Smoking Cessation in Patients With Cancer

Continued cigarette smoking after a cancer diagnosis is clinically important, and smoking cessation is an important component of cancer care. This study is a randomized, two-arm, parallel-group superiority trial evaluating the incremental effect of structured CBT-based smoking-cessation counseling when added to standardized brief smoking-cessation counseling. Eligible participants smoked combustible cigarettes at cancer diagnosis and are still smoking combustible cigarettes at screening and enrollment.

After eligibility confirmation, written informed consent, and baseline assessment, every enrolled participant will receive one standardized individual face-to-face brief smoking-cessation counseling session lasting approximately 3-5 minutes using a condensed 5A framework (Ask, Advise, Assess, Assist, and Arrange). Only after this common counseling is completed will the SNOSE allocation envelope be opened and the participant randomized 1:1. The control arm receives no additional study CBT. The intervention arm receives one additional individual structured CBT-based smoking-cessation session lasting approximately 20-30 minutes.

A participant randomized to the intervention arm may decline the CBT session without being reassigned or rerandomized. The refusal and reason, if provided, will be recorded; outcome follow-up will continue if the participant agrees, and the participant will remain analyzed in the originally randomized arm under ITT.

Participants will be followed for 3 months after randomization. The primary outcome is self-reported 7-day point-prevalence cigarette smoking abstinence at Month 3. CSS-21 and a separate nicotine-withdrawal assessment are administered only at Month 3. The study will enroll the prespecified target of 446 participants (223 per arm).

Inclusion criteria

• Aged 18 years or older.
• Diagnosed with cancer.
• Was smoking combustible cigarettes at the time of cancer diagnosis.
• Still smoking combustible cigarettes at screening/enrollment.
• Able to communicate sufficiently and provide reliable study information.
• Provides written informed consent.

Exclusion criteria

• Clinically too severe for reliable participation.
• Cognitive/communication limitations precluding consent or reliable participation.
• Currently participating in a competing structured smoking-cessation program.
• Concurrent use of tobacco/nicotine products other than combustible cigarettes (e-cigarette, heated tobacco product, waterpipe/shisha, cigar, pipe, smokeless tobacco, etc.). Outside therapeutic NRT/cessation medications are not an exclusion.