Smoking Cessation
Conditions
Keywords
Patients, Underserved, Early Detection of Cancer, Lung Cancer, Nicotine Replacement Products, Incentives, Behavioral Economics, Smoking Cessation, Nicotine Dependence
Brief 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.
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.
Interventions
BEHAVIORALRemoval of Financial Barriers
Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications
BEHAVIORALFinancial Incentives
Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.
BEHAVIORALMobile Health Application
Episodic future thinking tool to overcome temporal discounting of future
Sponsors
Abramson Cancer Center at Penn Medicine
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically Confirmed Smoking Abstinence Sustained for 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Quit Status (Biochemically Confirmed) | 2 weeks, 3 months, 12 months | Rates of sustained biochemically confirmed smoking cessation |
| Health-related Quality of Life | 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. |
| Perceived Barriers to Cessation | 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. |
| Self-efficacy Related to Cessation Efforts | 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. |
| Motivation to Quit | Baseline | The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit. |
| Temporal ("Delay") Discounting | 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. |
| Self-report Cigarette Abstinence | 2 weeks, 3 months, 6 months, 12 months | Rates of sustained self-reported cigarette abstinence |
| Self-report Other Tobacco Abstinence | 2 weeks, 3 months, 6 months, 12 months | Rates of sustained self-reported other tobacco abstinence |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORScott D Halpern, MD PhD
University of Pennsylvania
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 6.38 |
| Education Associate or Bachelor Degree | 223 participants |
| Education Did not graduate from high school | 393 participants |
| Education Graduate degree | 175 participants |
| Education High school degree or equivalent | 348 participants |
| Education Some college but no degree | 571 participants |
| Elixhauser Comorbidity Index (van Walraven) | 3.60 units on a scale STANDARD_DEVIATION 7.58 |
| Have Smartphone with Internet No | 147 Participants |
| Have Smartphone with Internet Yes | 503 Participants |
| Income (%FPL) 0-199% Federal Poverty Line | 401 participants |
| Income (%FPL) 200-400+% Federal Poverty Line | 1695 participants |
| Income (%FPL) Missing | 4 participants |
| Insurance Commercial | 437 Participants |
| Insurance Medicaid | 95 Participants |
| Insurance Medicare | 198 Participants |
| Insurance Missing | 2 Participants |
| Insurance Self-pay | 1 Participants |
| LDCT screening results Concerning | 248 Participants |
| LDCT screening results Reassuring | 634 Participants |
| Number of prior LDCT screening tests (prior to enrollment) | 1.43 number of scans STANDARD_DEVIATION 1.5 |
| Presence of mental health diagnoses Missing | 6 Participants |
| Presence of mental health diagnoses No | 312 Participants |
| Presence of mental health diagnoses Yes | 289 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 10 participants |
| Race/Ethnicity, Customized Asian or Asian American | 23 participants |
| Race/Ethnicity, Customized Black or African American | 224 participants |
| Race/Ethnicity, Customized Decline | 7 participants |
| Race/Ethnicity, Customized Multiple | 68 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 participants |
| Race/Ethnicity, Customized No | 2941 participants |
| Race/Ethnicity, Customized Other | 118 participants |
| Race/Ethnicity, Customized White or Caucasian | 583 participants |
| Race/Ethnicity, Customized Yes-Cuban | 0 participants |
| Race/Ethnicity, Customized Yes-Mexican | 38 participants |
| Race/Ethnicity, Customized Yes-Other | 15 participants |
| Race/Ethnicity, Customized Yes-Puerto Rican | 18 participants |
| Rurality (self-report) Don't know: RUCA1 | 65 participants |
| Rurality (self-report) Don't know: Rural ZIP (not RUCA1) | 12 participants |
| Rurality (self-report) No, not rural | 294 participants |
| Rurality (self-report) Yes, rural | 253 participants |
| Sex: Female, Male Female | 513 Participants |
| Sex: Female, Male Male | 1280 Participants |
| Sex/Gender, Customized Man | 184 participants |
| Sex/Gender, Customized Missing | 596 participants |
| Sex/Gender, Customized Self-describe | 1 participants |
| Sex/Gender, Customized Woman | 440 participants |
| Time of accrual Enrolled after 9/18/2022 | 335 Participants |
| Time of accrual Enrolled on or before 9/18/2022 (pandemic era) | 367 Participants |
| Tobacco/ Nicotine dependence 11-20 | 264 participants |
| Tobacco/ Nicotine dependence 1-4 | 109 participants |
| Tobacco/ Nicotine dependence 21-30 | 103 participants |
| Tobacco/ Nicotine dependence 31 or more | 24 participants |
| Tobacco/ Nicotine dependence 5-7 | 77 participants |
| Tobacco/ Nicotine dependence 8-10 | 96 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 605 | 6 / 889 | 1 / 889 | 1 / 845 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed