An interventional study of Standardized Brief Smoking-Cessation Counseling and Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling in Cancer and Tobacco Use, sponsored by Nguyen Duc Khoa, MD, PhD. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Nguyen Duc Khoa, MD, PhD · Not applicable, Interventional, and Treatment
This randomized controlled trial will evaluate whether adding one-session structured cognitive behavioral therapy (CBT)-based smoking-cessation counseling to standardized brief smoking-cessation counseling improves cigarette smoking abstinence among patients with cancer who smoked combustible cigarettes at diagnosis and are still smoking at screening and enrollment. After written informed consent and baseline assessment, all participants will receive the same standardized brief smoking-cessation counseling using a condensed 5A framework. Participants will then be randomly assigned 1:1 to no additional study CBT or to one additional structured CBT-based smoking-cessation session. Follow-up will continue for 3 months after randomization at Campus 3 of Vietnam National Cancer Hospital in Hanoi, Vietnam.
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).
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This study's planned enrollment of 446 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before randomization, all participants receive the same individual face-to-face standardized brief smoking-cessation counseling session lasting approximately 3-5 minutes using a condensed 5A framework. After randomization, participants allocated to the control arm receive no additional study CBT. Study outcome follow-up is identical in both arms.
Behavioral: Standardized Brief Smoking-Cessation Counseling
Before randomization, all participants receive the same standardized brief 5A smoking-cessation counseling. After randomization, participants allocated to the intervention arm are offered one additional individual structured CBT-based smoking-cessation counseling session lasting approximately 20-30 minutes. Declining CBT after randomization does not change randomized assignment; follow-up continues if the participant agrees.
Behavioral: Standardized Brief Smoking-Cessation Counseling · Behavioral: Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling
Common pre-randomization care delivered to all enrolled participants after consent and baseline assessment and before allocation is revealed. One individual face-to-face session lasting approximately 3-5 minutes using a condensed 5A framework (Ask, Advise, Assess, Assist, Arrange).
Only participants randomized to the intervention arm are offered one additional individual face-to-face CBT-based smoking-cessation session lasting approximately 20-30 minutes after allocation. Six modules address smoking-related cognitions/beliefs, cognitive restructuring, individualized quit goal/date/plan, triggers/high-risk situations, coping for cravings/withdrawal/stress, and relapse-prevention/lapse management. Delivery is standardized and fidelity is recorded.
Self-Reported 7-Day Point-Prevalence Cigarette Smoking Abstinence at 3 Months
7-day point-prevalence cigarette smoking abstinence will be defined as self-report of no cigarette smoking, not even a puff, during the 7 days preceding the 3-month follow-up assessment. Participants reporting any cigarette smoking, even a puff, during this 7-day period will be classified as not abstinent. No biochemical verification.
Time frame: 3 months after randomization
Self-Reported 7-Day Point-Prevalence Cigarette Smoking Abstinence at 1 and 2 Months
Self-report of no cigarette smoking, not even a puff, during the 7 days preceding each follow-up assessment.
Time frame: 1 and 2 months after randomization.
: Self-Reported Sustained Cigarette Smoking Abstinence From Month 1 Through Month 3.
Sustained cigarette smoking abstinence will be defined as self-report of no cigarette smoking, not even a puff, from the Month 1 follow-up assessment through the Month 3 follow-up assessment, based on interval smoking assessments conducted at Months 2 and 3.
Time frame: From 1 month through 3 months after randomization
At least one intentional quit attempt lasting ≥24 hours during the 3-month follow-up.
An intentional quit attempt will be defined as a deliberate attempt to stop cigarette smoking that lasts at least 24 hours. Participants will be classified according to whether they report at least one such quit attempt during the 3-month follow-up period.
Time frame: From randomization through 3 months
Readiness/Commitment to Quit Cigarette Smoking
Readiness/commitment to quit cigarette smoking will be assessed using a 0-10 Visual Analogue Scale (VAS), with higher scores indicating greater readiness/commitment to quit. The VAS will be assessed at baseline and at the 1-, 2-, and 3-month follow-up assessments.
Time frame: Baseline and 1, 2, and 3 months after randomization
Plan to share: Yes — De-identified individual participant data underlying reported results may be made available upon reasonable request, subject to ethical requirements, institutional approval, and a data-sharing agreement.
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