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Comparing smoking cessation interventions among underserved patients referred for lung cancer screening
Investigator (PI): Halpern, Scott D
Performing Organization (PO): (Current): University of Pennsylvania, Penn Medicine, Department of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine / (215) 662-2402
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2025
Record Source/Award ID: PCORI/PCS-2018C1-11326
Funding: Total Award Amount: $11,050,783
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: 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 stopping smoking has been shown to help these patients live longer and better, 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, 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 get 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 that can help, such as hotlines or smoking cessation classes. The second group will get Ask-Advise-Refer plus free access to nicotine replacement therapy (e.g., patches and gum) and Food and Drug Administration (FDA)-approved drugs to help with quitting. The third group will get Ask-Advise-Refer, free cessation aids, plus a mobile health application that can be completed using texting or internet on a smartphone 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 of 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 6 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, community leaders, and other partners, 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.
MeSH Terms:
  • Access to Health Care
  • African Americans
  • California
  • Educational Status
  • Food and Drug Administration
  • Hispanic Americans
  • Hotlines
  • Humans
  • Lung Neoplasms /*diagnosis
  • /*prevention & control
  • * Medically Underserved Area
  • Mobile Apps
  • Motivation
  • Nicotine Replacement Products
  • Pennsylvania
  • Quality of Life
  • Rural Population
  • Smoking /*adverse effects
  • Smoking Cessation /*methods
  • Tobacco Use Disorder /*therapy
  • United States
Country: United States
State: Pennsylvania
Zip Code: 19104
UI: 20193323
Project Status: Ongoing