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
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Among 920 studies in Smoking Cessation with a site in United States — 98 open to participants now, 126 under way, 7 of them phase 3. Smoking Cessation · United States.
Among the 920 studies in Smoking Cessation with a site in United States, this one is the 93rd largest by enrollment of the 872 interventional ones that give a count, is one of 51 that started in 2018, is one of 512 with no phase, and was the 551st registered.
1,582 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
Browse Smoking Cessation studies →98 of the 920 studies in Smoking Cessation with a site in United States are open now. Recruiting first, the newest first:
Seattle Institute for Biomedical and Clinical Research · Sites in United States
Ages 18+
VA Office of Research and Development · Sites in United States
Ages 18+
University of Minnesota · Sites in United States
Ages 21+ · Healthy volunteers
Axsome Therapeutics, Inc. · Sites in United States
Ages 18–65
Rutgers, The State University of New Jersey · Sites in United States
Ages 18–60
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 137 Smoking Cessation studies recruiting now, 93 (68%) set no upper age limit and 37 (27%) stop at 75 or younger; 6 take children under 18; 41 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
920 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 68 · Phase 2 138 · Phase 3 91 · Phase 4 99
First in 1996; this study’s year is marked. 51 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,094 is above the median of 164 across 1,424 interventional studies indexed under Smoking Cessation.
Median enrollment 149 across the 872 interventional studies, 200 across the 45 observational. Of the 756 that completed or were terminated, 376 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
88 of 920 have an industry lead sponsor. The 10 most frequent:
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 200 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Wake Forest University Health Sciences has 5 studies filed under Smoking Cessation — fewer than ten, so there is no comparison to draw.
54 of the studies in Smoking Cessation with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT05732272Phase 3University of Kansas Medical CenterImproving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment | 2027-01-31 |
| NCT06945120Dana-Farber Cancer InstituteACT Lung Health Intervention: Phase Two | 2026-11-30 |
| NCT00591175Memorial Sloan Kettering Cancer CenterA Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers | 2026-12 |
| NCT06837220University of ChicagoImplementation of Tobacco Cessation Programming at Community Behavioral Health Sites | 2026-12 |
Add all 54 to your calendar (.ics) → With an account.
Among the 920 studies in Smoking Cessation with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
PDFs hosted by the registry, ClinicalTrials.gov.
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.
Time frame: see NIH policy
Access criteria: request using uniform resource locator (URL) below
Data sharing details ↗ · nctn-data-archive.nci.nih.gov
Ran from Jun 2018 to primary completion in Feb 2021, 32 months.
Results were first posted in Jul 2022, 1 year 5 months after primary completion.
Of 547 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's 32 months is above that.
Counting every sponsor, half of 564 studies reached it within 24 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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