Smoking Cessation Interventions for Lung Cancer Screening Patients

No longer recruiting at 4 trial locations

Overseen By Shira Blady, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: No cell phone

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of four methods best helps smokers quit for at least six months. Researchers will divide participants into groups to receive different types of support, including financial incentives, a mobile health application, and cost-free access to certain medications. The trial seeks current smokers who have undergone lung cancer screening and are considered underserved, such as those with lower income or limited access to healthcare. Participants must have a cell phone capable of receiving texts or accessing the internet. As an unphased trial, this study offers a unique opportunity to explore innovative methods for quitting smoking and improving health outcomes.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that offering money can safely and effectively help people quit smoking. One study found that financial rewards increased the chances of quitting by about 1.5 times without major safety issues.

Regarding mobile health (mHealth) apps, research indicates they can assist in quitting smoking. Although some concerns exist about the safety of health apps in general, most studies suggest they are safe for users. These apps can track progress and provide support. It is advisable to read app reviews and choose ones from trusted sources.

Both financial incentives and mHealth apps aim to make quitting smoking easier and safer. They have been widely studied, and while no method is completely risk-free, these tools are generally well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they incorporate innovative methods to help people quit smoking, especially for those undergoing lung cancer screening. Unlike standard approaches that often rely solely on advice and resources, these treatments use financial incentives and mobile health applications to motivate smokers. One unique feature is the use of episodic future thinking (EFT) through the FutureMe intervention, which encourages individuals to envision their future selves, helping to reduce the tendency to prioritize immediate rewards over long-term health benefits. Additionally, the removal of financial barriers by providing free access to nicotine replacement therapies and reimbursement for smoking cessation medications makes these treatments more accessible and potentially more effective.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that offering money can significantly increase the number of people who quit smoking. For instance, one study found that financial rewards helped more people stop smoking at a low cost per quitter. In this trial, some participants will receive financial incentives as part of their treatment arm. Mobile health apps also show promise; studies have shown they can triple the likelihood of quitting smoking within three to six months compared to older methods. These apps are easy to use and have proven effective in helping people stop smoking. Participants in this trial may receive a mobile health application as part of their treatment arm. Both financial incentives and mobile apps offer solid support for quitting smoking, making them effective options for helping smokers stay smoke-free. ^{1 2 3 6 7}

Who Is on the Research Team?

Scott D Halpern, MD PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for underserved adult smokers referred for lung cancer screening. Participants must be 18+, have a cell phone with text or internet, and meet at least one of these: Black, Hispanic, rural resident, or low income. They should smoke at least 1 cigarette per day and not use e-cigarettes.

Inclusion Criteria

My doctor has ordered a low-dose CT scan for me.

Access to a cell phone with text messaging or the internet

You are Black, Hispanic, live in a rural area, or have a low income or education level.

Exclusion Criteria

No cell phone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment and Pre-Quit Preparation

Participants enroll with opt-out consent and prepare for their quit date using the NIH-funded Way to Health online research portal

2 weeks

Online engagement

Treatment

Participants receive one of four interventions to promote smoking cessation, including enhanced usual care, financial incentives, and mobile health applications

6 months

Regular online check-ins and biochemical confirmation at 2 weeks, 3 months, and 6 months

Follow-up

Participants are monitored for relapse rates and health-related quality of life at 12 months

6 months

Online assessments at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Financial Incentives
• Mobile Health Application
• Removal of Financial Barriers

Trial Overview The study compares four ways to help people quit smoking: removing cost barriers to quitting aids, offering money rewards for staying smoke-free, using a mobile app designed to support quitting efforts. The goal is to see which method helps maintain no smoking for six months.

How Is the Trial Designed?

Group I: Enhanced Usual Care plus Financial Incentives plus Mobile Health Application Active Control 3 Interventions

Participants receive all aspects of Arm 3 plus an intervention to promote episodic future thinking (EFT), called FutureMe. EFT has been shown to reliably reduce discounting of the future. Patients will practice using EFT cues to envision the "future is now" between the time of enrollment and the quit date, and will then receive cues from the quit date through the end of the intervention period, 6 months later, unless they ask to stop receiving cues sooner.

Group II: Enhanced Usual Care plus Financial Incentives Active Control 2 Interventions

Participants receive all aspects of enhanced usual care plus an incentive plan in which they will be informed of their eligibility to earn $100, $200, and $300 if they submit negative tests for nicotine metabolites at 2 weeks, 3 month and 6 months following their quit date, respectively.

Group III: Basic Usual Care Active Control 1 Intervention

Participants receive the usual care approach, Ask-Advise-Refer (AAR), which is a standard approach in which non-study clinicians ask smokers about their desire to quit smoking, advise them to quit, and provide informational resources such as hotlines, specialized clinics, or smoking cessation classes.

Group IV: Enhanced Usual Care Active Control 1 Intervention

Participants receive the basic usual care of Ask-Advise-Refer as well as free access to nicotine replacement therapy (NRT) and/or reimbursement of up to $300 for any smoking cessation medications (varenicline/Chantix or bupropion/Zyban) prescribed by non-study clinicians.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A study involving 181 participants found that most users rated the smoking cessation app QuitPal-m as very helpful, but daily usage declined over time, indicating a need for ongoing support to maintain engagement.

The effectiveness of the app was enhanced by supportive accountability from cessation counselors, particularly for smokers with low motivation to quit, highlighting the importance of addressing both personal barriers and technical issues to improve app usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Accountability and Mobile App Use in a Tobacco Control Intervention Targeting Low-Income Minority Mothers Who Smoke: Observational Study. Lepore, SJ., Collins, BN., Killam, HW., et al.[2023]

Mobile health applications are effective tools for helping individuals change their smoking habits, as they provide counseling and motivation for smoking cessation.

The review analyzed 12 studies that highlighted four different technological approaches, demonstrating the versatility and potential of mobile devices in supporting smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. Kefaliakos, A., Pliakos, I., Chardalias, K., et al.[2018]

This study evaluates a proactive enrollment strategy linking lung cancer screening (LCS) smokers to a digital cessation intervention (web-based and text messaging), aiming to improve biochemically confirmed abstinence rates at 12 months post-randomization among 1650 participants.

The research will compare the effectiveness of a digital intervention alone versus one combined with tobacco treatment specialist counseling, with the expectation that the combined approach may yield higher quit rates, although it may be less cost-effective for implementation in LCS programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial. Graham, AL., Burke, MV., Jacobs, MA., et al.[2019]

This systematic review aims to evaluate the effectiveness of mobile health (mHealth) interventions for smoking cessation by analyzing randomized controlled trials, which will help identify how to improve the design of these interventions.

The review will use a random-effects meta-analysis to summarize the effectiveness of mHealth interventions, focusing on self-reported smoking abstinence and service uptake, providing a comprehensive understanding of how mobile phone-based strategies can support smokers in quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying effective components for mobile health behaviour change interventions for smoking cessation and service uptake: protocol of a systematic review and planned meta-analysis. Kingkaew, P., Glidewell, L., Walwyn, R., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11220567/

Financial Incentives for Smoking Cessation Among ... This randomized clinical trial compares the long-term effects of adjunctive, low-cost financial incentives plus usual care for smoking cessation.

2. pcori.org pcori.org/research-results/2018/comparing-effectiveness-four-ways-promote-quitting-smoking-adult-smokers-referred-lung-cancer-screenings

Comparing the Effectiveness of Four Ways To Promote ... Results from this study can help lung cancer screening programs choose the best ways to help people quit smoking.

3. jto.org jto.org/article/S1556-0864(25)00175-3/fulltext

Reducing Lung Cancer Mortality by Providing Smoking ... SCS delivered in the LCS setting can considerably reduce lung cancer mortality, with the potential to reduce global, racial, economic, and geographic ...

4. ilcn.org ilcn.org/global-insights-into-smoking-cessation-in-lung-cancer-screening/

Global Insights into Smoking Cessation in Lung Cancer ... - ILCN Smoking cessation interventions are a critical component of lung cancer screening (LCS) programs, as they have been shown to reduce smoking-related risks and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1098301518332637

Paying Low-Income Smokers to Quit? The Cost ... The ICER of the financial incentives intervention was $2316 (95% confidence interval $1582–$4270) per additional person who quit. The study ICER compares ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0306460323000357

Effects of large financial incentives on motivation to quit ... A Cochrane meta-analysis of randomized trials concluded that financial incentives increase smoking cessation rates by a factor of 1.49, and that this effect is ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02737566

Small Financial Incentives to Promote Smoking Cessation Participants will receive a payment for completion of the in-person assessments, which will take approximately 40 minutes to complete. Saliva cotinine will also ...