Preventing Lung Cancer Through Tobacco Cessation at FDNY
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
At the Fire Department of the City of New York (FDNY) World Trade Center Health Program, 36% of participants in the low dose computed tomography (LDCT) lung cancer screening program are current smokers, despite referral to the free FDNY Tobacco Cessation Program (Standard Care). Investigators propose testing an Enhanced Care program which includes opt-out enrollment; tobacco cessation counseling will be individually tailored to spirometry/LDCT results and treatment with varenicline starting 4 weeks prior to their target quit date. This randomized trial will compare enrollment and cessation outcomes in Standard Care vs. Enhanced Care groups of challenging-to-treat, high-risk smokers.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:
• Enrolled in FDNY WTCHP
• Retired
• Age ≥ 50 years old
• Self-reported current smoker on most recent questionnaire OR self-reported current smoker in the past 5 years
• 20 pack-year smoker OR 20-year smoking duration
Locations
United States
New York
FDNY World Trade Center Health Program
RECRUITING
Brooklyn
Contact Information
Primary
Shadi Nahvi, MD, MS
shadi.nahvi@einsteinmed.edu
718 920 5379
Backup
David Goldfarb, PhD
david.goldfarb@fdny.nyc.gov
718 403 4413
Time Frame
Start Date:2024-05-31
Estimated Completion Date:2025-10
Participants
Target number of participants:320
Treatments
Experimental: Enhanced Treatment
Opt-out counseling enrollment. individually-tailored biofeedback linked to Chest CT and spirometry results.~Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28.~1 mg twice day for 12 weeks after target quit date.
Active_comparator: Standard Treatment
Opt-in counseling enrollment. Standard tobacco cessation counseling.~Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28.~1 mg twice day for 12 weeks after target quit date.