NCI-Funded Clinical Trials Fail to Assess Tobacco Use

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(ChemotherapyAdvisor) – Actively accruing National Cancer Institute–funded Cooperative Group clinical trials do not incorporate standardized tobacco assessments, ultimately limiting the ability not only to provide evidence-based cessation support but the ability to understand the precise effect of tobacco use on cancer treatment outcomes, investigators reported in the Journal of Clinical Oncology online June 11.

Moreover, “there is no observable trend in improvement over the past eight years,” they found in a review of 155 activity accruing trials. Of the trials, 45 (29%) assessed any form of tobacco use at enrollment, 34 (21.9%) assessed current cigarette use, and 7 (4.5%) assessed any form of tobacco use during follow-up.

“Secondhand smoke exposure was captured in 2.6% of trials at enrollment and 0.6% during follow-up,” they found. “None of the trials assessed nicotine dependence or interest in quitting at any point during enrollment or treatment.”

Assessment of tobacco status was higher in lung, head and neck, and Phase 3 trials; however, no difference according to year of starting accrual or cooperative group was observed.

“Oncology research and patients enrolled in research trials may benefit from comprehensive assessment of tobacco status and subsequent increased knowledge about the effects of tobacco on treatment outcome,” the investigators wrote. “Implementing structured tobacco assessments into clinical trials design will improve the understanding of the effects of tobacco use on treatment outcomes and may directly improve health outcomes in patients with cancer enrolled onto clinical trials.”


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