Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

Lung Diseases Clinical Trial

— PROACT  

Official title:

Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612804
• Other study ID #: IIR 16-071
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: February 9, 2023

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 828
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Neoplasms
• Smoking Reduction
• Tobacco Smoking
• Tobacco Use
• Tomography

Intervention

Behavioral:
• Unsigned note to provider about cessation medication prescription
For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.
• Proactive Telephone Counseling from VA Quitline
Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.

Locations

Country	Name	City	State
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Fred Hutchinson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported smoking abstinence	The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records	12 months after lung cancer screening visit
Secondary	Providers' acceptance of proactive cessation care	Provider surveys will assess acceptance of and satisfaction with the proactive care approach among primary care clinicians referring Veterans for lung cancer screening	0-12 weeks after provider offers patient lung cancer screening
Secondary	Cost of proactive cessation care	Costs of implementing the proactive care approach will be monitored and analyzed, including intervention staff effort, provider time, costs of telephone counseling, and pharmacotherapy costs	Through study completion
Secondary	Patients' experience with telephone counseling	Patient surveys will assess satisfaction with VA Quitline telephone counseling	3 months after lung cancer screening visit
Secondary	Patients' motivational assessment	Surveys will assess patient motivation to quit smoking	3 months after lung cancer screening visit
Secondary	Patients' perception of susceptibility to harm	Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective	3 months after lung cancer screening visit
Secondary	Patients' self-efficacy assessment	Surveys will assess patients' self-efficacy for quitting smoking	3 months after lung cancer screening visit
Secondary	Patients' motivational assessment	Surveys will assess patient motivation to quit smoking	12 months after lung cancer screening visit
Secondary	Patients' perception of susceptibility to harm	Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective	12 months after lung cancer screening visit
Secondary	Patients' self-efficacy assessment	Surveys will assess patients' self-efficacy for quitting smoking	12 months after lung cancer screening visit