A Randomized Trial of Precision Prevention Materials to Improve Primary and Secondary Melanoma Prevention Activities among Individuals with Limited Melanoma Risk Phenotypes
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Setting and Participants
2.2. Biospecimens and Genotyping
2.3. Randomization and Mailed Prevention Materials
2.4. Study Assessments
2.5. Statistical Analysis
3. Results
3.1. MC1R Average-Risk Participants
3.2. MC1R Higher-Risk Participants
3.3. Children of Participants
3.4. Per Protocol Analyses
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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MC1R Average-Risk, n (%) | MC1R Higher-Risk, n (%) | |||||
---|---|---|---|---|---|---|
Variable | Standard Arm (n = 227) | Precision Prevention Arm (n = 226) | p-Value * | Standard Arm (n = 339) | Precision Prevention Arm (n = 342) | p-Value * |
Participant Characteristics | ||||||
Age (mean, SD) | 48.1 (16.0) | 46.6 (16.8) | 0.34 | 48.5 (15.9) | 47.7 (14.9) | 0.55 |
Female | 112 (49.3) | 116 (51.3) | 0.67 | 175 (51.6) | 168 (49.1) | 0.51 |
Marital status | 0.79 | 0.06 | ||||
Single or never married | 59 (26.0) | 60 (26.5) | 67 (19.8) | 79 (23.1) | ||
Married, domestic partnership, or civil union | 138 (60.8) | 134 (59.3) | 228 (67.3) | 201 (58.8) | ||
Divorced, separated, or widowed | 27 (11.9) | 32 (14.2) | 42 (12.4) | 59 (17.3) | ||
Education | 0.80 | 0.13 | ||||
Graduate degree or higher | 70 (30.8) | 66 (29.2) | 102 (30.1) | 108 (31.6) | ||
Four-year college degree | 55 (24.2) | 61 (27.0) | 109 (32.2) | 122 (35.7) | ||
Some college † | 47 (20.6) | 49 (21.6) | 62 (18.3) | 53 (15.5) | ||
High school or GED | 45 (19.8) | 41 (18.1) | 53 (15.6) | 45 (13.2) | ||
Less than high school or GED | 7 (3.1) | 9 (4.0) | 11 (3.2) | 10 (2.9) | ||
Season at baseline | 0.92 | 0.84 | ||||
Spring | 71 (31.3) | 66 (29.2) | 89 (26.3) | 93 (27.2) | ||
Summer | 39 (17.2) | 38 (16.8) | 60 (17.7) | 63 (18.4) | ||
Fall | 61 (26.9) | 60 (26.5) | 106 (31.3) | 96 (28.1) | ||
Winter | 56 (24.7) | 62 (27.4) | 84 (24.8) | 90 (26.3) | ||
Health literacy | 0.94 | 0.91 | ||||
Extremely confident | 151 (66.5) | 153 (67.7) | 233 (68.7) | 230 (67.3) | ||
Quite a bit confident | 57 (25.1) | 47 (20.8) | 75 (22.1) | 85 (24.9) | ||
Not at all, a little bit, or somewhat confident | 17 (7.5) | 25 (11.1) | 31 (9.1) | 25 (7.3) | ||
Health numeracy | 0.004 | 0.26 | ||||
Very easy | 121 (53.3) | 92 (40.7) | 157 (46.3) | 142 (41.5) | ||
Easy | 91 (40.1) | 110 (48.7) | 163 (48.1) | 178 (52.0) | ||
Hard | 12 (5.3) | 22 (9.7) | 18 (5.3) | 18 (5.3) | ||
Very hard | 1 (0.4) | 1 (0.4) | 0 | 1 (0.3) | ||
Family history of melanoma | 38 (16.7) | 47 (20.8) | 0.28 | 74 (21.8) | 74 (21.6) | 0.94 |
Family history of skin cancer | 68 (30.0) | 61 (27.0) | 0.52 | 97 (28.6) | 99 (28.9) | 0.92 |
Burnability | 0.75 | 0.63 | ||||
Burner | 49 (21.6) | 46 (20.4) | 112 (33.0) | 119 (34.8) | ||
Non-burner | 178 (78.4) | 180 (79.7) | 227 (67.0) | 223 (65.2) | ||
Outcomes | ||||||
Sun exposure (hours) (mean, SD) | ||||||
Weekday | 1.4 (1.3) | 1.4 (1.0) | 0.97 | 1.3 (1.1) | 1.4 (1.3) | 0.15 |
Weekend | 2.3 (1.5) | 2.4 (1.4) | 0.58 | 2.1 (1.4) | 2.4 (1.6) | 0.05 |
Sunburns (mean, SD) | 0.6 (1.0) | 0.7 (1.0) | 0.43 | 0.7 (1.0) | 0.8 (1.1) | 0.23 |
Outdoor intentional tanning (mean, SD) | 1.9 (1.0) | 2.0 (0.9) | 0.48 | 2.0 (1.0) | 2.0 (1.0) | 0.58 |
Indoor tanning | 10 (0.04) | 12 (0.05) | 0.63 | 18 (0.05) | 7 (0.02) | 0.03 |
Wearing a hat often or always | 62 (27.6) | 56 (25.2) | 0.58 | 92 (27.2) | 95 (28.0) | 0.81 |
Seeking shade or using umbrella often or always | 86 (38.2) | 71 (31.8) | 0.16 | 103 (30.5) | 106 (31.2) | 0.84 |
Wearing a shirt with sleeves often or always | 158 (69.9) | 154 (69.1) | 0.84 | 220 (65.1) | 228 (66.9) | 0.63 |
Wearing sunglasses often or always | 161 (71.6) | 153 (68.6) | 0.50 | 217 (64.4) | 233 (68.5) | 0.25 |
Wearing sunscreen often or always | 82 (36.3) | 66 (29.6) | 0.13 | 111 (32.8) | 127 (37.2) | 0.23 |
Standard Arm | Precision Prevention Arm | Intervention Effect * | ||||||
---|---|---|---|---|---|---|---|---|
Outcomes | Baseline | Post-Intervention † | p ‡ | Baseline | Post-Intervention † | p ‡ | Beta/Odds Ratio | p |
MC1R Average-Risk | ||||||||
n = 227 | n = 226 | |||||||
Continuous Outcomes § | ||||||||
Weekday hours | 1.27 | 1.09 | 0.009 | 1.30 | 1.18 | 0.069 | 0.12 | 0.16 |
Weekend hours | 2.17 | 2.00 | 0.067 | 2.25 | 2.08 | 0.031 | 0.11 | 0.18 |
Sunburns | 0.60 | 0.29 | <0.0001 | 0.66 | 0.20 | <0.0001 | -0.07 | 0.35 |
Outdoor intentional tanning | 2.01 | 1.79 | <0.0001 | 2.03 | 1.85 | <0.0001 | 0.06 | 0.48 |
Binary Outcomes ¶ | ||||||||
Wearing a hat often or always | 0.20 | 0.24 | 0.09 | 0.17 | 0.29 | <0.0001 | 1.36 | 0.25 |
Seeking shade or using umbrella often or always | 0.35 | 0.34 | 0.89 | 0.27 | 0.35 | 0.02 | 1.24 | 0.32 |
Wearing a shirt with sleeves often or always | 0.72 | 0.71 | 0.79 | 0.70 | 0.72 | 0.59 | 1.08 | 0.72 |
Wearing sunglasses often or always | 0.76 | 0.77 | 0.61 | 0.75 | 0.76 | 0.57 | 0.91 | 0.72 |
Wearing sunscreen often or always | 0.36 | 0.37 | 0.98 | 0.28 | 0.30 | 0.53 | 0.85 | 0.51 |
Indoor intentional tanning | 0.05 | 0.01 | -- | 0.06 | 0.03 | -- | -- | -- |
MC1R Higher-Risk | ||||||||
n = 339 | n = 342 | |||||||
Continuous Outcomes § | ||||||||
Weekday hours | 1.26 | 1.09 | 0.001 | 1.29 | 1.05 | <0.0001 | 0.01 | 0.74 |
Weekend hours | 2.25 | 1.89 | 0.002 | 2.30 | 1.89 | 0.001 | -0.01 | 0.76 |
Sunburns | 0.83 | 0.27 | <0.0001 | 0.85 | 0.28 | <0.0001 | 0.03 | 0.97 |
Outdoor intentional tanning | 1.96 | 1.70 | <0.0001 | 1.95 | 1.71 | <0.0001 | 0.004 | 0.98 |
Binary Outcomes ¶ | ||||||||
Wearing a hat often or always | 0.25 | 0.33 | 0.001 | 0.27 | 0.32 | 0.03 | 0.87 | 0.53 |
Seeking shade or using umbrella often or always | 0.33 | 0.35 | 0.48 | 0.34 | 0.43 | 0.006 | 1.42 | 0.046 |
Wearing a shirt with sleeves often or always | 0.68 | 0.67 | 0.83 | 0.70 | 0.75 | 0.08 | 1.49 | 0.033 |
Wearing sunglasses often or always | 0.66 | 0.70 | 0.16 | 0.70 | 0.73 | 0.23 | 1.13 | 0.61 |
Wearing sunscreen often or always | 0.36 | 0.42 | 0.10 | 0.40 | 0.38 | 0.44 | 0.83 | 0.39 |
Indoor intentional tanning | 0.06 | 0.03 | -- | 0.02 | 0.01 | -- | -- | -- |
Skin Exam Type | Standard Arm | Precision Prevention Arm | Intervention Effect * | |||||
---|---|---|---|---|---|---|---|---|
n † | Post- Intervention ‡ | n † | Post- Intervention ‡ | Odds Ratio | 95% Confidence Interval | p | ||
MC1R Average-Risk | ||||||||
Health professional | 166 | 0.18 | 169 | 0.17 | 0.90 | 0.51 | 1.60 | 0.72 |
Self/partner | 153 | 0.17 | 148 | 0.19 | 1.17 | 0.64 | 2.11 | 0.61 |
Either | 151 | 0.33 | 144 | 0.34 | 1.02 | 0.62 | 1.69 | 0.94 |
MC1R Higher-Risk | ||||||||
Health professional | 216 | 0.21 | 229 | 0.21 | 0.96 | 0.60 | 1.52 | 0.86 |
Self/partner | 202 | 0.28 | 211 | 0.23 | 0.76 | 0.49 | 1.20 | 0.24 |
Either | 199 | 0.37 | 202 | 0.38 | 1.01 | 0.66 | 1.53 | 0.98 |
Outcome | Moderator | Intervention Effect | Intervention Effect P | Moderation P |
---|---|---|---|---|
MC1R Average-Risk | ||||
Weekend Hours | Marital status | 0.019 | ||
Single, separated, divorced, or widowed | −0.15 | 0.34 | ||
Married, domestic partnership, or civil union | 0.32 | 0.01 | ||
Sunburns | Family history of non-melanoma skin cancer | 0.049 | ||
No | −0.10 | 0.07 | ||
Yes | 0.09 | 0.23 | ||
Wearing a hat often or always | Family history of melanoma | 0.030 | ||
No | 1.05 * | 0.87 | ||
Yes | 5.23 * | 0.01 | ||
Seeking shade or using umbrella often or always | Family history of melanoma | 0.023 | ||
No | 0.98 * | 0.93 | ||
Yes | 3.67 * | 0.01 | ||
MC1R Higher-Risk | ||||
Sunburns | Tendency to burn | 0.032 | ||
Burners | −0.14 | 0.09 | ||
Non-burners | 0.07 | 0.16 |
Standard Arm | Precision Prevention Arm | Intervention Effect * | ||||||
---|---|---|---|---|---|---|---|---|
Outcomes | Baseline | Post-Intervention † | p ‡ | Baseline | Post-Intervention † | p ‡ | Beta | p |
MC1R Average-Risk | ||||||||
n = 25 | n = 21 | |||||||
Continuous Outcomes § | ||||||||
Weekday hours | 1.31 | 1.29 | 0.91 | 1.50 | 1.23 | 0.21 | −0.06 | 0.87 |
Weekend hours | 2.23 | 2.36 | 0.42 | 2.29 | 2.10 | 0.35 | −0.24 | 0.41 |
Sunburns | 0.31 | 0.25 | 0.33 | 0.48 | 0.16 | 0.12 | −0.20 | 0.77 |
Outdoor intentional tanning | 1.09 | 1.06 | 0.77 | 1.13 | 0.99 | 0.27 | 0.09 | 0.42 |
Binary Outcomes ¶ | ||||||||
Wearing a hat often or always ** | 0.24 | 0.08 | 0.26 | 0.11 | 0.02 | 0.19 | 0.17 | 0.08 |
Seeking shade or using umbrella often or always | 0.12 | 0.49 | 0.15 | 0.19 | 0.17 | 0.87 | 0.60 | 0.78 |
Wearing a shirt with sleeves often or always †† | 0.85 | 0.88 | -- | 0.69 | 1.00 | -- | -- | -- |
Wearing sunglasses often or always ** | 0.04 | 0.02 | 0.34 | 0.04 | 0.04 | 0.93 | 1.59 | 0.81 |
Wearing sunscreen often or always | 0.71 | 0.70 | 0.78 | 0.66 | 0.44 | 0.43 | 0.29 | 0.24 |
MC1R Higher-Risk | ||||||||
n = 49 | n = 46 | |||||||
Continuous Outcomes § | ||||||||
Weekday hours | 1.42 | 1.34 | 0.59 | 1.40 | 1.47 | 0.61 | 0.03 | 0.38 |
Weekend hours | 2.33 | 2.28 | 0.77 | 2.26 | 2.24 | 0.89 | 0.10 | 0.76 |
Sunburns | 0.32 | 0.26 | 0.33 | 0.37 | 0.10 | 0.01 | −0.13 | 0.03 |
Outdoor intentional tanning | 1.16 | 1.03 | 0.02 | 1.10 | 1.06 | 0.20 | 0.01 | 0.78 |
Binary Outcomes ¶ | ||||||||
Wearing a hat often or always ** | 0.07 | 0.07 | 0.93 | 0.09 | 0.05 | 0.41 | 0.88 | 0.87 |
Seeking shade or using umbrella often or always | 0.14 | 0.07 | 0.24 | 0.15 | 0.18 | 0.99 | 2.53 | 0.10 |
Wearing a shirt with sleeves often or always | 0.91 | 0.84 | 0.41 | 0.84 | 0.96 | 0.05 | 2.45 | 0.13 |
Wearing sunglasses often or always †† | 0.07 | 0.06 | -- | 0.11 | 0.12 | -- | -- | -- |
Wearing sunscreen often or always | 0.83 | 0.69 | 0.21 | 0.88 | 0.86 | 0.79 | 2.65 | 0.06 |
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Lacson, J.C.A.; Doyle, S.H.; Qian, L.; Del Rio, J.; Forgas, S.M.; Valavanis, S.; Carvajal, R.; Gonzalez-Calderon, G.; Kim, Y.; Roetzheim, R.G.; et al. A Randomized Trial of Precision Prevention Materials to Improve Primary and Secondary Melanoma Prevention Activities among Individuals with Limited Melanoma Risk Phenotypes. Cancers 2021, 13, 3143. https://doi.org/10.3390/cancers13133143
Lacson JCA, Doyle SH, Qian L, Del Rio J, Forgas SM, Valavanis S, Carvajal R, Gonzalez-Calderon G, Kim Y, Roetzheim RG, et al. A Randomized Trial of Precision Prevention Materials to Improve Primary and Secondary Melanoma Prevention Activities among Individuals with Limited Melanoma Risk Phenotypes. Cancers. 2021; 13(13):3143. https://doi.org/10.3390/cancers13133143
Chicago/Turabian StyleLacson, John Charles A., Scarlet H. Doyle, Lu Qian, Jocelyn Del Rio, Stephanie M. Forgas, Stella Valavanis, Rodrigo Carvajal, Guillermo Gonzalez-Calderon, Youngchul Kim, Richard G. Roetzheim, and et al. 2021. "A Randomized Trial of Precision Prevention Materials to Improve Primary and Secondary Melanoma Prevention Activities among Individuals with Limited Melanoma Risk Phenotypes" Cancers 13, no. 13: 3143. https://doi.org/10.3390/cancers13133143