National recommendations for lung cancer screening for former and current smokers aged 55-80 years with a 30-pack-year smoking history create demand to implement efficient and effective systems to offer smoking cessation on a large scale. These older, high-risk smokers differ from participants in past clinical trials of behavioral and pharmacologic interventions for tobacco dependence. There is a gap in knowledge about how best to design systems to extend reach and treatments to maximize smoking cessation in the context of lung cancer screening. Eight clinical trials, seven funded by the National Cancer Institute and one by the Veterans Health Administration, address this gap and form the SCALE (Smoking Cessation within the Context of Lung Cancer Screening) collaboration. This paper describes methodological issues related to the design of these clinical trials: clinical workflow, participant eligibility criteria, screening indication (baseline or annual repeat screen), assessment content, interest in stopping smoking, and treatment delivery method and dose, all of which will affect tobacco treatment outcomes. Tobacco interventions consider the "teachable moment" offered by lung cancer screening, how to incorporate positive and negative screening results, and coordination of smoking cessation treatment with clinical events associated with lung cancer screening. Unique data elements, such as perceived risk of lung cancer and costs of tobacco treatment, are of interest. Lung cancer screening presents a new and promising opportunity to reduce morbidity and mortality resulting from lung cancer that can be amplified by effective smoking cessation treatment. SCALE teamwork and collaboration promise to maximize knowledge gained from the clinical trials.
|Original language||English (US)|
|Number of pages||11|
|Journal||American journal of respiratory and critical care medicine|
|State||Published - Jan 15 2018|
Bibliographical noteFunding Information:
The NCI announced a funding opportunity, SCALE (Smoking Cessation within the Context of Lung Cancer Screening) (R01; RFA-CA-15-011), in June 2015. The goal of the funding opportunity announcement was to support projects testing smoking interventions for patients undergoing LDCT for LCS and to build an evidence base for effective interventions delivered in this setting. Requirements include comparative designs, capacity to determine effective intervention components, common endpoints, measurement of patient acceptance and reach, and cost. NCI is interested in intervention design as well as dissemination and implementation strategies that would be effective in the context of LCS programs. NCI has funded six clinical trials under the funding opportunity announcement as well as an additional trial, and another SCALE trial is funded by the Veterans Health Administration.
Supported by NIH grants R01 CA207078 (P.M.C.), R01 CA207158, R01 CA204222 (C.C.), R01 CA207048 (A.L.G.), R01 CA196873 (A.M.J.), R01 CA207442 and P30CA008748 (J.S.O.), R01 CA207228 (K.L.T.), and R01 CA207229 (B.A.T.), and also by U.S. Department of Veterans Affairs Health Services Research and Development (HSR&D) grant PPO-14-130 and Investigator-Initiated Research (IIR) grant 16-071 (S.B.Z.).
Copyright © 2018 by the American Thoracic Society.
- Clinical trial design
- Lung cancer screening
- Tobacco use cessation