Smoking Cessation Interventions for Lung Cancer Screening Patients

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

3228 Participants Needed

Trial Summary

What is the purpose of this trial?

To compare the effectiveness of four interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among underserved smokers referred for lung cancer screening at four large U.S. health systems.

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.

What data supports the effectiveness of the treatment Financial Incentives, Mobile Health Application, mHealth Apps, Mobile Health Technology, Diabetes Management Apps, Removal of Financial Barriers for smoking cessation?

Research shows that mobile health apps can help people quit smoking, though improvements are often modest. Digital interventions, like web-based and text message programs, have been effective and cost-efficient, especially when they proactively connect smokers to treatment. ^{1 2 3 4 5}

Is it safe to use mobile health apps for smoking cessation?

Research on mobile health apps for smoking cessation suggests they are generally safe for use in humans, as they focus on digital support and engagement rather than introducing new medications or physical interventions. ^{1 2 6 7 8}

How is the smoking cessation treatment for lung cancer screening patients different from other treatments?

This treatment is unique because it integrates digital tools like web-based and text message interventions within lung cancer screening programs, making it scalable and cost-efficient. It proactively connects smokers to cessation support through healthcare system changes, such as automatic referrals via electronic health records, rather than relying on passive referrals. ^{1 2 6 9 10}

Research Team

Scott D Halpern, MD PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Effects of a Mobile App Called Quittr, Which Utilizes Premium Currency and Games Features, on Improving Engagement With Smoking Cessation Intervention: Pilot Randomized Controlled Trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial. [2019]

3. England 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Adaptive interventions to optimise the mobile phone-based smoking cessation support: study protocol for a sequential, multiple assignment, randomised trial (SMART). [2022]

5. Canada 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Associations Between Engagement and Outcomes in the SmokefreeTXT Program: A Growth Mixture Modeling Analysis. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Mobile Health Tobacco Cessation Interventions to Promote Health Equity: Current Perspectives. [2023]

8. England pubmed.ncbi.nlm.nih.gov

What Do People Want in a Smoking Cessation App? An Analysis of User Reviews and App Quality. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. [2018]

10. Canada pubmed.ncbi.nlm.nih.gov

Design Considerations for mHealth Programs Targeting Smokers Not Yet Ready to Quit: Results of a Sequential Mixed-Methods Study. [2019]