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 Sith; Ainsley J Newson; Rachael L Morton; Michael G Kimlin; Louise Keogh; Matthew H Law; Judy Kirk; Suzanne Dobbinson; Peter A Kanetsky; Georgina Fenton; Martin Allen; Phyllis Butow; Kate Dunlop; Lyndal Trevena; Serigne Lo; Jacqueline Savard; Hugh Dawkins; Sarah Wordsworth; Mark Jenkins; Graham J Mann; Anne E Cust

doi:10.1016/j.cct.2018.05.014

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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

Journal article

Open access

Peer reviewed

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 Sith, Ainsley J Newson, Rachael L Morton, Michael G Kimlin, Louise Keogh, Matthew H Law, Judy Kirk, Suzanne Dobbinson, Peter A Kanetsky, Georgina Fenton, …

Contemporary Clinical Trials, Vol.70, pp.106-116

2018

DOI: https://doi.org/10.1016/j.cct.2018.05.014

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Abstract

melanoma

genomic risk

behavior change

prevention

cost-benefit analysis

randomized controlled trial

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 = 1192) 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 measured in ~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.

Details

Title: 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: Amelia K Sith (Author) - University of Sydney
Ainsley J Newson (Author) - University of Sydney
Rachael L Morton (Author) - University of Sydney
Michael G Kimlin (Author) - University of the Sunshine Coast - Faculty of Science, Health, Education and Engineering
Louise Keogh (Author) - University of Melbourne
Matthew H Law (Author) - QIMR Berghofer Medical Institute
Judy Kirk (Author) - University of Sydney
Suzanne Dobbinson (Author) - Cancer Council Victoria
Peter A Kanetsky (Author) - University of South Florida, United States
Georgina Fenton (Author) - University of Sydney
Martin Allen (Author) - University of Canterbury, New Zealand
Phyllis Butow (Author) - University of Sydney
Kate Dunlop (Author) - New South Wales Health
Lyndal Trevena (Author) - University of Sydney
Serigne Lo (Author) - University of Sydney
Jacqueline Savard (Author) - University of Sydney
Hugh Dawkins (Author) - Western Australian Office of Population Health Genomics
Sarah Wordsworth (Author) - University of Oxford, United Kingdom
Mark Jenkins (Author) - University of Melbourne
Graham J Mann (Author) - University of Sydney
Anne E Cust (Author) - University of Sydney
Publication details: Contemporary Clinical Trials, Vol.70, pp.106-116
Publisher: Elsevier Inc.
Date published: 2018
DOI: 10.1016/j.cct.2018.05.014
ISSN: 1551-7144
Organisation Unit: University of the Sunshine Coast, Queensland; School of Health and Sport Sciences - Legacy
Language: English
Record Identifier: 99450431202621
Output Type: Journal article

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Web Of Science research areas: Medicine, Research & Experimental; Pharmacology & Pharmacy

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