An interventional study of Personnel Training and Coaching Calls in Smoking Cessation, sponsored by Wake Forest University Health Sciences. Completed at 49 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-25.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research
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.
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.
Exclusion Criteria:
Training of Lung Cancer Screening Personnel on implementation of the United States Public Health Service (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)
Other: Personnel Training and Coaching Calls
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)
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.
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)
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)
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)
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
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.
| Milestone | Intervention | Usual Care |
|---|---|---|
| Started | 523 | 571 |
| 14 day follow-up | 483 | 547 |
| 3 month follow-up | 445 | 538 |
| Completed | 442 | 514 |
| Not completed | 81 | 57 |
| Withdrew: Lost to follow-up | 62 | 43 |
| Withdrew: Refused to answer | 5 | 2 |
| Withdrew: Death | 2 | 4 |
| Withdrew: Not interested in participating | 8 | 6 |
| Withdrew: Too busy to participate | 4 | 2 |
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.
| percentage of participants | Intervention | Usual Care |
|---|---|---|
| Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey | 13.0 (9.7 to 17.4) | 13.5 (10.3 to 17.6) |
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.
| Participants | Intervention | Usual Care |
|---|---|---|
| High: greater than or equal to 15 mg/mL | 13 | 10 |
| Low: Less than 15 mg/mL | 10 | 20 |
| Unknown, not tested | 28 | 31 |
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.
| percentage of participants | Intervention | Usual Care |
|---|---|---|
| Short-term Smoking Abstinence - Patient Survey | 6.5 (4.4 to 9.5) | 5.5 (3.8 to 8.0) |
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.
| total services reported | Intervention | Usual Care |
|---|---|---|
| Total Number of Services Participant Reported Received at 14 Days | 7.51 ± 6.33 | 7.86 ± 6.07 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 2/523 (0.4%) | — | — |
| Usual Care | 4/571 (0.7%) | — | — |
1094 excludes the 6 that were deemed ineligible from the total of 1100 recruited
| Age, Customized(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| Age in years — 55-64 | 286 | 333 | 619 |
| Age in years — 65-74 | 213 | 220 | 433 |
| Age in years — 75 or older | 24 | 18 | 42 |
| Sex/Gender, Customized(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| Gender, participant reported — Male | 249 | 281 | 530 |
| Gender, participant reported — Female | 269 | 283 | 552 |
| Gender, participant reported — Non-Binary | 2 | 3 | 5 |
| Gender, participant reported — Not Reported | 3 | 4 | 7 |
| Race/Ethnicity, Customized(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| Race/Ethnicity — White, non-Hispanic | 423 | 452 | 875 |
| Race/Ethnicity — Black, non-Hispanic | 68 | 74 | 142 |
| Race/Ethnicity — Hispanic, all races | 5 | 23 | 28 |
| Race/Ethnicity — American Indian, non-Hispanic | 11 | 13 | 24 |
| Race/Ethnicity — Not Reported | 16 | 9 | 25 |
| Education(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| No high school degree, high school degree, or completion of General Education Development (GED) test | 248 | 307 | 555 |
| Some post high school education or college degree or graduate degree | 272 | 260 | 532 |
| Not reported | 3 | 4 | 7 |
| Annual Household Income(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| Less than $15000 | 94 | 137 | 231 |
| $15000 - $34999 | 113 | 133 | 246 |
| $35000 - $64999 | 116 | 116 | 232 |
| $65000 or higher | 117 | 109 | 226 |
| Not Reported | 83 | 76 | 159 |
| Marital Status(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| Married | 265 | 284 | 549 |
| Not Currently Married | 254 | 283 | 537 |
| Not Reported | 4 | 4 | 8 |
| Employment(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| Working full- or part-time | 173 | 187 | 360 |
| Retired | 226 | 226 | 452 |
| Disabled | 98 | 124 | 222 |
| Homemaker, Caregiver, Student, or Unemployed | 24 | 31 | 55 |
| Not Reported | 2 | 3 | 5 |
| Personal Cancer History(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| Count of participants | 41 | 40 | 81 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Wake Forest (WF) NCORP Research Base (RB) is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI National Clinical Trials Network (NCTN)/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials (https://nctn-data-archive.nci.nih.gov/). This will become the primary means for sharing raw data and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide.
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Wake Forest University Health Sciences