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Contemp Clin Trials. 2018 Jul;70:106-116. doi: 10.1016/j.cct.2018.05.014. Epub 2018 May 23.

The melanoma genomics managing your risk study: A protocol for a randomized controlled trial evaluating the impact of personal genomic risk information on skin cancer prevention behaviors.

Author information

1
Cancer Epidemiology and Prevention Research, Sydney School of Public Health, The University of Sydney, NSW 2006, Australia; Sydney Health Ethics, Sydney School of Public Health, The University of Sydney, NSW 2006, Australia; Melanoma Institute Australia, The University of Sydney, NSW 2006, Australia. Electronic address: amelia.smit@sydney.edu.au.
2
Sydney Health Ethics, Sydney School of Public Health, The University of Sydney, NSW 2006, Australia.
3
NHMRC Clinical Trials Centre, The University of Sydney, NSW 2006, Australia.
4
University of the Sunshine Coast and Cancer Council Queensland, PO Box 201, Spring Hill, QLD 4004, Australia.
5
Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC 3010, Australia.
6
Statistical Genetics, QIMR Berghofer Medical Research Institute, Locked Bag 2000, Brisbane, QLD 4029, Australia.
7
Westmead Clinical School and Westmead Institute for Medical Research, Sydney Medical School, The University of Sydney, NSW 2006, Australia.
8
Cancer Council Victoria, 615 St Kilda Road, Melbourne, VIC 3004, Australia.
9
H. Lee Moffitt Cancer Center and Research Institute and University of South Florida, 4202 E Fowler Ave, Tampa, FL 33620, USA.
10
Cancer Epidemiology and Prevention Research, Sydney School of Public Health, The University of Sydney, NSW 2006, Australia.
11
Electrical and Computer Engineering, University of Canterbury, Private Bag 4800, Christchurch 8140, New Zealand.
12
Centre for Medical Psychology and Evidence-based Decision-making, School of Psychology, The University of Sydney, NSW 2006, Australia.
13
The Centre for Genetics Education, NSW Health, Level 5 2c Herbert Street St Leonards, NSW 2065, Australia.
14
Sydney School of Public Health, The University of Sydney, NSW 2006, Australia.
15
Melanoma Institute Australia, The University of Sydney, NSW 2006, Australia.
16
Office of Population Health Genomics, Public Health Division, Government of Western Australia, Level 3 C Block 189 Royal Street, East Perth, WA 6004, Australia.
17
Health Economics Research Centre, The University of Oxford, Oxford OX1 2JD, UK.
18
Centre for Epidemiology & Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC 3010, Australia.
19
Melanoma Institute Australia, The University of Sydney, NSW 2006, Australia; Centre for Cancer Research, Westmead Institute for Medical Research, The University of Sydney, NSW 2006, Australia.
20
Cancer Epidemiology and Prevention Research, Sydney School of Public Health, The University of Sydney, NSW 2006, Australia; Melanoma Institute Australia, The University of Sydney, NSW 2006, Australia.

Abstract

BACKGROUND:

Reducing ultraviolet radiation (UV) exposure and improving early detection may reduce melanoma incidence, mortality and health system costs. This study aims to evaluate the efficacy and cost-effectiveness of providing information on personal genomic risk of melanoma in reducing UV exposure at 12 months, according to low and high traditional risk.

METHODS:

In this randomized controlled trial, participants (target sample = 892) will be recruited from the general population, and randomized (1:1 ratio, intervention versus control). Intervention arm participants provide a saliva sample, receive personalized melanoma genomic risk information, a genetic counselor phone call, and an educational booklet on melanoma prevention. Control arm participants receive only the educational booklet. Eligible participants are aged 18-69 years, have European ancestry and no personal history of melanoma. All participants will complete a questionnaire and wear a UV dosimeter to objectively measure their sun exposure at baseline, 1- and 12-month time-points, except 1-month UV dosimetry will be limited to ~250 participants. The primary outcome is total daily Standard Erythemal Doses at 12 months. Secondary outcomes include objectively measured UV exposure for specific time periods (e.g. midday hours), self-reported sun protection and skin-examination behaviors, psycho-social outcomes, and ethical considerations surrounding offering genomic testing at a population level. A within-trial and modelled economic evaluation will be undertaken from an Australian health system perspective to assess the intervention costs and outcomes.

DISCUSSION:

This trial will inform the clinical and personal utility of introducing genomic testing into the health system for melanoma prevention and early detection at a population-level.

TRIAL REGISTRATION:

Australian New Zealand Clinical Trials Registry ACTRN12617000691347.

KEYWORDS:

Behavior change; Cost-benefit analysis; Genomic risk; Melanoma; Prevention; Randomized controlled trial

PMID:
29802966
DOI:
10.1016/j.cct.2018.05.014

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