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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3,228
Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications
Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.
Episodic future thinking tool to overcome temporal discounting of future
Kaiser Permanente Southern California
Oakland, California, United States
Henry Ford Health System
Detroit, Michigan, United States
Geisinger
Danville, Pennsylvania, United States
Lancaster General Health
Lancaster, Pennsylvania, United States
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.
Time frame: 6 months
Quit Status (Biochemically Confirmed)
Rates of sustained biochemically confirmed smoking cessation
Time frame: 2 weeks, 3 months, 12 months
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Time frame: Baseline
Motivation to Quit
The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
Motivation to Quit
The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
Motivation to Quit
The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.
Time frame: 12 months
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.
Time frame: 12 months
Self-report Cigarette Abstinence
Rates of sustained self-reported cigarette abstinence
Time frame: 2 weeks, 3 months, 6 months, 12 months
Self-report Other Tobacco Abstinence
Rates of sustained self-reported other tobacco abstinence
Time frame: 2 weeks, 3 months, 6 months, 12 months