Melanoma (Skin)NCT03509467
Using MC1R Genotype to Impact Melanoma Risk Behavior
A study testing Personalized Information, Standard Information and DNA Extraction Determination of MC1R Genotypes in people with Melanoma (Skin) and Squamous Cell Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma (Skin), Squamous Cell Carcinoma, Squamous Cell Cancer
- What is being tested?
- Personalized Information, Standard Information and DNA Extraction Determination of MC1R Genotypes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,054 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Aug 2015to 19 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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.
- Conditions
- Melanoma (Skin), Squamous Cell Carcinoma, Squamous Cell Cancer, Skin Cancer, Basal Cell Carcinoma, Basal Cell Cancer
- Being tested
- Personalized Information, Standard Information, DNA Extraction Determination of MC1R Genotypes
- Keywords
- skin cancer prevention, educational materials, skin cancer risk, questionnaire, MC1R genotype
- Medical subject headings
- Melanoma, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell, Skin Neoplasms, Carcinoma, Basal Cell, Neoplasms, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized InformationBehavioural
Also called educational materials
Personalized information about ways that participants can protect themselves and their child from developing melanoma.
Standard InformationBehavioural
Also called educational materials
Standard information about ways that participants can protect themselves and their child from developing melanoma.
DNA Extraction Determination of MC1R GenotypesOther
Also called risk factor
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group A | Experimental | 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. Receives: Behavioral: Personalized Information; Other: DNA Extraction Determination of MC1R Genotypes |
| Intervention Group B | Experimental | 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. Receives: Behavioral: Personalized Information; Other: DNA Extraction Determination of MC1R Genotypes |
| Control Group A | Placebo comparator | 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. Receives: Behavioral: Standard Information; Other: DNA Extraction Determination of MC1R Genotypes |
| Control Group B | Placebo comparator | 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. Receives: Behavioral: Standard Information; Other: DNA Extraction Determination of MC1R Genotypes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekday Sun Exposure - NHW - Baseline
Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population
Measured: 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
Measured: 12 months
Weekend Sun Exposure - NHW - Baseline
Self-reported average hours spent outside during weekends for the Non-Hispanic White Population
Measured: 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
Measured: 12 Months
Sunburns - NHW - Baseline
Self-reported number of red or painful sunburns for the Non-Hispanic White Population
Measured: Baseline
Sunburns - NHW - After Intervention
Self-reported number of red or painful sunburns for the Non-Hispanic White Population after receiving the intervention
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Months
Participants With Indoor Intentional Tanning - NHW - Baseline
Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population
Measured: 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
Measured: 12 Months
Weekday Sun Exposure - Hispanic Population Baseline
Self-reported number of hours of weekday sun exposure for the Hispanic Population
Measured: 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
Measured: 9 Months
Weekend Sun Exposure - Hispanic Population - Baseline
Self-reported number of hours of weekend sun exposure for the Hispanic Population
Measured: 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
Measured: 9 Months
Sunburns - Hispanic Population - Baseline
Self-reported number of Sunburns for the Hispanic Population
Measured: Baseline
Sunburns - Hispanic Population - After Intervention
Self-reported number of Sunburns for the Hispanic Population after receiving the intervention
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 Months
Participants With Intentional Indoor Tanning - Hispanic Population - Baseline
Participants with at least one indoor intentional tanning session for the Hispanic Population
Measured: 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
Measured: 9 Months
Secondary outcomes (46)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 9 Months
Sunburns - Hispanic Children Population - Baseline
Self-reported number of Sunburns among the children of the participants in the Hispanic Population
Measured: 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
Measured: 9 Months
Wearing a Hat - Hispanic Children Population - Baseline
Children of participants in the Hispanic Population who wore a hat before receiving the intervention
Measured: Baseline
Wearing a Hat - Hispanic Children Population - After Intervention
Children of participants in the Hispanic Population who wore a hat after receiving the intervention
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 9 Months
Wearing Sunglasses - Hispanic Children Population - Baseline
Children of the participants in the Hispanic Population who reported wearing sunglasses
Measured: Baseline
Wearing Sunglasses - Hispanic Children Population - After Intervention
Children of the participants in the Hispanic Population who reported wearing sunglasses, after receiving the intervention
Measured: 9 Months
Wearing Sunscreen - Hispanic Children Average Risk Population - Baseline
Children of the participants in the Hispanic Average Risk Population wo reported wearing sunscreen
Measured: 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
Measured: 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
Measured: 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
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start3 Aug 2015
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ponce Health Sciences University, University of South Florida, American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Peter Kanetsky, Ph.D, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509467
- Sponsor's protocol ID
- MCC-17984
- Other IDs
- MCC-19461
- Status last verified
- Dec 2025
- First submitted
- 17 Apr 2018
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rivera Rivera JN, Lacson JCA, Kim Y, Roetzheim RG, Sutton SK, Soto-Torres B, Vadaparampil ST, Kanetsky PA. Sharing and seeking information about skin cancer risk and prevention among Hispanic people from Florida and Puerto Rico. PEC Innov. 2023 Nov 14;3:100232. doi: 10.1016/j.pecinn.2023.100232. eCollection 2023 Dec 15.
PubMed 38028436Lacson JCA, Sutton SK, Kim Y, Roetzheim RG, Vadaparampil ST, Soto-Torres B, Kanetsky PA. Predictors of correct recall of genetic risk information among Hispanic individuals in Florida and Puerto Rico. Patient Educ Couns. 2023 Dec;117:107978. doi: 10.1016/j.pec.2023.107978. Epub 2023 Sep 11.
PubMed 37708699Lacson JCA, Kim Y, Roetzheim RG, Sutton SK, Vadaparampil ST, Kanetsky PA. Predictors of genetic risk recall among the participants of a randomized controlled precision prevention trial against melanoma. Genet Med. 2023 Apr;25(4):100005. doi: 10.1016/j.gim.2023.100005. Epub 2023 Jan 7.
PubMed 36629029Lacson JCA, Doyle SH, Del Rio J, Forgas SM, Carvajal R, Gonzalez-Calderon G, Feliciano AR, Kim Y, Roetzheim RG, Sutton SK, Vadaparampil ST, Soto-Torres B, Kanetsky PA. A randomized clinical trial of precision prevention materials incorporating MC1R genetic risk to improve skin cancer prevention activities among Hispanics. Cancer Res Commun. 2022 Jan;2(1):28-38. doi: 10.1158/2767-9764.crc-21-0114. Epub 2022 Jan 11.
PubMed 35845857Lacson 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.
PubMed 35552458
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using MC1R Genotype to Impact Melanoma Risk Behavior
- ClinicalTrials.gov ID
- NCT03509467
- Acronym / sponsor ID
- MCC-17984
- Conditions
- Melanoma (Skin), Squamous Cell Carcinoma, Squamous Cell Cancer, Skin Cancer, Basal Cell Carcinoma, Basal Cell Cancer
- Keywords
- skin cancer prevention, educational materials, skin cancer risk, questionnaire, MC1R genotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,054 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Ponce Health Sciences University, University of South Florida, American Cancer Society, Inc.
- Study start
- 3 Aug 2015 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Group A | Experimental | Behavioral: Personalized Information, Other: DNA Extraction Determination of MC1R GenotypesIntervention 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 | Experimental | Behavioral: Personalized Information, Other: DNA Extraction Determination of MC1R GenotypesIntervention 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 | Placebo comparator | Behavioral: Standard Information, Other: DNA Extraction Determination of MC1R GenotypesControl 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 | Placebo comparator | Behavioral: Standard Information, Other: DNA Extraction Determination of MC1R GenotypesControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized InformationAlso: educational materialsPersonalized information about ways that participants can protect themselves and their child from developing melanoma. | Behavioural | Intervention Group A, Intervention Group B |
| Standard InformationAlso: educational materialsStandard information about ways that participants can protect themselves and their child from developing melanoma. | Behavioural | Control Group A, Control Group B |
| DNA Extraction Determination of MC1R GenotypesAlso: risk factorAfter 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 | Control Group A, Control Group B, Intervention Group A, Intervention Group B |
Primary outcome
Weekday Sun Exposure - NHW - Baseline
Time frame: Baseline
Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population
Weekday Sun Exposure - NHW - After Intervention
Time frame: 12 months
Self-reported average hours spent outside during weekdays for the Non-Hispanic White Population after they received the intervention
Weekend Sun Exposure - NHW - Baseline
Time frame: Baseline
Self-reported average hours spent outside during weekends for the Non-Hispanic White Population
Weekend Sun Exposure - NHW - After Intervention
Time frame: 12 Months
Self-reported average hours spent outside during weekends for the Non-Hispanic White Population after receiving the intervention
Sunburns - NHW - Baseline
Time frame: Baseline
Self-reported number of red or painful sunburns for the Non-Hispanic White Population
Sunburns - NHW - After Intervention
Time frame: 12 Months
Self-reported number of red or painful sunburns for the Non-Hispanic White Population after receiving the intervention
Outdoor Intentional Tanning - NHW - Baseline
Time frame: Baseline
Self-reported number on a scale from 1=never to 5=always for outdoor intentional tanning for the Non-Hispanic White Population
Outdoor Intentional Tanning - NHW - After Intervention
Time frame: 12 Months
Self-reported number on a scale from 1=never to 5=always outdoor intentional tanning for the Non-Hispanic White Population after receiving the intervention
Proportion of Participants Wearing a Hat - NHW - Baseline
Time frame: Baseline
Proportion who practiced wearing a hat for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Proportion of Participants Wearing a Hat - NHW - After Intervention
Time frame: 12 Months
Proportion who practiced wearing a hat for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Seeking Shade - NHW - Baseline
Time frame: Baseline
Self-reported number of hours for seeking shade or using an umbrella outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Seeking Shade - NHW - After Intervention
Time frame: 12 Months
Self-reported number of hours for seeking shade or using an umbrella outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing a Shirt - NHW - Baseline
Time frame: Baseline
Self-reported number of hours for wearing a shirt with sleeves outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing a Shirt - NHW - After Intervention
Time frame: 12 Months
Self-reported number of hours wearing a shirt with sleeves outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing Sunglasses - NHW - Baseline
Time frame: Baseline
Self-reported number of hours for wearing sunglasses outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing Sunglasses - NHW - After Intervention
Time frame: 12 Months
Self-reported number of hours wearing sunglasses outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing Sunscreen - NHW - Baseline
Time frame: Baseline
Self-reported number of hours for wearing sunscreen outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing Sunscreen - NHW - After Intervention
Time frame: 12 Months
Self-reported number of hours wearing sunscreen outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Participants With Indoor Intentional Tanning - NHW - Baseline
Time frame: Baseline
Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population
Participants With Indoor Intentional Tanning - NHW - After Intervention
Time frame: 12 Months
Participants with at least one indoor intentional tanning session for the Non-Hispanic White Population after receiving the intervention
Weekday Sun Exposure - Hispanic Population Baseline
Time frame: Baseline
Self-reported number of hours of weekday sun exposure for the Hispanic Population
Weekday Sun Exposure - Hispanic Population After Intervention
Time frame: 9 Months
Self-reported number of hours of weekday sun exposure of the Hispanic population after receiving the intervention
Weekend Sun Exposure - Hispanic Population - Baseline
Time frame: Baseline
Self-reported number of hours of weekend sun exposure for the Hispanic Population
Weekend Sun Exposure - Hispanic Population - After Intervention
Time frame: 9 Months
Self-reported number of hours of weekend sun exposure for the Hispanic Population after receiving the intervention
Sunburns - Hispanic Population - Baseline
Time frame: Baseline
Self-reported number of Sunburns for the Hispanic Population
Sunburns - Hispanic Population - After Intervention
Time frame: 9 Months
Self-reported number of Sunburns for the Hispanic Population after receiving the intervention
Outdoor Intentional Tanning - Hispanic Population - Baseline
Time frame: Baseline
Self-reported number on a scale from 1=never to 5=always intentional tanning for the Hispanic Population
Outdoor Intentional Tanning - Hispanic Population - After Intervention
Time frame: 9 Months
Self-reported number on a scale from 1=never to 5=always outdoor intentional tanning for the Hispanic Population after receiving the intervention
Proportion of Participants Wearing a Hat - Hispanic Population - Baseline
Time frame: Baseline
Proportion who practiced wearing a hat Often to Always for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Proportion of Participants Wearing a Hat - Hispanic Population - After Intervention
Time frame: 9 months
Proportion who practiced wearing a hat Often to Always for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Seeking Shade - Hispanic Population - Baseline
Time frame: Baseline
Self-reported number of hours of seeking shade or using an umbrella for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Seeking Shade - Hispanic Population - After Intervention
Time frame: 9 Months
Self-reported number of hours of seeking shade or using an umbrella for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing a Shirt - Hispanic Population - Baseline
Time frame: Baseline
Self-reported number of hours of wearing a shirt for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing a Shirt - Hispanic Population - After Intervention
Time frame: 9 Months
Self-reported number of hours of wearing a shirt with sleeves outdoors for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing Sunglasses - Hispanic Population - Baseline
Time frame: Baseline
Self-reported number of hours of wearing sunglasses for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing Sunglasses - Hispanic Population - After Intervention
Time frame: 9 Months
Self-reported number of hours of wearing sunglasses for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing Sunscreen - Hispanic Population - Baseline
Time frame: Baseline
Self-reported number of hours of wearing sunscreen for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Wearing Sunscreen - Hispanic Population - After Intervention
Time frame: 9 Months
Self-reported number of hours of wearing sunscreen for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.
Participants With Intentional Indoor Tanning - Hispanic Population - Baseline
Time frame: Baseline
Participants with at least one indoor intentional tanning session for the Hispanic Population
Participants With Intentional Indoor Tanning - Hispanic Population - After Intervention
Time frame: 9 Months
Participants with at least one indoor intentional tanning session for the Hispanic Population after receiving the intervention
46 secondary outcomes
Weekday Sun Exposure - NHW Children - Baseline
Time frame: Baseline
Weekday Sun Exposure - NHW Children - After Intervention
Time frame: 12 months
Weekend Sun Exposure - NHW Children - Baseline
Time frame: Baseline
Weekend Sun Exposure - NHW Children - After Intervention
Time frame: 12 Months
Sunburns - NHW Children - Baseline
Time frame: Baseline
Sunburns - NHW Children - After Intervention
Time frame: 12 Months
Outdoor International Tanning - NHW Children - Baseline
Time frame: Baseline
Outdoor Intentional Tanning - NHW Children - After Intervention
Time frame: 12 Months
Wearing a Hat - NHW Children - Baseline
Time frame: Baseline
Wearing a Hat - NHW Children - After Intervention
Time frame: 12 Months
Seeking Shade - NHW Children - Baseline
Time frame: Baseline
Seeking Shade - NHW Children - After Intervention
Time frame: 12 Months
Wearing a Shirt - Average Risk NHW Children - Baseline
Time frame: Baseline
Wearing a Shirt - Average Risk NHW Children - After Intervention
Time frame: 12 Month
Wearing a Shirt - High Risk NHW Children - Baseline
Time frame: 12 Months
Wearing a Shirt - High Risk NHW Children - After Intervention
Time frame: 12 Months
Wearing Sunglasses - Average Risk NHW Children - Baseline
Time frame: Baseline
Wearing Sunglasses - Average Risk NHW Children - After Intervention
Time frame: 12 Months
Wearing Sunglasses -High Risk NHW Children - Baseline
Time frame: Baseline
Wearing Sunglasses - High Risk NHW Children - After Intervention
Time frame: 12 Months
Wearing Sunscreen - NHW Children - Baseline
Time frame: Baseline
Wearing Sunscreen - NHW Children - After Intervention
Time frame: 12 Months
Weekday Sun Exposure - Hispanic Children Population Baseline
Time frame: Baseline
Weekday Sun Exposure - Hispanic Children Population After Intervention
Time frame: 9 Months
Weekend Sun Exposure - Hispanic Children Population - Baseline
Time frame: Baseline
Weekend Sun Exposure - Hispanic Children Population - After Intervention
Time frame: 9 Months
Sun Protection Behaviors - Hispanic Children Population - Baseline
Time frame: Baseline
Sun Protection Behaviors - Hispanic Children Population - After Intervention
Time frame: 9 Months
Outdoor Intentional Tanning - Hispanic Children Population - Baseline
Time frame: Baseline
Outdoor Intentional Tanning - Hispanic Children Population - After Intervention
Time frame: 9 Months
Sunburns - Hispanic Children Population - Baseline
Time frame: Baseline
Sunburns - Hispanic Children Population - After Intervention
Time frame: 9 Months
Wearing a Hat - Hispanic Children Population - Baseline
Time frame: Baseline
Wearing a Hat - Hispanic Children Population - After Intervention
Time frame: 9 months
Seeking Shade - Hispanic Children Population - Baseline
Time frame: Baseline
Seeking Shade - Hispanic Children Population - After Intervention
Time frame: 9 Months
Wearing a Shirt - Average Risk Hispanic Children Population - Baseline
Time frame: Baseline
Wearing a Shirt - Hispanic Children Population - After Intervention
Time frame: 9 Months
Wearing a Shirt - Hispanic Children High Risk Population - Baseline
Time frame: Baseline
Wearing a Shirt - Hispanic Children High Risk Population - After Intervention
Time frame: 9 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38028436Rivera Rivera JN, Lacson JCA, Kim Y, Roetzheim RG, Sutton SK, Soto-Torres B, Vadaparampil ST, Kanetsky PA. Sharing and seeking information about skin cancer risk and prevention among Hispanic people from Florida and Puerto Rico. PEC Innov. 2023 Nov 14;3:100232. doi: 10.1016/j.pecinn.2023.100232. eCollection 2023 Dec 15.
- Derived from this study: PubMed 37708699Lacson JCA, Sutton SK, Kim Y, Roetzheim RG, Vadaparampil ST, Soto-Torres B, Kanetsky PA. Predictors of correct recall of genetic risk information among Hispanic individuals in Florida and Puerto Rico. Patient Educ Couns. 2023 Dec;117:107978. doi: 10.1016/j.pec.2023.107978. Epub 2023 Sep 11.
- Derived from this study: PubMed 36629029Lacson JCA, Kim Y, Roetzheim RG, Sutton SK, Vadaparampil ST, Kanetsky PA. Predictors of genetic risk recall among the participants of a randomized controlled precision prevention trial against melanoma. Genet Med. 2023 Apr;25(4):100005. doi: 10.1016/j.gim.2023.100005. Epub 2023 Jan 7.
- Derived from this study: PubMed 35845857Lacson JCA, Doyle SH, Del Rio J, Forgas SM, Carvajal R, Gonzalez-Calderon G, Feliciano AR, Kim Y, Roetzheim RG, Sutton SK, Vadaparampil ST, Soto-Torres B, Kanetsky PA. A randomized clinical trial of precision prevention materials incorporating MC1R genetic risk to improve skin cancer prevention activities among Hispanics. Cancer Res Commun. 2022 Jan;2(1):28-38. doi: 10.1158/2767-9764.crc-21-0114. Epub 2022 Jan 11.
- Derived from this study: PubMed 35552458Lacson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Kanetsky, Ph.D principal investigator
H. Lee Moffitt Cancer Center and Research Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Information, Standard Information and DNA Extraction Determination of MC1R Genotypes in people with Melanoma (Skin) and Squamous Cell Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekday Sun Exposure - NHW - Baseline (time frame: Baseline). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509467, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.