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J Clin Trials. 2014 Sep;4(4). pii: 180.

Chemoprevention Trial Feasibility Using Botanicals in Exceptionally High Risk Populations for Lung Cancer.

Author information

1
Departments of Epidemiology, University of South Florida College of Medicine, Tampa, Florida, USA.
2
Health Outcomes and Behavior, University of South Florida College of Medicine, Tampa, Florida, USA.
3
Molecular Oncology Thoracic Oncology, University of South Florida College of Medicine, Tampa, Florida, USA.
4
Biostatistics, University of South Florida College of Medicine, Tampa, Florida, USA.
5
H Lee Moffitt Cancer Center & Research Institute, the University of South Florida College of Medicine, Tampa, Florida, USA.

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.

KEYWORDS:

Chemoprevention; Former smokers; Lung Cancer

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