TY - JOUR
T1 - 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
AU - Smit, Amelia K.
AU - Newson, Ainsley J.
AU - Morton, Rachael L.
AU - Kimlin, Michael
AU - Keogh, Louise
AU - Law, Matthew H.
AU - Kirk, Judy
AU - Dobbinson, Suzanne
AU - Kanetsky, Peter A.
AU - Fenton, Georgina
AU - Allen, Martin
AU - Butow, Phyllis
AU - Dunlop, Kate
AU - Trevena, Lyndal
AU - Lo, Serigne
AU - Savard, Jacqueline
AU - Dawkins, Hugh
AU - Wordsworth, Sarah
AU - Jenkins, Mark
AU - Mann, Graham J.
AU - Cust, Anne E.
N1 - Funding Information:
This study is funded by the National Health and Medical Research Council of Australia (NHMRC; project grant 1129822 ). AEC received Career Development Fellowships from the NHMRC ( 1147843 ) and Cancer Institute NSW ( 15/CDF/1-14 ). AKS received a Research Training Program (RTP) Stipend Scholarship and a Merit Top Up Scholarship from the University of Sydney, and a Top Up Scholar Award from the Sydney Catalyst Translational Cancer Research Centre. RLM received funding from an NHMRC Sidney Sax Fellowship ( 1054216 ). MGK is supported through a Cancer Council Queensland Professorial Chair. We thank Professor Bruce Armstrong for initial feedback on the study design. The study has been endorsed by the Australian and New Zealand Melanoma Trials Group, ANZMTG 03.17.
Funding Information:
The Managing Your Risk Study is a two-arm, parallel group randomized controlled trial. The study will be coordinated at The University of Sydney, and study participants will be recruited Australia-wide. This study is funded through a National Health and Medical Research Council (NHMRC) project grant (APP1129822), and has been endorsed by the Australian and New Zealand Melanoma Trials Group (ANZMTG 03.17). Ethical approval has been obtained from the Human Research Ethics Committee at The University of Sydney (2017/163) and this study is prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000691347). This trial protocol has been prepared according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines [ 34 ].
Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2018/7
Y1 - 2018/7
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85047645330&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2018.05.014
DO - 10.1016/j.cct.2018.05.014
M3 - Article
C2 - 29802966
AN - SCOPUS:85047645330
SN - 1551-7144
VL - 70
SP - 106
EP - 116
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -
