A pilot randomised controlled trial of the feasibility, acceptability and impact of giving information on personalised genomic risk of melanoma to the public.

Smit AK1, Espinoza D2, Newson AJ3, Morton RL2, Fenton G4, Freeman L4, Dunlop K5, Butow PN6, Law MH7, Kimlin MG8, Keogh LA9, Dobbinson SJ10, Kirk J11, Kanetsky PA12, Mann GJ13, Cust AE14.

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Abstract

BACKGROUND:

Communication of personalised melanoma genomic risk information may improve melanoma prevention behaviours.

METHODS:

We evaluated the feasibility and acceptability of communicating personalised genomic risk of melanoma to the public, and its preliminary impact on behaviours and psychosocial outcomes. 118 people aged 22-69 years provided a saliva sample and were randomised to the control (non-personalised educational materials), or intervention (personalised booklet presenting melanoma genomic risk as absolute and relative risks and a risk category based on variants in 21 genes, telephone-based genetic counselling, and non-personalised educational materials). Intention-to-treat analyses overall and by risk category were conducted using ANCOVA adjusted for baseline values.

RESULTS:

Consent to participate was 41%, 99% were successfully genotyped, 92% completed 3-month follow-up. Intervention participants reported high satisfaction with the personalised booklet (mean=8.6, SD=1.6; on a 0-10 scale) and genetic counselling (mean=8.1, SD=2.2). No significant behavioural effects at 3-months follow-up were identified between intervention and control groups overall: objectively-measured standard erythemal doses per day (-16%, 95% confidence interval (CI): -43%, 24%), sun protection index (0.05, 95% CI: -0.07, 0.18). There was increased confidence identifying melanoma at 3-months (0.40, 95% CI: 0.10, 0.69). Stratified by risk category, effect sizes for intentional tanning and some individual sun protection items appeared stronger for the average-risk group. There were no appreciable group differences in skin cancer related worry or psychological distress.