National guidelines recommend that older patients with heavy smoking histories get screened each year for lung cancer. Because half of patients eligible for this screening continue to smoke, and because smoking cessation has been shown to help these patients live longer and healthier lives, lung cancer screening programs are required to offer smoking cessation services. However, the best way to help people stop smoking in the context of lung cancer screening is unknown. Importantly, there is very little evidence about how to reduce risks for lung cancer and other tobacco-related illnesses among underserved patients, including those who are black, are Hispanic, live in rural areas, or have low income or education. These patients are particularly likely to smoke and have historically not benefited as much from programs designed to promote quitting.
We propose the largest study to date comparing different ways to help underserved patients who receive lung cancer screening stop smoking. By comparing four different strategies, which differ in the types and number of barriers to quitting that they seek to overcome, the goal of this trial is to understand which interventions work best to help underserved patients quit smoking. This study will also evaluate if different interventions work better for specific groups; for example, for people of different races, ethnicities, incomes, and degrees of tobacco dependence.
This clinical trial will test the effectiveness of four approaches to help patients quit smoking at the time of lung cancer screening. The first group of patients will receive the Ask-Advise-Refer approach, which is a standard approach in which clinicians ask smokers about their desire to quit smoking, advise them to quit, and refer them to resources such as hotlines or smoking cessation classes. The second group will receive Ask-Advise-Refer plus free access to nicotine replacement therapy (e.g., patches and gum) and Food and Drug Administration–approved drugs to help with quitting. The third group will receive Ask-Advise-Refer and free cessation aids, plus a mobile health application that can be completed using texting or internet to help people imagine a future, healthier version of themselves if they quit, as well as the money they would save by doing so. The final group will receive all these approaches and will also get paid money if they successfully quit. Such payments for quitting have been shown in a number of studies to dramatically increase patients’ chances of quitting but have not been tested among patients undergoing lung cancer screening.
This trial will include 3,200 current smokers from underserved groups who are referred for lung cancer screening at four health systems: (1) University of Pennsylvania Health System, (2) Geisinger Health System, (3) Kaiser Permanente South California, and (4) Henry Ford Health System. We will follow all patients for up to 18 months. We will measure if they have stopped using tobacco for six months straight, and also whether the interventions change any of a number of patient-reported factors that our stakeholder partners advised were important to measure, such as quality of life, urge to smoke, motivation to quit, and anxiety. These stakeholders, including patients, doctors, and community leaders, helped design this trial in many other ways, and will continue to be involved throughout this study. Partners will draw from their experiences and networks to drive the study’s success. At the end of this trial, health systems will be able to make better choices about which interventions to include in their lung cancer screening programs to help underserved, high-risk patients quit smoking.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.