A Pilot Randomised Controlled Trial Examining The Feasibility, Acceptability And Impact Of Giving Information On Personalised Genomic Risk Of Melanoma To The Public, For Motivating Preventive Behaviours

1556 Background: Melanoma is highly preventable. We aimed to evaluate the feasibility and acceptability of giving information on personalised genomic risk of melanoma to the public, and its impact on behaviours, psychosocial and ethical issues. Methods: We recruited 120 people (22-69 years); consent was 41% overall but differed by age and sex. Participants were randomised to the intervention (personal genomic risk of melanoma based on variants in 21 genes, with a personalised booklet and telephone-based genetic counselling; plus educational materials) or the waitlist control (educational materials only). Follow-up was conducted after 3-months. Results: 118 (98%) completed baseline data and were randomised (intervention=60; control=58). Follow-up questionnaires were completed by 108 (92%) participants and 4-day objective UV measures by 101 (86%). Intervention participants reported high satisfaction with the risk booklet (mean 8.6, SD 1.6) and genetic counselling (mean 8.1, SD 2.2) on a 0-10 scale. Preliminary outcomes at 3-months suggest there were some beneficial changes to preventive behaviours, particularly in the high- and average-risk groups, but most were not statistically significant (Table). There were no consistent differences in psychosocial outcomes between the study groups. Conclusions: Results from this pilot study demonstrate the feasibility and acceptability of giving information on personalised genomic risk of melanoma to the public. A larger trial with longer follow-up is needed to evaluate effectiveness and cost-effectiveness. Clinical trial information: 12615000356561. Between-group mean difference (95% CI) at 3-months1, stratified by genomic risk High Average Low Peak-sun hr/wk (0-28) -0.74 (-3.53, 2.06) -0.96 (-2.72, 0.81) -1.71 (-5.20, 1.78) Intentional tanning (1never -5always ) -0.33 (-0.80, 0.14) -0.38 (-0.66, -0.10)2 0.12 (-0.44, 0.67) Sun protection3 (1never -4always ) -0.10 (-0.36, 0.16) 0.17 (-0.02, 0.36) 0.01 (-0.25, 0.26) 1 Presented as adjusted means from ANCOVA for continuous variables; with 95% confidence intervals (CI) and adjusted for baseline values. 2 P<0.01 3 Index based on 6 behaviours