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

Wake Forest University (WFU)

Status: Completed

Conditions: Smoking Cessation

Treatments: Other: Personnel Training and Coaching Calls

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03291587

REBAWF-20817CD (Other Identifier)

NCI-2017-01669 (Registry Identifier)

IRB00040071

1R01CA207158-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,094 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,094 participants in 2 patient groups

Intervention

Experimental group

Description:

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)

Treatment:

Other: Personnel Training and Coaching Calls

Usual Care

No Intervention group

Description:

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)