Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites
- Conditions
- Smoking Cessation
- Interventions
- Other: Personnel Training and Coaching Calls
- 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
- Arm && Interventions
Group Intervention Description Intervention Personnel Training and Coaching Calls 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)
- 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)
Augusta University Medical Center
🇺🇸Augusta, Georgia, United States
Mercy Hospital Joplin
🇺🇸Joplin, Missouri, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
🇺🇸Savannah, Georgia, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Freeman Health System
🇺🇸Joplin, Missouri, United States
Delbert Day Cancer Institute at PCRMC
🇺🇸Rolla, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
🇺🇸Rolla, Missouri, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Prisma Health Cancer Institute - Easley
🇺🇸Easley, South Carolina, United States
Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
McFarland Clinic PC - Ames
🇺🇸Ames, Iowa, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
LSU Health Sciences Center at Shreveport
🇺🇸Shreveport, Louisiana, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
William Beaumont Hospital-Royal Oak
🇺🇸Royal Oak, Michigan, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Saint Louis Cancer and Breast Institute-Ballwin
🇺🇸Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar
🇺🇸Bolivar, Missouri, United States
Cox Cancer Center Branson
🇺🇸Branson, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
Mercy Hospital Washington
🇺🇸Washington, Missouri, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Montefiore Medical Center - Moses Campus
🇺🇸Bronx, New York, United States
Saint Mary's Regional Medical Center
🇺🇸Reno, Nevada, United States
Sanford Roger Maris Cancer Center
🇺🇸Fargo, North Dakota, United States
Novant Health Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Sanford South University Medical Center
🇺🇸Fargo, North Dakota, United States
Mercy Hospital Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Prisma Health Cancer Institute - Laurens
🇺🇸Clinton, South Carolina, United States
Prisma Health Cancer Institute - Spartanburg
🇺🇸Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Butternut
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
🇺🇸Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Seneca
🇺🇸Seneca, South Carolina, United States
Prisma Health Cancer Institute - Greer
🇺🇸Greer, South Carolina, United States
Baptist Memorial Hospital and Cancer Center-Memphis
🇺🇸Memphis, Tennessee, United States
VCU Massey Cancer Center at Stony Point
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States