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.
Brief Title
Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Smoking Cessation
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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".
* 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".
Gender
All
Gender Based
false
Keywords
lung cancer
cancer screening
tobacco use
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03291587
Org Class
Other
Org Full Name
Wake Forest University Health Sciences
Org Study Id
IRB00040071
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Implementation Of Smoking Cessation Services Within NCI NCORP Community Sites With Organized Lung Cancer Screening Programs
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
Outcome Time Frame
6 months (after baseline)
Secondary Ids
Secondary Id
1R01CA207158-01
Secondary Id
REBAWF-20817CD
Secondary Id
NCI-2017-01669
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
6 months (after baseline)
Outcome Measure
Salivary Cotinine Test for Non-Smokers
Outcome Description
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.
Outcome Time Frame
3 months (after baseline)
Outcome Measure
Short-term Smoking Abstinence - Patient Survey
Outcome Description
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.
Outcome Time Frame
<= 14 days after baseline
Outcome Measure
Total Number of Services Participant Reported Received at 14 Days
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Dean Hosgood
Investigator Email
dean.hosgood@einsteinmed.org
Investigator Phone