Smoking Cessation
Conditions
Keywords
lung cancer, cancer screening, tobacco use
Brief summary
Evaluate a multi-faceted training program to improve short-term smoking cessation rates (\<14 days post-visit) and short (3 months) and sustained abstinence (6 months) among 1,114 enrolled smokers who present for low-dose computed tomography (LDCT) lung cancer screening in 26 community-based practices.
Detailed description
We utilize an effectiveness-implementation hybrid design, employing a cluster, randomized control trial of community-based NCORP sites to study the effectiveness of a multi-faceted intervention to improve smoking cessation among lung cancer screening patients, as well as dissemination and implementation (D&I) science to optimize and accelerate translation of findings into clinical practice. We will: (1) Evaluate a multi-faceted training program to improve short-term smoking cessation rates (1-week post-visit) and sustained abstinence (6 months) among 1,114 enrolled smokers (557 in each trial arm) who present for LDCT lung cancer screening in community-based lung cancer screening practices; (2) Characterize the adoption and adaptation of the evidence-based tobacco cessation strategies in 26 community-based LDCT lung cancer screening programs; and (3) Develop and evaluate an implementation toolkit for integrating evidence-based tobacco cessation strategies in community-based LDCT lung cancer screening programs. Qualitative data will be collected from key informants at participating screening programs during and after intervention implementation. Quantitative survey data (baseline, \<14 days, 3 months, and 6 months) and saliva specimens (6 months only) will be collected from smoking patients receiving screening within these programs.
Interventions
OTHERPersonnel Training and Coaching Calls
Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Agrees to have NCORP research personnel serve as the study liaison and another person to serve as the cessation program champion. * Agrees to participate in all aspects of the intervention, randomization, and evaluation. * Agrees to participate in a confidential 1-on-1 semi-structured interview with the research team. * Agrees to have the interview taped, transcribed and qualitatively analyzed. * Age ≥18 years * Potential participants will be screened using the following question: Do you smoke cigarettes every day, some days, or not at all? (BRFSS). A current smoker is anyone responds every day or some days.
Exclusion criteria
* Current use (previous 30 days) of a tobacco dependence treatment including bupropion, varenicline, and nicotine replacement * Individuals who use e-cigarettes and who are not smoking cigarettes. Dual users (those who use both e-cigarettes and cigarettes) will still be included in the trial. * The presence of a physical or cognitive impairment that would prevent a person from engaging in survey research (such as blindness, deafness, or dementia). * Individual has already completed the intended LDCT lung cancer screening for this study. * Non-English speaking participants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey | 6 months (after baseline) | 7-day sustained smoking abstinence will be measured by the question Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days? in patient survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cotinine Test for Non-Smokers | 6 months (after baseline) | 7-day Sustained Smoking abstinence will be validated using a salivary cotinine test in non smokers. Abstinence will be determined by percentage of smokers whose tests come back negative for cotinine. Low levels of cotinine less than 15 milligrams per milliliter (mg/mL) would suggest true smoking cessation and levels higher than or equal to 15 mg/mL would suggest they are still smoking. |
| Short-term Smoking Abstinence - Patient Survey | 3 months (after baseline) | Short-tem smoking abstinence will be measured as part of the patient survey as the percentage of patients who report that they have not smoked. |
| Total Number of Services Participant Reported Received at 14 Days | <= 14 days after baseline | Fidelity to the intervention will be measured by a patient survey that asks patients if they received up to 18 cessation services during the screening visit. This is the total each participant reported receiving and can range from 0 to 18, with higher values representing more services. |
Countries
United States
Participant flow
Recruitment details
Twenty-six radiology facilities in twenty states were selected to participate. Clinics were matched based on lung screening volume and racial/ethnic diversity, and then assigned to the intervention or usual care group. Radiology facilities in the intervention arm participated in multi-faceted implementation strategies targeting the radiology facility and its clinical team. Each clinic was asked to recruit 50 participants.
Pre-assignment details
Goal was 1100 and there were 6 participants later found to be ineligible due to mis-specified eligibility criteria which is why we have 1094 total.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation. | 523 |
| Usual Care No training or performance coaching calls on personnel, just usual clinic practice.
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months) | 571 |
| Total | 1,094 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 4 |
| Overall Study | Lost to Follow-up | 62 | 43 |
| Overall Study | Not interested in participating | 8 | 6 |
| Overall Study | Refused to Answer | 5 | 2 |
| Overall Study | Too busy to participate | 4 | 2 |
Baseline characteristics
| Characteristic | Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Customized Age in years 55-64 | 286 Participants | 333 Participants | 619 Participants |
| Age, Customized Age in years 65-74 | 213 Participants | 220 Participants | 433 Participants |
| Age, Customized Age in years 75 or older | 24 Participants | 18 Participants | 42 Participants |
| Annual Household Income $15000 - $34999 | 113 Participants | 133 Participants | 246 Participants |
| Annual Household Income $35000 - $64999 | 116 Participants | 116 Participants | 232 Participants |
| Annual Household Income $65000 or higher | 117 Participants | 109 Participants | 226 Participants |
| Annual Household Income Less than $15000 | 94 Participants | 137 Participants | 231 Participants |
| Annual Household Income Not Reported | 83 Participants | 76 Participants | 159 Participants |
| Another smoker in the household | 166 Participants | 158 Participants | 324 Participants |
| Cigarettes per day | 17.3 number of cigarettes per day STANDARD_DEVIATION 10.4 | 17.1 number of cigarettes per day STANDARD_DEVIATION 8.9 | 17.2 number of cigarettes per day STANDARD_DEVIATION 9.6 |
| Education No high school degree, high school degree, or completion of General Education Development (GED) test | 248 Participants | 307 Participants | 555 Participants |
| Education Not reported | 3 Participants | 4 Participants | 7 Participants |
| Education Some post high school education or college degree or graduate degree | 272 Participants | 260 Participants | 532 Participants |
| Employment Disabled | 98 Participants | 124 Participants | 222 Participants |
| Employment Homemaker, Caregiver, Student, or Unemployed | 24 Participants | 31 Participants | 55 Participants |
| Employment Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Employment Retired | 226 Participants | 226 Participants | 452 Participants |
| Employment Working full- or part-time | 173 Participants | 187 Participants | 360 Participants |
| Family Cancer History | 136 Participants | 165 Participants | 301 Participants |
| Marital Status Married | 265 Participants | 284 Participants | 549 Participants |
| Marital Status Not Currently Married | 254 Participants | 283 Participants | 537 Participants |
| Marital Status Not Reported | 4 Participants | 4 Participants | 8 Participants |
| Pack Years | 45.7 pack of cigarettes per day per year STANDARD_DEVIATION 25.7 | 46.5 pack of cigarettes per day per year STANDARD_DEVIATION 24.3 | 46.1 pack of cigarettes per day per year STANDARD_DEVIATION 25 |
| Personal Cancer History | 41 Participants | 40 Participants | 81 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian, non-Hispanic | 11 Participants | 13 Participants | 24 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black, non-Hispanic | 68 Participants | 74 Participants | 142 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic, all races | 5 Participants | 23 Participants | 28 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Not Reported | 16 Participants | 9 Participants | 25 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White, non-Hispanic | 423 Participants | 452 Participants | 875 Participants |
| Sex/Gender, Customized Gender, participant reported Female | 269 Participants | 283 Participants | 552 Participants |
| Sex/Gender, Customized Gender, participant reported Male | 249 Participants | 281 Participants | 530 Participants |
| Sex/Gender, Customized Gender, participant reported Non-Binary | 2 Participants | 3 Participants | 5 Participants |
| Sex/Gender, Customized Gender, participant reported Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Smoke a cigarette within 30 minutes of waking | 372 Participants | 403 Participants | 775 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 523 | 4 / 571 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
7-day sustained smoking abstinence will be measured by the question Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days? in patient survey.
Time frame: 6 months (after baseline)
Population: Those with completed 6 month surveys.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Intervention | Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey | 13.0 percentage of participants |
| Usual Care | Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey | 13.5 percentage of participants |
Comparison: A generalized estimating equation marginal model was used in an intent-to-treat analysis to predict the 7-day tobacco use binary outcome. A binomial distribution with logit link was specified with group, time, and the interaction of group by time included as covariates while allowing intercept and time to vary by participants within site with an exchangeable working correlation matrix designation.p-value: 0.86596% CI: [0.652, 1.433]Mixed Models Analysis
Secondary
Salivary Cotinine Test for Non-Smokers
7-day Sustained Smoking abstinence will be validated using a salivary cotinine test in non smokers. Abstinence will be determined by percentage of smokers whose tests come back negative for cotinine. Low levels of cotinine less than 15 milligrams per milliliter (mg/mL) would suggest true smoking cessation and levels higher than or equal to 15 mg/mL would suggest they are still smoking.
Time frame: 6 months (after baseline)
Population: Cotinine was requested only for those that self-reported quitting for at least 7 days at the 6 month survey.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Salivary Cotinine Test for Non-Smokers | High: greater than or equal to 15 mg/mL | 13 Participants |
| Intervention | Salivary Cotinine Test for Non-Smokers | Low: Less than 15 mg/mL | 10 Participants |
| Intervention | Salivary Cotinine Test for Non-Smokers | Unknown, not tested | 28 Participants |
| Usual Care | Salivary Cotinine Test for Non-Smokers | High: greater than or equal to 15 mg/mL | 10 Participants |
| Usual Care | Salivary Cotinine Test for Non-Smokers | Low: Less than 15 mg/mL | 20 Participants |
| Usual Care | Salivary Cotinine Test for Non-Smokers | Unknown, not tested | 31 Participants |
Secondary
Short-term Smoking Abstinence - Patient Survey
Short-tem smoking abstinence will be measured as part of the patient survey as the percentage of patients who report that they have not smoked.
Time frame: 3 months (after baseline)
Population: Those that had 3 month surveys complete
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Intervention | Short-term Smoking Abstinence - Patient Survey | 6.5 percentage of participants |
| Usual Care | Short-term Smoking Abstinence - Patient Survey | 5.5 percentage of participants |
Secondary
Total Number of Services Participant Reported Received at 14 Days
Fidelity to the intervention will be measured by a patient survey that asks patients if they received up to 18 cessation services during the screening visit. This is the total each participant reported receiving and can range from 0 to 18, with higher values representing more services.
Time frame: <= 14 days after baseline
Population: Those that completed 14 day survey
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Total Number of Services Participant Reported Received at 14 Days | 7.51 total services reported | Standard Deviation 6.33 |
| Usual Care | Total Number of Services Participant Reported Received at 14 Days | 7.86 total services reported | Standard Deviation 6.07 |