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

Amelia K Smit¹, Ainsley J Newson², Rachael L Morton³, Michael Kimlin⁴, Louise Keogh⁵, Matthew H Law⁶, Judy Kirk⁷, Suzanne Dobbinson⁸, Peter A Kanetsky⁹, Georgina Fenton¹⁰, Martin Allen¹¹, Phyllis Butow¹², Kate Dunlop¹³, Lyndal Trevena¹⁴, Serigne Lo¹⁵, Jacqueline Savard², Hugh Dawkins¹⁶, Sarah Wordsworth¹⁷, Mark Jenkins¹⁸, Graham J Mann¹⁹, Anne E Cust²⁰

Affiliations

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.

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

Randomized Controlled Trial

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

Amelia K Smit et al. Contemp Clin Trials. 2018 Jul.

. 2018 Jul:70:106-116.

doi: 10.1016/j.cct.2018.05.014. Epub 2018 May 23.

Authors

Affiliations

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.

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

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.

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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

Affiliations

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

Authors

Affiliations

Abstract

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Miscellaneous