Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementation Of Smoking Cessation Services Within NCI NCORP Community Sites With Organized Lung Cancer Screening Programs

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Personnel Training and Coaching Calls


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months (after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | <= 14 days after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, cancer screening, tobacco use