Using MC1R Genotype to Impact Melanoma Risk Behavior

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03509467

Collaborator

The Ponce Health Sciences University (Other), University of South Florida (Other), American Cancer Society, Inc. (Other)

2,293

Enrollment

Locations

Arms

85.9

Anticipated Duration (Months)

1146.5

Patients Per Site

13.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin) Squamous Cell Carcinoma Squamous Cell Cancer Skin Cancer Basal Cell Carcinoma Basal Cell Cancer	Behavioral: Personalized Information Behavioral: Standard Information Other: DNA Extraction Determination of MC1R Genotypes	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2293 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Using MC1R Genotype to Impact Melanoma Risk Behavior

Actual Study Start Date :

Aug 3, 2015

Actual Primary Completion Date :

Feb 19, 2021

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group A Intervention Group A: Non-Hispanic White Population Post determination of MC1R Genotypes, participants randomized to the intervention group, will receive personalized information about ways that they can protect themselves and their child from developing melanoma. By the end of the study, all participants will have had the opportunity to receive information about their inherited risk.	Behavioral: Personalized Information Personalized information about ways that participants can protect themselves and their child from developing melanoma. Other Names: educational materials Other: DNA Extraction Determination of MC1R Genotypes After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm. Other Names: risk factor
Experimental: Intervention Group B Intervention Group B: Hispanic Population Post determination of MC1R Genotypes, participants randomized to the intervention group, will receive personalized information about ways that they can protect themselves and their child from developing melanoma. By the end of the study, all participants will have had the opportunity to receive information about their inherited risk.	Behavioral: Personalized Information Personalized information about ways that participants can protect themselves and their child from developing melanoma. Other Names: educational materials Other: DNA Extraction Determination of MC1R Genotypes After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm. Other Names: risk factor
Placebo Comparator: Control Group A Control Group A: Non-Hispanic White Population Post determination of MC1R Genotypes, participants randomized to the control group, you will receive standard information about ways that they can protect themselves and their child from developing melanoma. By the end of the study, all participants will have had the opportunity to receive information about their inherited risk. Participants randomized into the control group, by the end of the study will also have had the opportunity to receive personalized information about ways they can protect themselves and their child from developing melanoma.	Behavioral: Standard Information Standard information about ways that participants can protect themselves and their child from developing melanoma. Other Names: educational materials Other: DNA Extraction Determination of MC1R Genotypes After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm. Other Names: risk factor
Placebo Comparator: Control Group B Control Group B: Hispanic Population Post determination of MC1R Genotypes, participants randomized to the control group, you will receive standard information about ways that they can protect themselves and their child from developing melanoma. By the end of the study, all participants will have had the opportunity to receive information about their inherited risk. Participants randomized into the control group, by the end of the study will also have had the opportunity to receive personalized information about ways they can protect themselves and their child from developing melanoma.	Behavioral: Standard Information Standard information about ways that participants can protect themselves and their child from developing melanoma. Other Names: educational materials Other: DNA Extraction Determination of MC1R Genotypes After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm. Other Names: risk factor

Outcome Measures

Primary Outcome Measures

Sun and Protection Behaviors - Impact of Risk and Prevention Education - Non-Hispanic White Population [Up to 12 months]
Rate of self-reported, post education changes per study arm: 1.) decrease in sun exposure, 2.) increase in sun protection.
Sun and Protection Behaviors - Impact of Risk and Prevention Education - Hispanic Population [Up to 9 months]
Rate of self-reported, post education changes per study arm: 1.) decrease in sun exposure, 2.) increase in sun protection
Skin Awareness and Examination - Impact of Risk and Prevention Education - Hispanic Population [Up to 9 months]
Rate of self-reported, post education changes per study arm: Increase in skin examinations.
Skin Awareness and Examination - Impact of Risk and Prevention Education - Non-Hispanic White Population [Up to 12 months]
Rate of self-reported, post education changes per study arm: Increase in skin examinations.

Secondary Outcome Measures

Impact of Receipt of MC1R Genotype on Sun Protection Behaviors in Children - Non-Hispanic White Population [Up to 12 months]
Impact of receipt of MC1R genotype on sun protection behaviors in children of study participants. Self-reported post education decreased number of sunburns.
Impact of Receipt of MC1R Genotype on Sun Protection Behaviors in Children - Hispanic Population [Up to 9 months]
Impact of receipt of MC1R genotype on sun protection behaviors in children of study participants. Self-reported post education decreased number of sunburns.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

CRITERIA FOR: NON-HISPANIC WHITE POPULATION

Investigators will recruit participants from the Family Medicine and General Internal Medicine clinics of the Morsani Center at the University of South Florida.
White, non-Hispanic patients who self-report a low phenotypic risk profile for development of melanoma and are able to read and speak English fluently.
18 years of age or older
Capable of giving informed consent
Potential participants will be screened for eligibility based on responses to questions about skin phenotypes, early detection behaviors and past history of melanoma.
After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.

CRITERIA FOR: HISPANIC POPULATION

Investigators will recruit participants living in Tampa Bay and Puerto Rico as part of the U54 Ponce Health Sciences University-Moffitt Cancer Center (PHSU-MCC) Partnership. In Tampa Bay, participants will be recruited from the Family Medicine and General Internal Medicine clinics of the Morsani Center at the University of South Florida, and from the Suncoast Community Health Centers.
Patients who self-report as Hispanics and are able to read and speak either Spanish or English fluently.
18 years of age or older
Capable of giving informed consent
Potential participants will be screened for eligibility based on responses to early detection behaviors and past history of melanoma.
After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.

Exclusion Criteria:

CRITERIA FOR: NON-HISPANIC WHITE POPULATION

Have had a skin examination within the past year.
Do not meet race/ethnicity criteria for their group
White, non-Hispanic group - participants reporting sun-sensitive phenotypes
A personal history of melanoma

CRITERIA FOR: HISPANIC POPULATION

Have had a skin examination within the past year.
Do not meet ethnicity criteria for their group
White, non-Hispanic group - participants reporting sun-sensitive phenotypes
Participants with a personal history of melanoma and/or more personal history of more than on squamous cell cancer (SCC) and/or Basal Cell Cancer (BCC)