Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites
- Conditions
- Smoking Cessation
- Registration Number
- NCT03291587
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1094
- 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".
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (49)
Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States
Augusta University Medical Center
🇺🇸Augusta, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
🇺🇸Savannah, Georgia, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
McFarland Clinic PC - Ames
🇺🇸Ames, Iowa, United States
Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
LSU Health Sciences Center at Shreveport
🇺🇸Shreveport, Louisiana, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
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