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OpenTrials
Completed

NCT Number: NCT04798664

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Southern California, Oakland, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • No cell phone

Treatment and study plan

Removal of Financial Barriers

Behavioral

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

Other names: NRT, Pharmacotherapy

Financial Incentives

Behavioral

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

Other names: Incentives

Mobile Health Application

Behavioral

Episodic future thinking tool to overcome temporal discounting of future

Other names: FutureMe

Primary outcomes

  1. Biochemically Confirmed Smoking Abstinence Sustained for 6 Months

    Time frame: 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.

Secondary outcomes

  1. Quit Status (Biochemically Confirmed)

    Time frame: 2 weeks, 3 months, 12 months

    Rates of sustained biochemically confirmed smoking cessation

  2. Health-related Quality of Life

    Time frame: Baseline

    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.

  3. Perceived Barriers to Cessation

    Time frame: Baseline

    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.

  4. Self-efficacy Related to Cessation Efforts

    Time frame: Baseline

    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.

  5. Motivation to Quit

    Time frame: Baseline

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

  6. Temporal ("Delay") Discounting

    Time frame: Baseline

    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.

  7. Health-related Quality of Life

    Time frame: 6 months

    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.

  8. Perceived Barriers to Cessation

    Time frame: 6 months

    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.

  9. Self-efficacy Related to Cessation Efforts

    Time frame: 6 months

    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.

  10. Motivation to Quit

    Time frame: 6 months

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

  11. Temporal ("Delay") Discounting

    Time frame: 6 months

    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.

  12. Health-related Quality of Life

    Time frame: 12 months

    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.

  13. Perceived Barriers to Cessation

    Time frame: 12 months

    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.

  14. Self-efficacy Related to Cessation Efforts

    Time frame: 12 months

    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.

  15. Motivation to Quit

    Time frame: 12 months

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

  16. Temporal ("Delay") Discounting

    Time frame: 12 months

    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.

  17. Self-report Cigarette Abstinence

    Time frame: 2 weeks, 3 months, 6 months, 12 months

    Rates of sustained self-reported cigarette abstinence

  18. Self-report Other Tobacco Abstinence

    Time frame: 2 weeks, 3 months, 6 months, 12 months

    Rates of sustained self-reported other tobacco abstinence

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Mar 15, 2021
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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