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
Anne CUST, The University of Sydney, Australia
SMIT A. 1
, KEOGH L. 2
, BUTOW P. 3
, MORTON R. 4
, KIMLIN M. 5
, KIRK J. 6
, LAW M. 7
, DUNLOP K. 8
, DOBBINSON S. 9
, KANETSKY P. 10
, MANN G. 11,12
, NEWSON A. 13
1 Sydney School of Public Health, The University of Sydney, Sydney, Australia
2 Melbourne School of Population and Global Health, The University of Melbourne, Australia
3 Centre for Medical Psychology and Evidence-based Decision-making, School of Psychology, The University of Sydney, Australia
4 NHMRC Clinical Trials Centre, The University of Sydney, Australia
5 The University of the Sunshine Coast and Cancer Council Queensland, Brisbane, Australia
6 Westmead Clinical School and Westmead Institute for Medical Research, Sydney Medical School, The University of Sydney, Australia
7 QIMR Berghofer Medical Research Institute, Brisbane
8 The Centre for Genetics Education, NSW Health, Sydney, Australia
9 Cancer Council Victoria, Melbourne, Australia
10 Cancer Epidemiology Program, Moffitt Cancer Center, Florida, U.S.
11 Centre for Cancer Research, Westmead Institute for Medical Research, The University of Sydney, Australia
12 Melanoma Institute Australia, The University of Sydney, Australia
13 Centre for Values, Ethics and the Law in Medicine, Sydney School of Public Health, The University of Sydney, Australia
Purpose: To evaluate the feasibility and acceptability of giving information on personalised genomic risk of melanoma to the public, and its impact on sun protection and skin examination behaviours, psycho-social and ethical issues.
Methods: We recruited 120 people (22-69 years); consent was 41% overall but differed by age and sex. Participants were randomised 1:1 to the intervention arm (personal genomic risk of melanoma based on variants in 21 genes, delivered as telephone-based genetic counselling and a personalised booklet; plus educational materials) or the waitlist arm (educational materials only, with genomic risk feedback at the end of the study), and followed-up after 3-months (to January 2016).
Results: 118 (98%) participants with complete baseline data were randomised. Most (88%) consented for a copy of their risk information to be sent to their primary care physician. Follow-up questionnaires were completed by 108 (92%) participants and UV dosimeters by 100 (85%). Comments from high-risk participants included that the risk information was “very valuable”, “information I needed to know”, and “reinforces [the] need to be vigilant about sun protection and screening”. One participant elected not to receive their risk information because of insurance concerns. Some participants reported undergoing skin checks as a result of receiving their genomic risk information; analysis is underway to compare the intervention and control groups.
Conclusions: The public expressed a strong interest in receiving their personalised genomic risk information for melanoma. Obtaining saliva samples, questionnaires and UV dosimeters by post, and telephone-based genetic counselling, was feasible and acceptable with minimal loss to follow-up. This pilot will inform a larger trial to evaluate the effectiveness and cost-effectiveness of this innovative melanoma prevention intervention in the general population.
Funding source: Sydney Catalyst Translational Cancer Research Centre, The University of Sydney, Fellowships to AEC from the NHMRC and the Cancer Institute NSW.