Clinical trial NCT03509467: Using MC1R Genotype to Impact Melanoma Risk Behavior
Official title: Using MC1R Genotype to Impact Melanoma Risk Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Ponce Health Sciences University
name: University of South Florida
name: American Cancer Society, Inc.
First posted: 2018-04-26
Enrollment: 2054
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Weekday Sun Exposure - NHW - Baseline
timeFrame: Baseline
measure: Weekday Sun Exposure - NHW - After Intervention
timeFrame: 12 months
measure: Weekend Sun Exposure - NHW - Baseline
timeFrame: Baseline
measure: Weekend Sun Exposure - NHW - After Intervention
timeFrame: 12 Months
measure: Sunburns - NHW - Baseline
timeFrame: Baseline
measure: Sunburns - NHW - After Intervention
timeFrame: 12 Months
measure: Outdoor Intentional Tanning - NHW - Baseline
timeFrame: Baseline
measure: Outdoor Intentional Tanning - NHW - After Intervention
timeFrame: 12 Months
measure: Proportion of Participants Wearing a Hat - NHW - Baseline
timeFrame: Baseline
measure: Proportion of Participants Wearing a Hat - NHW - After Intervention
timeFrame: 12 Months
measure: Seeking Shade - NHW - Baseline
timeFrame: Baseline
measure: Seeking Shade - NHW - After Intervention
timeFrame: 12 Months
measure: Wearing a Shirt - NHW - Baseline
timeFrame: Baseline
measure: Wearing a Shirt - NHW - After Intervention
timeFrame: 12 Months
measure: Wearing Sunglasses - NHW - Baseline
timeFrame: Baseline
measure: Wearing Sunglasses - NHW - After Intervention
timeFrame: 12 Months
measure: Wearing Sunscreen - NHW - Baseline
timeFrame: Baseline
measure: Wearing Sunscreen - NHW - After Intervention
timeFrame: 12 Months
measure: Participants With Indoor Intentional Tanning - NHW - Baseline
timeFrame: Baseline
measure: Participants With Indoor Intentional Tanning - NHW - After Intervention
timeFrame: 12 Months
measure: Weekday Sun Exposure - Hispanic Population Baseline
timeFrame: Baseline
measure: Weekday Sun Exposure - Hispanic Population After Intervention
timeFrame: 9 Months
measure: Weekend Sun Exposure - Hispanic Population - Baseline
timeFrame: Baseline
measure: Weekend Sun Exposure - Hispanic Population - After Intervention
timeFrame: 9 Months
measure: Sunburns - Hispanic Population - Baseline
timeFrame: Baseline
measure: Sunburns - Hispanic Population - After Intervention
timeFrame: 9 Months
measure: Outdoor Intentional Tanning - Hispanic Population - Baseline
timeFrame: Baseline
measure: Outdoor Intentional Tanning - Hispanic Population - After Intervention
timeFrame: 9 Months
measure: Proportion of Participants Wearing a Hat - Hispanic Population - Baseline
timeFrame: Baseline
measure: Proportion of Participants Wearing a Hat - Hispanic Population - After Intervention
timeFrame: 9 months
measure: Seeking Shade - Hispanic Population - Baseline
timeFrame: Baseline
measure: Seeking Shade - Hispanic Population - After Intervention
timeFrame: 9 Months
measure: Wearing a Shirt - Hispanic Population - Baseline
timeFrame: Baseline
measure: Wearing a Shirt - Hispanic Population - After Intervention
timeFrame: 9 Months
measure: Wearing Sunglasses - Hispanic Population - Baseline
timeFrame: Baseline
measure: Wearing Sunglasses - Hispanic Population - After Intervention
timeFrame: 9 Months
measure: Wearing Sunscreen - Hispanic Population - Baseline
timeFrame: Baseline
measure: Wearing Sunscreen - Hispanic Population - After Intervention
timeFrame: 9 Months
measure: Participants With Intentional Indoor Tanning - Hispanic Population - Baseline
timeFrame: Baseline
measure: Participants With Intentional Indoor Tanning - Hispanic Population - After Intervention
timeFrame: 9 Months
Secondary outcomes:
measure: Weekday Sun Exposure - NHW Children - Baseline
timeFrame: Baseline
measure: Weekday Sun Exposure - NHW Children - After Intervention
timeFrame: 12 months
measure: Weekend Sun Exposure - NHW Children - Baseline
timeFrame: Baseline
measure: Weekend Sun Exposure - NHW Children - After Intervention
timeFrame: 12 Months
measure: Sunburns - NHW Children - Baseline
timeFrame: Baseline
measure: Sunburns - NHW Children - After Intervention
timeFrame: 12 Months
measure: Outdoor International Tanning - NHW Children - Baseline
timeFrame: Baseline
measure: Outdoor Intentional Tanning - NHW Children - After Intervention
timeFrame: 12 Months
measure: Wearing a Hat - NHW Children - Baseline
timeFrame: Baseline
measure: Wearing a Hat - NHW Children - After Intervention
timeFrame: 12 Months
measure: Seeking Shade - NHW Children - Baseline
timeFrame: Baseline
measure: Seeking Shade - NHW Children - After Intervention
timeFrame: 12 Months
measure: Wearing a Shirt - Average Risk NHW Children - Baseline
timeFrame: Baseline
measure: Wearing a Shirt - Average Risk NHW Children - After Intervention
timeFrame: 12 Month
measure: Wearing a Shirt - High Risk NHW Children - Baseline
timeFrame: 12 Months
measure: Wearing a Shirt - High Risk NHW Children - After Intervention
timeFrame: 12 Months
measure: Wearing Sunglasses - Average Risk NHW Children - Baseline
timeFrame: Baseline
measure: Wearing Sunglasses - Average Risk NHW Children - After Intervention
timeFrame: 12 Months
measure: Wearing Sunglasses -High Risk NHW Children - Baseline
timeFrame: Baseline
measure: Wearing Sunglasses - High Risk NHW Children - After Intervention
timeFrame: 12 Months
measure: Wearing Sunscreen - NHW Children - Baseline
timeFrame: Baseline
measure: Wearing Sunscreen - NHW Children - After Intervention
timeFrame: 12 Months
measure: Weekday Sun Exposure - Hispanic Children Population Baseline
timeFrame: Baseline
measure: Weekday Sun Exposure - Hispanic Children Population After Intervention
timeFrame: 9 Months
measure: Weekend Sun Exposure - Hispanic Children Population - Baseline
timeFrame: Baseline
measure: Weekend Sun Exposure - Hispanic Children Population - After Intervention
timeFrame: 9 Months
measure: Sun Protection Behaviors - Hispanic Children Population - Baseline
timeFrame: Baseline
measure: Sun Protection Behaviors - Hispanic Children Population - After Intervention
timeFrame: 9 Months
measure: Outdoor Intentional Tanning - Hispanic Children Population - Baseline
timeFrame: Baseline
measure: Outdoor Intentional Tanning - Hispanic Children Population - After Intervention
timeFrame: 9 Months
measure: Sunburns - Hispanic Children Population - Baseline
timeFrame: Baseline
measure: Sunburns - Hispanic Children Population - After Intervention
timeFrame: 9 Months
measure: Wearing a Hat - Hispanic Children Population - Baseline
timeFrame: Baseline
measure: Wearing a Hat - Hispanic Children Population - After Intervention
timeFrame: 9 months
measure: Seeking Shade - Hispanic Children Population - Baseline
timeFrame: Baseline
measure: Seeking Shade - Hispanic Children Population - After Intervention
timeFrame: 9 Months
measure: Wearing a Shirt - Average Risk Hispanic Children Population - Baseline
timeFrame: Baseline
measure: Wearing a Shirt - Hispanic Children Population - After Intervention
timeFrame: 9 Months
measure: Wearing a Shirt - Hispanic Children High Risk Population - Baseline
timeFrame: Baseline
measure: Wearing a Shirt - Hispanic Children High Risk Population - After Intervention
timeFrame: 9 Months
measure: Wearing Sunglasses - Hispanic Children Population - Baseline
timeFrame: Baseline
measure: Wearing Sunglasses - Hispanic Children Population - After Intervention
timeFrame: 9 Months
measure: Wearing Sunscreen - Hispanic Children Average Risk Population - Baseline
timeFrame: Baseline
measure: Wearing Sunscreen - Hispanic Children Population - After Intervention
timeFrame: 9 Months
measure: Wearing Sunscreen - Hispanic Children High Risk Population - Baseline
timeFrame: Baseline
measure: Wearing Sunscreen - Hispanic High Risk Children Population - After Intervention
timeFrame: 9 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Peter Kanetsky, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.