MedPath

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

Not Applicable
Completed
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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey6 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
NameTimeMethod
Short-term Smoking Abstinence - Patient Survey3 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-Smokers6 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

Scroll for more (39 remaining)
Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.