title: Chemoprevention Trial Feasibility Using Botanicals in Exceptionally High Risk Populations for Lung Cancer.
abstract: While chemoprevention with botanicals shows promise in reducing cancer risk, recruitment and retention of participants for trials continues to be costly and presents unique challenges. Knowledge of interest, willingness of target populations and evaluation of design challenges are critical to improve accrual in these chemoprevention trials.
  
  
  OBJECTIVE
  The study assessed interest and willingness of former smokers to participate in a chemoprevention trial using a botanical agent.
  
  
  METHODS
  An introductory letter and survey instrument were mailed to 609 consecutive, former heavy smokers, with no cancer, from a database of 826 subjects at the Moffitt Cancer Center.
  
  
  RESULTS
  202 (40.4%) subjects returned completed surveys. 92-96% reported interest in receiving free lung exams and knowing their lung cancer risk. 88% were interested in participating in a trial evaluating a botanical agent for lung cancer prevention. Over 92% of subjects reported willingness to comply with study requirements; multiple blood draws and trips to the Center, spiral CTs and chest x-rays. Subjects were relatively less enthusiastic (73-79%) about bronchoscopy, taking multiple study agents and assignment to placebo arm.
  
  
  CONCLUSIONS
  Our study strongly suggests feasibility, highlights potential challenges and the significant interest and willingness of this exceptionally high risk population to participate in chemoprevention trials.
authors.affiliation: Departments of Epidemiology, University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: Nagi B
authors.initials: NB
authors.lastname: Kumar
authors.affiliation: Health Outcomes and Behavior, University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: Gwendolyn P
authors.initials: GP
authors.lastname: Quinn
authors.affiliation: Molecular Oncology Thoracic Oncology, University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: Mark G
authors.initials: MG
authors.lastname: Alexandrow
authors.affiliation: Biostatistics, University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: Jhanelle
authors.initials: J
authors.lastname: Gray
authors.affiliation: H Lee Moffitt Cancer Center & Research Institute, the University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Schell
authors.affiliation: H Lee Moffitt Cancer Center & Research Institute, the University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: Steve
authors.initials: S
authors.lastname: Sutton
authors.affiliation: Biostatistics, University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: Eric B
authors.initials: EB
authors.lastname: Haura
keywords: Chemoprevention; Former smokers; Lung Cancer