title: Design and methods for a cluster randomized trial of the Sunless Study: a skin cancer prevention intervention promoting sunless tanning among beach visitors.
abstract: BACKGROUND
  Skin cancer is the most prevalent yet most preventable cancer in the US. While protecting oneself from ultraviolet radiation (UVR) can largely reduce risk, rates of unprotected sun exposure remain high. Because the desire to be tan often outweighs health concerns among sunbathers, very few interventions have been successful at reducing sunbathing behavior. Sunless tanning (self-tanners and spray tans), a method of achieving the suntanned look without UVR exposure, might be an effective supplement to prevention interventions.
  
  
  METHODS
  This cluster randomized trial will examine whether a beach-based intervention that promotes sunless tanning as a substitute for sunbathing and includes sun damage imaging and sun safety recommendations is superior to a questionnaire only control group in reducing sunbathing frequency. Female beach visitors (N = 250) will be recruited from 2 public beaches in eastern Massachusetts. Beach site will be the unit of randomization. Follow-up assessment will occur at the end of the summer (1-month following intervention) and 1 year later. The primary outcome is average sunbathing time per week. The study was designed to provide 90% power for detecting a difference of .70 hours between conditions (standard deviation of 2.0) at 1-year with an intra-cluster correlation coefficient of 0.01 and assuming a 25% rate of loss to follow-up. Secondary outcomes include frequency of sunburns, use of sunless tanning products, and sun protection behavior.
  
  
  CONCLUSIONS
  Interventions might be improved by promoting behavioral substitutes for sun exposure, such as sunless tanners, that create a tanned look without exposure to UVR.
  
  
  BACKGROUND
  NCT00403377.
authors.affiliation: Department of Medicine, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, MA, USA. sherry.pagoto@umassmed.edu
authors.forename: Sherry L
authors.initials: SL
authors.lastname: Pagoto
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Schneider
authors.forename: Jessica
authors.initials: J
authors.lastname: Oleski
authors.forename: Jamie S
authors.initials: JS
authors.lastname: Bodenlos
authors.forename: Philip
authors.initials: P
authors.lastname: Merriam
authors.forename: Yunsheng
authors.initials: Y
authors.lastname: Ma
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001294:Attitude to Health; D001493:Bathing Beaches; D016000:Cluster Analysis; D003358:Cosmetics; D005260:Female; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008137:Longitudinal Studies; D008404:Massachusetts; D008875:Middle Aged; D011322:Primary Prevention / Q000379:methods; D012016:Reference Values; D012680:Sensitivity and Specificity; D012878:Skin Neoplasms / Q000517:prevention & control*; D055108:Sunbathing / Q000706:statistics & numerical data; D013472:Sunlight; D055107:Suntan; D055815:Young Adult
chemical_list: D003358:Cosmetics