Clinical trial NCT03612804: Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment
Official title: Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Reduction
Tobacco Use
Tobacco Smoking
Tomography
Lung Diseases
Lung Neoplasms
Keywords: smoking cessation
lung cancer screening
telephone counseling
quitline
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Fred Hutchinson Cancer Center
First posted: 2018-08-02
Enrollment: 944
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.

Detailed description: This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.

Eligibility criteria: Inclusion Criteria:

* Providers who schedule patients for a lung cancer screening at either of the two VA sites.
* Patients who participate in lung cancer screening and are current smokers at the time of scheduling their screening exam.

Exclusion Criteria:

* Providers who currently systematically prescribe cessation support medication to all current smokers will be excluded.
* Patients with urgent findings requiring biopsy/immediate attention on the screening CT will be excluded.
* Patients with a prior diagnosis of lung cancer or who are receiving active therapy for any cancer, except skin cancer, will be excluded.
* Patients previously diagnosed with cognitive impairment, dementia, or severe behavioral disorders, or have an indication in chart review of difficulty communicating or participating in telephone counseling sessions will be excluded.

Primary outcomes:
measure: Self-reported Smoking Abstinence
timeFrame: 12 months after lung cancer screening visit
Secondary outcomes:
measure: Cost of Smoking Cessation Care
timeFrame: Time period from lung cancer screening through 12 months after lung cancer screening
measure: Patients' Experience With Telephone Counseling
timeFrame: 3 months after lung cancer screening visit
measure: Patients' Motivational Assessment
timeFrame: 3 months after lung cancer screening visit
measure: Patients' Perception of Susceptibility to Harm
timeFrame: 3 months after lung cancer screening visit
measure: Patients' Self-efficacy Assessment
timeFrame: 3 months after lung cancer screening visit
measure: Patients' Motivational Assessment
timeFrame: 12 months after lung cancer screening visit
measure: Patients' Self-efficacy Assessment
timeFrame: 12 months after lung cancer screening visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Steven B Zeliadt, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: