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Nicotine & Tobacco Research Advance Access originally published online on October 6, 2009
Nicotine & Tobacco Research 2009 11(11):1354-1358; doi:10.1093/ntr/ntp145
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© The Author 2009. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org

Who's assessing tobacco use in cancer clinical trials?

David I. Gregorio, Morgan Hollenbeck and Holly Samociuk

David I. Gregorio, Ph.D., M.S., Department of Community Medicine & Health Care, University of Connecticut School of Medicine, Farmington
Morgan Hollenbeck, M.P.H., Department of Community Medicine & Health Care, University of Connecticut School of Medicine, Farmington
Holly Samociuk, B.A., Department of Community Medicine & Health Care, University of Connecticut School of Medicine, Farmington

Corresponding Author: David I. Gregorio, Ph.D., M.S., Department of Community Medicine & Health Care, University of Connecticut, 263 Farmington Avenue, Farmington, CT 06030-6325; Telephone: 860-679-5480; Fax: 860-679-5464; E-mail: gregorio{at}nso.uchc.edu


  Abstract

Introduction: Clinical trials that do not collect data on tobacco use/exposure may not adequately assess the efficacy and effectiveness of experimental treatments.

Methods: A cross-sectional study of interventional trials cited on ClinicalTrials.gov was undertaken that inquired of Local Project Directors from Connecticut guiding studies of breast, prostate, or colorectal cancer chemotherapy (N = 68) whether their protocols measured tobacco use by trial participants. Information pertaining to 46 trials (68%) is reported here. All but 1 were multicentered trials enrolling patients around the country.

Results: Only 3 trials (7%) reported routine collection of tobacco use information at baseline and no trial reported monitoring tobacco use during treatment follow-up. None of the 3 trials collecting tobacco data reported using exposure information in analysis of treatment effects. Survey respondents suggested that uncertainty about the relevance of tobacco exposure to therapeutic efficacy, ambivalence about how to incorporate such data into analyses, insufficient resources for collecting such information, and uncertainty about the validity of assessment methods might be reasons why tobacco use is not routinely assessed.

Discussion: Additional studies that address a fuller range of cancers, therapies, disease states, and clinical environments are needed to fully define the extent of this data lapse. Providing clinicians and trialists with appropriate tools for tobacco use assessment and encouraging them to collect such information about patients during treatment and follow-up may offer a simple cost-effective way to improve the quality and consequences of cancer care for every patient.

Received: February 27, 2009; Accepted: July 29, 2009
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