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Smoking CessationNCT04798664

Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening

A study testing Removal of Financial Barriers, Financial Incentives and Mobile Health Application in people with Smoking Cessation, run by Abramson Cancer Center at Penn Medicine at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
Removal of Financial Barriers, Financial Incentives and Mobile Health Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,228 participants
Where
5 sitesUnited States
Study dates
17 May 2021to 29 Apr 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Current smoker (≥ 1 cigarettes per day, not including e-cigarettes)
  • Has a low-dose computed tomography (LDCT) scan ordered by their physician
  • Underserved, defined as one or more of the following: (a) Black, (b) Hispanic, (c) rural residence, or (d) low socioeconomic status (Defined as one or both of: high-school education or less, or household income <200% of the federal poverty line)
  • Able to receive study invitation and screening, by virtue of showing up to a radiology location affiliated with a participating health system for the LDCT, or having a valid email address or telephone number on file with the health system
  • Access to a cell phone with text messaging or the internet
  • Aged 18 years or older

Who cannot join

  • No cell phone

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites
  • Geisinger

    Danville, Pennsylvania, 17822

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Lancaster General Health

    Lancaster, Pennsylvania, 17601

  • Kaiser Permanente Southern California

    Oakland, California, 94612

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the detailed description

We will conduct a 4-arm randomized trial comparing 4 interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among smokers in underserved demographic groups. The 3,200 participants to be enrolled will be current smokers who are Black, Hispanic, and/or have low socioeconomic status (defined as household income <200% of the federal poverty line or a high school education or less) or rural residence who are referred for low-dose computed tomography (LDCT) screening at 4 large health systems. All adult patients with LDCT orders will be further screened for eligibility. Eligible patients will enroll with opt-out consent and complete the study using the NIH-funded Way to Health online research portal. The primary outcome will be biochemically confirmed, sustained abstinence from smoking tobacco for 6 months following participants' selected quit dates. Relapse rates will be tracked at 12 months.

Being tested
Removal of Financial Barriers, Financial Incentives, Mobile Health Application
Keywords
Patients, Underserved, Early Detection of Cancer, Lung Cancer, Nicotine Replacement Products, Incentives, Behavioral Economics, Smoking Cessation, Nicotine Dependence
Medical subject headings
Smoking Cessation, Lung Neoplasms, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Removal of Financial BarriersBehavioural

    Also called NRT, Pharmacotherapy

    Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications

  • Financial IncentivesBehavioural

    Also called Incentives

    Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.

  • Mobile Health ApplicationBehavioural

    Also called FutureMe

    Episodic future thinking tool to overcome temporal discounting of future

Study groups in NCT04798664
Study groupRoleWhat they receive
Basic Usual CareNo interventionParticipants 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.
Enhanced Usual CareActive comparatorParticipants 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.
Receives: Behavioral: Removal of Financial Barriers
Enhanced Usual Care plus Financial IncentivesActive comparatorParticipants 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.
Receives: Behavioral: Removal of Financial Barriers; Behavioral: Financial Incentives
Enhanced Usual Care plus Financial Incentives plus Mobile Health ApplicationActive comparatorParticipants 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.
Receives: Behavioral: Removal of Financial Barriers; Behavioral: Financial Incentives; Behavioral: Mobile Health Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically Confirmed Smoking Abstinence Sustained for 6 Months

    The primary outcome measure is sustained abstinence for 6 months, and will require self-report of smoking cessation followed by biochemical confirmation at 2 weeks, 3, and 6 months.

    Measured: 6 months

Secondary outcomes (18)
  1. Quit Status (Biochemically Confirmed)

    Rates of sustained biochemically confirmed smoking cessation

    Measured: 2 weeks, 3 months, 12 months

  2. Health-related Quality of Life

    The EuroQuol Group's quality of life (EQ-5D-5L) scale is a 25-item validated scale used to assess patients' perceived health-related quality of life across the domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Scale range: -1 to 1 index calculated from SAS package provided by author. Additionally calculating misery score which is sum of scores ranging from 5 to 25. For index, 1 is best possible health, while -1 are states worse than death. For the misery score, higher is worse health.

    Measured: Baseline

  3. Perceived Barriers to Cessation

    The Challenges to Stopping Smoking Scale (CSS-21) is a validated 21-item measure to assess patients' perceived barriers to smoking cessation. The CSS-21 has two sub-scales: intrinsic factors (physical, psychological or cognitive aspects of quitting), 9 item intrinsic factors scale from 9-36, and extrinsic factors (social or environmental aspects of quitting), 12 item extrinsic factors scale from 12-43. Total score was also prepared, range 21-79. A higher score means a greater challenge.

    Measured: Baseline

  4. Self-efficacy Related to Cessation Efforts

    We will use the 10-item situational measure of self-efficacy related to smoking behavior. This scale measures how sure participants are that they can avoid smoking in different situations. The scale ranges from 10-40, with a higher score demonstrating more self-efficacy.

    Measured: Baseline

  5. Motivation to Quit

    The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.

    Measured: Baseline

  6. Temporal ("Delay") Discounting

    Temporal discounting is a measure of impulsivity that reflects people's tendencies to discount the value of a reward as a function of how far in the future it would be received. We will use the 5-Trial Adjusting Delay Task to assess temporal discounting. The scale ranges from 0.000110 to 24, with a higher value meaning present is valued more over future gain. K values were calculated in R using the values noted in Koffarnus \& Bickel 2014.

    Measured: Baseline

  7. Health-related Quality of Life

    The EuroQuol Group's quality of life (EQ-5D-5L) scale is a 25-item validated scale used to assess patients' perceived health-related quality of life across the domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Scale range: -1 to 1 index calculated from SAS package provided by author. Additionally calculating misery score which is sum of scores ranging from 5 to 25. For index, 1 is best possible health, while -1 are states worse than death. For the misery score, higher is worse health.

    Measured: 6 months

  8. Perceived Barriers to Cessation

    The Challenges to Stopping Smoking Scale (CSS-21) is a validated 21-item measure to assess patients' perceived barriers to smoking cessation. The CSS-21 has two sub-scales: intrinsic factors (physical, psychological or cognitive aspects of quitting), 9 item intrinsic factors scale from 9-36, and extrinsic factors (social or environmental aspects of quitting), 12 item extrinsic factors scale from 12-43. Total score was also prepared, range 21-79. A higher score means a greater challenge.

    Measured: 6 months

  9. Self-efficacy Related to Cessation Efforts

    We will use the 10-item situational measure of self-efficacy related to smoking behavior. This scale measures how sure participants are that they can avoid smoking in different situations. The scale ranges from 10-40, with a higher score demonstrating more self-efficacy.

    Measured: 6 months

  10. Motivation to Quit

    The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.

    Measured: 6 months

  11. Temporal ("Delay") Discounting

    Temporal discounting is a measure of impulsivity that reflects people's tendencies to discount the value of a reward as a function of how far in the future it would be received. We will use the 5-Trial Adjusting Delay Task to assess temporal discounting. The scale ranges from 0.000110 to 24, with a higher value meaning present is valued more over future gain. K values were calculated in R using the values noted in Koffarnus \& Bickel 2014.

    Measured: 6 months

  12. Health-related Quality of Life

    The EuroQuol Group's quality of life (EQ-5D-5L) scale is a 25-item validated scale used to assess patients' perceived health-related quality of life across the domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Scale range: -1 to 1 index calculated from SAS package provided by author. Additionally calculating misery score which is sum of scores ranging from 5 to 25. For index, 1 is best possible health, while -1 are states worse than death. For the misery score, higher is worse health.

    Measured: 12 months

  13. Perceived Barriers to Cessation

    The Challenges to Stopping Smoking Scale (CSS-21) is a validated 21-item measure to assess patients' perceived barriers to smoking cessation. The CSS-21 has two sub-scales: intrinsic factors (physical, psychological or cognitive aspects of quitting), 9 item intrinsic factors scale from 9-36, and extrinsic factors (social or environmental aspects of quitting), 12 item extrinsic factors scale from 12-43. Total score was also prepared, range 21-79. A higher score means a greater challenge.

    Measured: 12 months

  14. Self-efficacy Related to Cessation Efforts

    We will use the 10-item situational measure of self-efficacy related to smoking behavior. This scale measures how sure participants are that they can avoid smoking in different situations. The scale ranges from 10-40, with a higher score demonstrating more self-efficacy.

    Measured: 12 months

  15. Motivation to Quit

    The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.

    Measured: 12 months

  16. Temporal ("Delay") Discounting

    Temporal discounting is a measure of impulsivity that reflects people's tendencies to discount the value of a reward as a function of how far in the future it would be received. We will use the 5-Trial Adjusting Delay Task to assess temporal discounting. The scale ranges from 0.000110 to 24, with a higher value meaning present is valued more over future gain. K values were calculated in R using the values noted in Koffarnus \& Bickel 2014.

    Measured: 12 months

  17. Self-report Cigarette Abstinence

    Rates of sustained self-reported cigarette abstinence

    Measured: 2 weeks, 3 months, 6 months, 12 months

  18. Self-report Other Tobacco Abstinence

    Rates of sustained self-reported other tobacco abstinence

    Measured: 2 weeks, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start17 May 2021
  3. Primary completion4 Nov 2024
  4. Study completion29 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective randomized controlled trial using opt-out consent with longitudinal follow-up of patients over 12 months. Based on the expected accrual at each of the four health systems, we expect that overall there will be 470 participants in basic usual care (Arm 1), and 910 participants in each of intervention arms 2-4.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04798664
Sponsor's protocol ID
UPCC 12519
Status last verified
Feb 2026
First submitted
11 Mar 2021
Last updated
25 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie published results will be made available to other researchers, after de-identification.

Publications

  • Hart JL, Vachani A, Neslund-Dudas CM, Gould MK, Facktor MA, Blady S, Bayes BA, Sheu D, Madden VL, Ferrante EB, Patel N, Tian J, Whitman C, Creekmur B, Kohn R, Simoff MJ, Volpp KG, Small D, Scott ME, Holm AL, Stephens Shields AJ, Halpern SD. Smoking Cessation Among Underserved Patients Referred for Lung Cancer Screening: A Randomized Clinical Trial. JAMA. 2026 Oct 5. doi: 10.1001/jama.2026.17192. Online ahead of print.

    PubMed 42832220
  • Kohn R, Vachani A, Small D, Stephens-Shields AJ, Sheu D, Madden VL, Bayes BA, Chowdhury M, Friday S, Kim J, Gould MK, Ismail MH, Creekmur B, Facktor MA, Collins C, Blessing KK, Neslund-Dudas CM, Simoff MJ, Alleman ER, Epstein LH, Horst MA, Scott ME, Volpp KG, Halpern SD, Hart JL; Stakeholder Advisory Committee. Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol. Ann Am Thorac Soc. 2022 Feb;19(2):303-314. doi: 10.1513/AnnalsATS.202104-499SD.

    PubMed 34384042

Questions about this trial

What is this clinical trial studying?

A study testing Removal of Financial Barriers, Financial Incentives and Mobile Health Application in people with Smoking Cessation, run by Abramson Cancer Center at Penn Medicine at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically Confirmed Smoking Abstinence Sustained for 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04798664, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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