N/A
N=2,054
Using MC1R Genotype to Impact Melanoma Risk Behavior
Melanoma (Skin) · Squamous Cell Carcinoma · Squamous Cell Cancer · Skin Cancer · Basal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03509467 ↗Enrolled (actual)
2,054
Serious AEs
—
Results posted
Nov 2023
Primary outcome: Primary: Weekday Sun Exposure - NHW - Baseline — 1.27; 1.30; 1.26; 1.29 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Personalized Information (Behavioral); Standard Information (Behavioral); DNA Extraction Determination of MC1R Genotypes (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weekday Sun Exposure - NHW - Baseline |
1.27; 1.30; 1.26; 1.29 | — |
| PRIMARY Weekday Sun Exposure - NHW - After Intervention |
1.09; 1.18; 1.09; 1.05 | — |
| PRIMARY Weekend Sun Exposure - NHW - Baseline |
2.17; 2.25; 2.25; 2.30 | — |
| PRIMARY Weekend Sun Exposure - NHW - After Intervention |
2.00; 2.08; 1.89; 1.89 | — |
| PRIMARY Sunburns - NHW - Baseline |
0.60; 0.66; 0.83; 0.85 | — |
| PRIMARY Sunburns - NHW - After Intervention |
0.29; 0.20; 0.27; 0.28 | — |
| PRIMARY Outdoor Intentional Tanning - NHW - Baseline |
2.01; 2.03; 1.96; 1.95 | — |
| PRIMARY Outdoor Intentional Tanning - NHW - After Intervention |
1.79; 1.82; 1.70; 1.71 | — |
| PRIMARY Proportion of Participants Wearing a Hat - NHW - Baseline |
0.20; 0.17; 0.25; 0.27 | — |
| PRIMARY Proportion of Participants Wearing a Hat - NHW - After Intervention |
0.24; 0.29; 0.33; 0.32 | — |
| PRIMARY Seeking Shade - NHW - Baseline |
0.35; 0.27; 0.33; 0.34 | — |
| PRIMARY Seeking Shade - NHW - After Intervention |
0.34; 0.35; 0.35; 0.43 | — |
| PRIMARY Wearing a Shirt - NHW - Baseline |
0.72; 0.70; 0.68; 0.70 | — |
| PRIMARY Wearing a Shirt - NHW - After Intervention |
0.71; 0.72; 0.67; 0.75 | — |
| PRIMARY Wearing Sunglasses - NHW - Baseline |
0.76; 0.75; 0.66; 0.70 | — |
| PRIMARY Wearing Sunglasses - NHW - After Intervention |
0.77; 0.76; 0.70; 0.73 | — |
| PRIMARY Wearing Sunscreen - NHW - Baseline |
0.36; 0.28; 0.36; 0.40 | — |
| PRIMARY Wearing Sunscreen - NHW - After Intervention |
0.36; 0.30; 0.42; 0.38 | — |
| PRIMARY Participants With Indoor Intentional Tanning - NHW - Baseline |
10; 12; 18; 7 | — |
| PRIMARY Participants With Indoor Intentional Tanning - NHW - After Intervention |
4; 9; 15; 7 | — |
| PRIMARY Weekday Sun Exposure - Hispanic Population Baseline |
1.70; 1.60; 1.74; 1.65 | — |
| PRIMARY Weekday Sun Exposure - Hispanic Population After Intervention |
1.38; 1.28; 1.38; 1.45 | — |
| PRIMARY Weekend Sun Exposure - Hispanic Population - Baseline |
2.04; 1.88; 2.05; 1.95 | — |
| PRIMARY Weekend Sun Exposure - Hispanic Population - After Intervention |
1.57; 1.62; 1.67; 1.57 | — |
| PRIMARY Sunburns - Hispanic Population - Baseline |
0.42; 0.52; 0.47; 0.56 | — |
| PRIMARY Sunburns - Hispanic Population - After Intervention |
0.10; 0.15; 0.21; 0.21 | — |
| PRIMARY Outdoor Intentional Tanning - Hispanic Population - Baseline |
1.64; 1.75; 1.64; 1.66 | — |
| PRIMARY Outdoor Intentional Tanning - Hispanic Population - After Intervention |
1.48; 1.49; 1.49; 1.48 | — |
| PRIMARY Proportion of Participants Wearing a Hat - Hispanic Population - Baseline |
0.15; 0.12; 0.25; 0.17 | — |
| PRIMARY Proportion of Participants Wearing a Hat - Hispanic Population - After Intervention |
0.19; 0.17; 0.32; 0.23 | — |
| PRIMARY Seeking Shade - Hispanic Population - Baseline |
0.42; 0.35; 0.43; 0.38 | — |
| PRIMARY Seeking Shade - Hispanic Population - After Intervention |
0.52; 0.46; 0.50; 0.53 | — |
| PRIMARY Wearing a Shirt - Hispanic Population - Baseline |
0.66; 0.65; 0.70; 0.67 | — |
| PRIMARY Wearing a Shirt - Hispanic Population - After Intervention |
0.65; 0.63; 0.68; 0.72 | — |
| PRIMARY Wearing Sunglasses - Hispanic Population - Baseline |
0.52; 0.46; 0.54; 0.51 | — |
| PRIMARY Wearing Sunglasses - Hispanic Population - After Intervention |
0.52; 0.49; 0.54; 0.66 | — |
| PRIMARY Wearing Sunscreen - Hispanic Population - Baseline |
0.24; 0.16; 0.13; 0.15 | — |
| PRIMARY Wearing Sunscreen - Hispanic Population - After Intervention |
0.25; 0.19; 0.13; 0.24 | — |
| PRIMARY Participants With Intentional Indoor Tanning - Hispanic Population - Baseline |
4; 6; 5; 7 | — |
| PRIMARY Participants With Intentional Indoor Tanning - Hispanic Population - After Intervention |
3; 2; 6; 5 | — |
| SECONDARY Weekday Sun Exposure - NHW Children - Baseline |
1.31; 1.50; 1.42; 1.40 | — |
| SECONDARY Weekday Sun Exposure - NHW Children - After Intervention |
1.29; 1.23; 1.34; 1.47 | — |
| SECONDARY Weekend Sun Exposure - NHW Children - Baseline |
2.23; 2.29; 2.33; 2.26 | — |
| SECONDARY Weekend Sun Exposure - NHW Children - After Intervention |
2.36; 2.10; 2.28; 2.24 | — |
| SECONDARY Sunburns - NHW Children - Baseline |
0.31; 0.48; 0.32; 0.37 | — |
| SECONDARY Sunburns - NHW Children - After Intervention |
0.25; 0.16; 0.26; 0.10 | — |
| SECONDARY Outdoor International Tanning - NHW Children - Baseline |
1.09; 1.13; 1.16; 1.10 | — |
| SECONDARY Outdoor Intentional Tanning - NHW Children - After Intervention |
1.06; 0.99; 1.03; 1.06 | — |
| SECONDARY Wearing a Hat - NHW Children - Baseline |
0.24; 0.11; 0.07; 0.09 | — |
| SECONDARY Wearing a Hat - NHW Children - After Intervention |
0.08; 0.02; 0.07; 0.05 | — |
| SECONDARY Seeking Shade - NHW Children - Baseline |
0.12; 0.19; 0.14; 0.15 | — |
| SECONDARY Seeking Shade - NHW Children - After Intervention |
0.49; 0.17; 0.07; 0.18 | — |
| SECONDARY Wearing a Shirt - Average Risk NHW Children - Baseline |
22; 16 | — |
| SECONDARY Wearing a Shirt - Average Risk NHW Children - After Intervention |
25; 21 | — |
| SECONDARY Wearing a Shirt - High Risk NHW Children - Baseline |
0.91; 0.84 | — |
| SECONDARY Wearing a Shirt - High Risk NHW Children - After Intervention |
0.85; 0.96 | — |
| SECONDARY Wearing Sunglasses - Average Risk NHW Children - Baseline |
0.04; 0.04 | — |
| SECONDARY Wearing Sunglasses - Average Risk NHW Children - After Intervention |
0.01; 0.04 | — |
| SECONDARY Wearing Sunglasses -High Risk NHW Children - Baseline |
3; 7 | — |
| SECONDARY Wearing Sunglasses - High Risk NHW Children - After Intervention |
4; 7 | — |
| SECONDARY Wearing Sunscreen - NHW Children - Baseline |
0.71; 0.66; 0.83; 0.88 | — |
| SECONDARY Wearing Sunscreen - NHW Children - After Intervention |
0.70; 0.44; 0.69; 0.86 | — |
| SECONDARY Weekday Sun Exposure - Hispanic Children Population Baseline |
1.48; 1.49; 1.73; 1.53 | — |
| SECONDARY Weekday Sun Exposure - Hispanic Children Population After Intervention |
1.33; 1.04; 2.46; 0.90 | — |
| SECONDARY Weekend Sun Exposure - Hispanic Children Population - Baseline |
1.80; 2.18; 1.87; 1.88 | — |
| SECONDARY Weekend Sun Exposure - Hispanic Children Population - After Intervention |
1.56; 1.48; 2.18; 0.84 | — |
| SECONDARY Sun Protection Behaviors - Hispanic Children Population - Baseline |
1.44; 1.51; 1.50; 1.55 | — |
| SECONDARY Sun Protection Behaviors - Hispanic Children Population - After Intervention |
1.21; 1.68; 1.13; 1.98 | — |
| SECONDARY Outdoor Intentional Tanning - Hispanic Children Population - Baseline |
1.43; 1.39; 1.24; 1.22 | — |
| SECONDARY Outdoor Intentional Tanning - Hispanic Children Population - After Intervention |
0.93; 1.64; 1.35; 1.06 | — |
| SECONDARY Sunburns - Hispanic Children Population - Baseline |
0.53; 0.54; 0.29; 0.20 | — |
| SECONDARY Sunburns - Hispanic Children Population - After Intervention |
0.53; -0.44; 1.21; -0.07 | — |
| SECONDARY Wearing a Hat - Hispanic Children Population - Baseline |
1; 1; 2; 7 | — |
| SECONDARY Wearing a Hat - Hispanic Children Population - After Intervention |
0; 0; 2; 4 | — |
| SECONDARY Seeking Shade - Hispanic Children Population - Baseline |
0.30; 0.16; 0.32; 0.32 | — |
| SECONDARY Seeking Shade - Hispanic Children Population - After Intervention |
0.45; 0.37; 0.52; 0.46 | — |
| SECONDARY Wearing a Shirt - Average Risk Hispanic Children Population - Baseline |
17; 20 | — |
| SECONDARY Wearing a Shirt - Hispanic Children Population - After Intervention |
7; 7 | — |
| SECONDARY Wearing a Shirt - Hispanic Children High Risk Population - Baseline |
0.61; 0.68 | — |
| SECONDARY Wearing a Shirt - Hispanic Children High Risk Population - After Intervention |
0.62; 0.69 | — |
| SECONDARY Wearing Sunglasses - Hispanic Children Population - Baseline |
1; 1; 1; 2 | — |
| SECONDARY Wearing Sunglasses - Hispanic Children Population - After Intervention |
0; 1; 0; 1 | — |
| SECONDARY Wearing Sunscreen - Hispanic Children Average Risk Population - Baseline |
8; 9 | — |
| SECONDARY Wearing Sunscreen - Hispanic Children Population - After Intervention |
2; 3 | — |
| SECONDARY Wearing Sunscreen - Hispanic Children High Risk Population - Baseline |
0.32; 0.39 | — |
| SECONDARY Wearing Sunscreen - Hispanic High Risk Children Population - After Intervention |
0.29; 0.35 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03509467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.