title: A Pilot Randomized Controlled Trial of the Feasibility, Acceptability, and Impact of Giving Information on Personalized Genomic Risk of Melanoma to the Public.
abstract: Communication of personalized melanoma genomic risk information may improve melanoma prevention behaviors.
  
  
  
  We evaluated the feasibility and acceptability of communicating personalized genomic risk of melanoma to the public and its preliminary impact on behaviors and psychosocial outcomes. One hundred eighteen people aged 22 to 69 years provided a saliva sample and were randomized to the control (nonpersonalized educational materials) or intervention (personalized booklet presenting melanoma genomic risk as absolute and relative risks and a risk category based on variants in 21 genes, telephone-based genetic counseling, and nonpersonalized educational materials). Intention-to-treat analyses overall and by-risk category were conducted using ANCOVA adjusted for baseline values.
  
  
  
  Consent to participate was 41%, 99% were successfully genotyped, and 92% completed 3-month follow-up. Intervention participants reported high satisfaction with the personalized booklet (mean = 8.6, SD = 1.6; on a 0-10 scale) and genetic counseling (mean = 8.1, SD = 2.2). No significant behavioral effects at 3-month follow-up were identified between intervention and control groups overall: objectively measured standard erythemal doses per day [-16%; 95% confidence interval (CI), -43% to 24%] and sun protection index (0.05; 95% CI, -0.07 to 0.18). There was increased confidence identifying melanoma at 3 months (0.40; 95% CI, 0.10-0.69). Stratified by risk category, effect sizes for intentional tanning and some individual sun protection items appeared stronger for the average-risk group. There were no appreciable group differences in skin cancer-related worry or psychologic distress.
  
  
  
  Our results demonstrate feasibility and acceptability of providing personalized genomic risk of melanoma to the public.
  
  
  
  Genomic risk information has potential as a melanoma prevention strategy. Cancer Epidemiol Biomarkers Prev; 26(2); 212-21. ©2016 AACR.
authors.affiliation: Cancer Epidemiology and Prevention Research, Sydney School of Public Health, The University of Sydney, Australia.
authors.forename: Amelia K
authors.initials: AK
authors.lastname: Smit
authors.affiliation: NHMRC Clinical Trials Centre, The University of Sydney, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Espinoza
authors.affiliation: Centre for Values, Ethics and the Law in Medicine, Sydney School of Public Health, The University of Sydney, Australia.
authors.forename: Ainsley J
authors.initials: AJ
authors.lastname: Newson
authors.affiliation: NHMRC Clinical Trials Centre, The University of Sydney, Australia.
authors.forename: Rachael L
authors.initials: RL
authors.lastname: Morton
authors.affiliation: Cancer Epidemiology and Prevention Research, Sydney School of Public Health, The University of Sydney, Australia.|The Centre for Genetics Education, NSW Health, Sydney, Australia.
authors.forename: Georgina
authors.initials: G
authors.lastname: Fenton
authors.affiliation: Cancer Epidemiology and Prevention Research, Sydney School of Public Health, The University of Sydney, Australia.|The Centre for Genetics Education, NSW Health, Sydney, Australia.
authors.forename: Lucinda
authors.initials: L
authors.lastname: Freeman
authors.affiliation: The Centre for Genetics Education, NSW Health, Sydney, Australia.
authors.forename: Kate
authors.initials: K
authors.lastname: Dunlop
authors.affiliation: Centre for Medical Psychology and Evidence-based Decision-making, School of Psychology, The University of Sydney, Australia.
authors.forename: Phyllis N
authors.initials: PN
authors.lastname: Butow
authors.affiliation: Statistical Genetics, QIMR Berghofer Medical Research Institute, Brisbane, Australia.
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Law
authors.affiliation: The University of the Sunshine Coast and Cancer Council Queensland, Brisbane, Australia.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Kimlin
authors.affiliation: Melbourne School of Population and Global Health, The University of Melbourne, Australia.
authors.forename: Louise A
authors.initials: LA
authors.lastname: Keogh
authors.affiliation: Cancer Council Victoria, Melbourne, Australia.
authors.forename: Suzanne J
authors.initials: SJ
authors.lastname: Dobbinson
authors.affiliation: Westmead Clinical School, and Westmead Institute for Medical Research, Sydney Medical School, The University of Sydney, Australia.
authors.forename: Judy
authors.initials: J
authors.lastname: Kirk
authors.affiliation: Cancer Epidemiology Program, Moffitt Cancer Center, Tampa, Florida.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Kanetsky
authors.affiliation: Centre for Cancer Research, Westmead Institute for Medical Research, The University of Sydney, Australia.|Melanoma Institute Australia, The University of Sydney, Australia.
authors.forename: Graham J
authors.initials: GJ
authors.lastname: Mann
authors.affiliation: Cancer Epidemiology and Prevention Research, Sydney School of Public Health, The University of Sydney, Australia. anne.cust@sydney.edu.au.|Melanoma Institute Australia, The University of Sydney, Australia.
authors.forename: Anne E
authors.initials: AE
authors.lastname: Cust
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005817:Genetic Counseling / Q000379:methods*; D020022:Genetic Predisposition to Disease; D005820:Genetic Testing / Q000379:methods*; D006801:Humans; D007258:Informed Consent; D008297:Male; D008545:Melanoma / Q000453:epidemiology / Q000235:genetics / Q000517:prevention & control*; D008875:Middle Aged; D009517:New South Wales / Q000453:epidemiology; D010353:Patient Education as Topic; D010865:Pilot Projects; D012189:Retrospective Studies; D012307:Risk Factors; D012878:Skin Neoplasms / Q000453:epidemiology / Q000235:genetics / Q000517:prevention & control*; D055815:Young Adult