- Outdoor Intentional Tanning - Hispanic Children Population - After Intervention(9 Months)
- Sunburns - Hispanic Children Population - Baseline(Baseline)
- Seeking Shade - Hispanic Children Population - Baseline(Baseline)
- Seeking Shade - Hispanic Children Population - After Intervention(9 Months)
- Wearing a Shirt - Hispanic Children High Risk Population - Baseline(Baseline)