Trial Outcomes & Findings for Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening (NCT NCT04798664)

Virtual outreach: 05/17/21-01/17/24. Potentially eligible patients received text messages and/or emails inviting them to complete an eligibility survey. Clinic outreach: 05/17/21-01/17/24. Patients who had not yet completed eligibility screening were handed an iPad with the enrollment URL when coming in for their LCDT appointment. Enrollment concluded on 01/31/24.

Eligible patients had the opportunity to review frequently asked questions and opt out of enrollment. Patients who neither opted out nor clicked 'Complete' to be randomized received an email and/or text message after 14 days, instructing them to notify the team if they did not wish to participate; otherwise, the patient was randomized three days later. This process was called 'last chance to opt out' (LCOO; 03/17/22-01/08/24).

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

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.

Rates of sustained biochemically confirmed smoking cessation

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.

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.

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.

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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

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.

Rates of sustained self-reported cigarette abstinence

Rates of sustained self-reported other tobacco abstinence