NCT03509467

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,054

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2021

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 21, 2023

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

5.6 years

First QC Date

April 17, 2018

Results QC Date

February 4, 2022

Last Update Submit

December 4, 2025

Conditions

Melanoma (Skin)Squamous Cell CarcinomaSquamous Cell CancerSkin CancerBasal Cell CarcinomaBasal Cell Cancer

Keywords

skin cancer preventioneducational materialsskin cancer riskquestionnaireMC1R genotype

Outcome Measures

Primary Outcomes (40)

  • Weekday Sun Exposure - NHW - Baseline

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

    Baseline

  • Weekday Sun Exposure - NHW - After Intervention

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

    12 months

  • Weekend Sun Exposure - NHW - Baseline

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

    Baseline

  • Weekend Sun Exposure - NHW - After Intervention

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

    12 Months

  • Sunburns - NHW - Baseline

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

    Baseline

  • Sunburns - NHW - After Intervention

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

    12 Months

  • Outdoor Intentional Tanning - NHW - Baseline

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

    Baseline

  • Outdoor Intentional Tanning - NHW - After Intervention

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

    12 Months

  • Proportion of Participants Wearing a Hat - NHW - Baseline

    Proportion who practiced wearing a hat for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    Baseline

  • Proportion of Participants Wearing a Hat - NHW - After Intervention

    Proportion who practiced wearing a hat for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    12 Months

  • Seeking Shade - NHW - Baseline

    Self-reported number of hours for seeking shade or using an umbrella outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    Baseline

  • Seeking Shade - NHW - After Intervention

    Self-reported number of hours for seeking shade or using an umbrella outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    12 Months

  • Wearing a Shirt - NHW - Baseline

    Self-reported number of hours for wearing a shirt with sleeves outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    Baseline

  • Wearing a Shirt - NHW - After Intervention

    Self-reported number of hours wearing a shirt with sleeves outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    12 Months

  • Wearing Sunglasses - NHW - Baseline

    Self-reported number of hours for wearing sunglasses outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    Baseline

  • Wearing Sunglasses - NHW - After Intervention

    Self-reported number of hours wearing sunglasses outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    12 Months

  • Wearing Sunscreen - NHW - Baseline

    Self-reported number of hours for wearing sunscreen outdoors for the Non-Hispanic White Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    Baseline

  • Wearing Sunscreen - NHW - After Intervention

    Self-reported number of hours wearing sunscreen outdoors for the Non-Hispanic White Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    12 Months

  • Participants With Indoor Intentional Tanning - NHW - Baseline

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

    Baseline

  • Participants With Indoor Intentional Tanning - NHW - After Intervention

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

    12 Months

  • Weekday Sun Exposure - Hispanic Population Baseline

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

    Baseline

  • Weekday Sun Exposure - Hispanic Population After Intervention

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

    9 Months

  • Weekend Sun Exposure - Hispanic Population - Baseline

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

    Baseline

  • Weekend Sun Exposure - Hispanic Population - After Intervention

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

    9 Months

  • Sunburns - Hispanic Population - Baseline

    Self-reported number of Sunburns for the Hispanic Population

    Baseline

  • Sunburns - Hispanic Population - After Intervention

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

    9 Months

  • Outdoor Intentional Tanning - Hispanic Population - Baseline

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

    Baseline

  • Outdoor Intentional Tanning - Hispanic Population - After Intervention

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

    9 Months

  • Proportion of Participants Wearing a Hat - Hispanic Population - Baseline

    Proportion who practiced wearing a hat Often to Always for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    Baseline

  • Proportion of Participants Wearing a Hat - Hispanic Population - After Intervention

    Proportion who practiced wearing a hat Often to Always for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    9 months

  • Seeking Shade - Hispanic Population - Baseline

    Self-reported number of hours of seeking shade or using an umbrella for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    Baseline

  • Seeking Shade - Hispanic Population - After Intervention

    Self-reported number of hours of seeking shade or using an umbrella for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    9 Months

  • Wearing a Shirt - Hispanic Population - Baseline

    Self-reported number of hours of wearing a shirt for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    Baseline

  • Wearing a Shirt - Hispanic Population - After Intervention

    Self-reported number of hours of wearing a shirt with sleeves outdoors for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    9 Months

  • Wearing Sunglasses - Hispanic Population - Baseline

    Self-reported number of hours of wearing sunglasses for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    Baseline

  • Wearing Sunglasses - Hispanic Population - After Intervention

    Self-reported number of hours of wearing sunglasses for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    9 Months

  • Wearing Sunscreen - Hispanic Population - Baseline

    Self-reported number of hours of wearing sunscreen for the Hispanic Population. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    Baseline

  • Wearing Sunscreen - Hispanic Population - After Intervention

    Self-reported number of hours of wearing sunscreen for the Hispanic Population after receiving the intervention. This is a population predicted marginal proportion estimated by running a generalized estimating equation with the outcome modeled as a repeated binomial distribution (practiced the behavior often to always vs. sometimes, rarely, or never measured at both follow-ups) and using a logit link function. The model covariates included the baseline measure, any imbalanced baseline measures, predictors of missingness, and predictors of outcome.

    9 Months

  • Participants With Intentional Indoor Tanning - Hispanic Population - Baseline

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

    Baseline

  • Participants With Intentional Indoor Tanning - Hispanic Population - After Intervention

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

    9 Months

Secondary Outcomes (46)

  • Weekday Sun Exposure - NHW Children - Baseline

    Baseline

  • Weekday Sun Exposure - NHW Children - After Intervention

    12 months

  • Weekend Sun Exposure - NHW Children - Baseline

    Baseline

  • Weekend Sun Exposure - NHW Children - After Intervention

    12 Months

  • Sunburns - NHW Children - Baseline

    Baseline

  • +41 more secondary outcomes

Study Arms (4)

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.

Behavioral: Personalized InformationOther: 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.

Behavioral: Personalized InformationOther: 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.

Behavioral: Standard InformationOther: 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.

Behavioral: Standard InformationOther: DNA Extraction Determination of MC1R Genotypes

Interventions

Personalized InformationBEHAVIORAL

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

Also known as: educational materials
Intervention Group AIntervention Group B
Standard InformationBEHAVIORAL

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

Also known as: educational materials
Control Group AControl Group B
DNA Extraction Determination of MC1R GenotypesOTHER

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.

Also known as: risk factor
Control Group AControl Group BIntervention Group AIntervention Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Ponce School of Medicine

Ponce, 00716, Puerto Rico

Location

Related Publications (5)

  • 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.

    PMID: 38028436DERIVED

  • Lacson 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.

    PMID: 37708699DERIVED

  • Lacson 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.

    PMID: 36629029DERIVED

  • Lacson 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.

    PMID: 35845857DERIVED

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

    PMID: 35552458DERIVED

MeSH Terms

Conditions

MelanomaCarcinoma, Squamous CellNeoplasms, Squamous CellSkin NeoplasmsCarcinoma, Basal CellNeoplasms, Basal Cell

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Peter Kanetsky, PhD, MPH
Organization
Moffitt Cancer Center
Peter.Kanetsky@moffitt.org
813-745-3988

Study Officials

  • Peter Kanetsky, Ph.D

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 26, 2018

Study Start

August 3, 2015

Primary Completion

February 19, 2021

Study Completion

February 19, 2021

Last Updated

December 19, 2025

Results First Posted

November 21, 2023

Record last verified: 2025-12

Locations

US(1)PR(1)