Project Summary

PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project and others.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Quitting smoking can help people live longer, healthier lives. Medical guidelines recommend that people in certain age groups who have a history of smoking should get screened for lung cancer. Screening appointments are an opportunity for health systems to offer programs to support patients in quitting smoking.

Many programs help people quit smoking. But these programs may not work equally well for all groups of people. In this study, the research team is comparing combinations of programs to see which approaches help people who are black or Hispanic, people with low levels of education or low incomes, or people who live in rural areas quit smoking. The team is focusing on how well these combinations work when offered at the time of lung cancer screening.

Who can this research help?

The results of this study can help lung cancer screening programs choose the best ways to help patients quit smoking.   

What is the research team doing?

The research team is recruiting 3,200 current smokers who are referred for lung cancer screening at four large health systems. All patients are black or Hispanic, have low incomes, or live in a rural area.

The research team is assigning patients by chance to one of four approaches to encourage them to stop smoking:

  • Ask-Advise-Refer. In this approach, a clinician asks the patient about his or her desire to quit, advises them to quit, and refers the patient to resources such as a quitline.
  • Ask-Advise-Refer plus free prescription medicine to help patients quit and free nicotine patches, gum, and lozenges.
  • The first two ways plus paying people for successfully quitting smoking
  • All of the above ways plus an app that helps people to imagine their future and what life would be like if they didn’t smoke.

The research team is looking at how well each approach helps patients to stop smoking for six months after the date they choose to quit. The team is also comparing how the approaches work for patients of different races, incomes, and communities. The team is also looking at whether patients have successfully avoided smoking 12 and 18 months after their quit date. For the first six months, the team is collecting information from patients three times. The team is asking patients about how motivated they are to quit, how confident they feel about their ability to quit, what might keep them from quitting, and their quality of life.

Patients who have quit smoking, doctors, and community members are helping the research team plan and conduct the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population Current smokers referred for low-dose computed tomography screening for lung cancer who are black or Hispanic, and/or have low socioeconomic status, or live in a rural area 
Interventions/
Comparators
  • Ask-Advise-Refer
  • Ask-Advise-Refer with free prescription medicines and free nicotine patches, gum, and lozenges
  • Ask-Advise-Refer with free prescription medicines and free nicotine patches, gum, and lozenges and financial incentives to successfully quit smoking
  • Ask-Advise-Refer with free prescription medicines and free nicotine patches, gum, and lozenges; financial incentives to successfully quit smoking; and a future thinking application
Outcomes

Primary: tobacco cessation for 6 months

Secondary: relapse rates at 12 and 18 months, self-reported motivation to quit, self-efficacy related to cessation efforts, perceived barriers to cessation, health-related quality of life 

Timeframe 6-month follow-up for primary outcome

Project Information

Scott Halpern, MD, PhD
University of Pennsylvania
$11,542,693
Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening

Key Dates

November 2018
March 2025
2018

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022