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Tobacco Assessment in Actively Accruing National Cancer Institute Clinical Trials Network Trials
Sarah N Price1, Stephanie R Land2, Kinsey Pebley3,4
1Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Introduction:
Tobacco use can adversely affect cancer treatment outcomes, yet routine assessment has not been fully incorporated into oncology clinical trials. In 2012, rates of tobacco use assessment in actively accruing National Cancer Institute (NCI) trials were < 30% at enrollment and < 5% during follow-up, prompting efforts by the NCI and major oncology associations to promote and standardize tobacco assessment in oncology research and practice (including development of the Cancer Patient Tobacco Use Questionnaire [C-TUQ]). This study was conducted to re-examine assessment patterns in 2022 (including utilization of the C-TUQ) and evaluate progress.
Aims And Methods:
Protocols and forms from 144 actively accruing (as of December 2022) NCI National Clinical Trials Network (NCTN) trials were evaluated using a standardized coding instrument.
Results:
Of 144 trials, 49.3% assessed tobacco use at enrollment (43.8% measured cigarettes, 14.8% e-cigarettes, and ≤ 12.5% other tobacco products). Approximately 20.8% used at least one C-TUQ question, but only 3.5% used all four core items. Few measured second-hand smoke exposure (3.5%) or quit interest (2.8%). At follow-up, 8.3% assessed any form of tobacco use. Assessment rates were higher in smoking-related cancer trials.
Conclusions:
Almost half of the accruing trials did not measure any tobacco use and fewer used the C-TUQ. There was a ≥ 70% increase in tobacco use assessment at enrollment and follow-up compared to 2012, an improvement with room for further enhancement. Standardized tobacco use information enhances investigators' ability to estimate cancer treatment efficacy, offer equitable cessation support, and accurately understand the impact of tobacco use on treatment outcomes.
Implications:
In 2012, few (< 30%) cancer clinical trials evaluated tobacco use at enrollment and < 5% did so during follow-up, prompting efforts to promote and standardize tobacco assessment in oncology research and practice (including the development of the Cancer Patient Tobacco Use Questionnaire [C-TUQ]). The present study builds on this foundational paper and finds an overall increase in tobacco use assessment with room for improvement: 49.3% of trials in 2022 assessed tobacco use at enrollment and 8.3% did so during follow-up. About 20.8% used at least one C-TUQ question, highlighting that tobacco use assessment is not yet fully incorporated into oncology clinical trials.
Insights
Tobacco use assessment in cancer clinical trials has increased significantly since 2012, but remains underutilized. Further standardization is needed to improve cancer treatment efficacy and patient support.
Area of Science:
- Oncology
- Clinical Trials
- Public Health
Background:
- Tobacco use negatively impacts cancer treatment outcomes.
- Routine tobacco use assessment in oncology clinical trials has historically been low.
- Initiatives by the National Cancer Institute (NCI) and oncology associations aimed to standardize tobacco assessment.
Purpose of the Study:
- To re-examine tobacco use assessment patterns in NCI National Clinical Trials Network (NCTN) trials in 2022.
- To evaluate the utilization of the Cancer Patient Tobacco Use Questionnaire (C-TUQ).
- To assess progress in tobacco use assessment since 2012.
Main Methods:
- Evaluation of protocols and forms from 144 actively accruing NCTN trials as of December 2022.
- Utilized a standardized coding instrument for data analysis.
Main Results:
- 49.3% of trials assessed tobacco use at enrollment; 8.3% assessed it at follow-up.
- 20.8% of trials used at least one C-TUQ question, with only 3.5% using all core items.
- Assessment rates were higher for smoking-related cancer trials, but few measured secondhand smoke exposure or quit interest.
Conclusions:
- Tobacco use assessment in cancer clinical trials has increased over 70% since 2012 but is not yet fully incorporated.
- Significant room for improvement exists in the routine assessment of tobacco use and related factors in oncology research.
- Standardized tobacco use data is crucial for estimating treatment efficacy, providing cessation support, and understanding tobacco's impact on outcomes.
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