Removal of Financial Barriers
BehavioralFree access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications
Other names: NRT, Pharmacotherapy
NCT Number: NCT04798664
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kaiser Permanente Southern California, Oakland, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications
Other names: NRT, Pharmacotherapy
Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.
Other names: Incentives
Episodic future thinking tool to overcome temporal discounting of future
Other names: FutureMe
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.
Time frame: 2 weeks, 3 months, 12 months
Rates of sustained biochemically confirmed smoking cessation
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.
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.
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.
Time frame: Baseline
The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.
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.
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.
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.
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.
Time frame: 6 months
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 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
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
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
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
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 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: 2 weeks, 3 months, 6 months, 12 months
Rates of sustained self-reported cigarette abstinence
Time frame: 2 weeks, 3 months, 6 months, 12 months
Rates of sustained self-reported other tobacco abstinence
Abramson Cancer Center at Penn Medicine
Other
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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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