title: Breast cancer prevention in community clinics: will low-income Latina patients participate in clinical trials?
abstract: BACKGROUND
  Latinas have low rates of participation in breast cancer prevention trials. We evaluated the feasibility and effectiveness of a randomized trial of brief counseling and print materials compared to print materials alone to increase intent to participate in a breast cancer prevention trial.
  
  
  METHODS
  We enrolled 450 women Spanish-speaking women from three urban community primary care clinics. The outcome was intent, defined as might, probably, or definitely would enroll in the trial. We also examined results using a more stringent definition restricted to probably and definitely intend to participate.
  
  
  RESULTS
  The trial was feasible within these busy clinics, and 96% of women agreed to participate. The level of breast cancer knowledge was fairly high (66% correct answers), but understanding about clinical trials was lower (40.5% correct answers). Using the less stringent criteria for intent, 72% of women stated that they intended to enroll in the STAR trial if eligible, but rates of intent decreased to 52% with framing that included medication side effects and 45% if uterine cancer was mentioned (P < 0.01 for trend). Using the more stringent definition, slightly fewer than half of the women indicated an interest in participating, with the same trend towards decreasing intent with increasing presentation of side effects. The intervention was only effective using the less stringent definition and if no side effects were mentioned (77% intent vs. 67% in the intervention and control groups, respectively, P = 0.03). Intention was independently associated with greater worry about breast cancer and younger age, but not acculturation or knowledge.
  
  
  CONCLUSIONS
  Latina women are interested in participating in clinical trials to prevent breast cancer, although interest declines with increasing discussion of side effects. Unfortunately, brief education only increased rates of intention using the least stringent definition and when no side effects were presented in framing the question. Future work should focus on qualitative research to understand the theoretical foundations of preventive health behaviors in this population.
authors.affiliation: Department of Oncology, Cancer Control Program, Lombardi Cancer Center, Georgetown University, Washington, DC 20007-4104, USA. mandelbj@georgetown.edu
authors.forename: Jeanne
authors.initials: J
authors.lastname: Mandelblatt
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Kaufman
authors.forename: Vanessa B
authors.initials: VB
authors.lastname: Sheppard
authors.forename: Jyl
authors.initials: J
authors.lastname: Pomeroy
authors.forename: John
authors.initials: J
authors.lastname: Kavanaugh
authors.forename: Janet
authors.initials: J
authors.lastname: Canar
authors.forename: Laura
authors.initials: L
authors.lastname: Pallandre
authors.forename: Jennifer
authors.initials: J
authors.lastname: Cullen
authors.forename: Elmer
authors.initials: E
authors.lastname: Huerta
mesh_terms: D000328:Adult; D001294:Attitude to Health / Q000208:ethnology*; D001943:Breast Neoplasms / Q000208:ethnology / Q000517:prevention & control*; D002986:Clinical Trials as Topic; D003151:Community Health Centers; D004219:District of Columbia; D004522:Educational Status; D005260:Female; D006266:Health Education / Q000379:methods*; D006630:Hispanic or Latino / Q000193:education* / Q000523:psychology / Q000706:statistics & numerical data; D006801:Humans; D008403:Mass Screening / Q000379:methods* / Q000706:statistics & numerical data; D008875:Middle Aged; D018579:Patient Selection; D011203:Poverty; D011336:Probability; D012016:Reference Values; D012680:Sensitivity and Specificity; D012959:Socioeconomic Factors; D013664:Teaching Materials; D016387:Women's Health / Q000208:ethnology