An interventional study of Standardized Brief Relapse-Prevention Counseling and Add-on One-Session Structured CBT-Based Relapse-Prevention Counseling in Cancer and Tobacco Use, sponsored by Vietnam National Cancer Hospital. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Vietnam National Cancer Hospital · Not applicable, Interventional, and Prevention
This randomized controlled trial will evaluate whether adding one-session structured cognitive behavioral therapy (CBT)-based relapse-prevention counseling to standardized brief relapse-prevention counseling improves smoking abstinence among patients with cancer who smoked cigarettes at diagnosis and have remained completely abstinent from diagnosis until enrollment. After written consent and baseline assessment, all participants will receive the same standardized brief relapse-prevention counseling. Participants will then be randomly assigned 1:1 to no additional study CBT or to one additional structured CBT-based relapse-prevention session. Follow-up will continue for 3 months after randomization at Campus 3 of Vietnam National Cancer Hospital in Hanoi, Vietnam.
Smoking cessation after a cancer diagnosis is clinically important, but initial abstinence may not be sustained. This study is a randomized, two-arm, parallel-group superiority trial evaluating the incremental effect of structured CBT-based relapse-prevention counseling when added to standardized brief relapse-prevention counseling. Eligible participants smoked cigarettes at cancer diagnosis and have remained completely abstinent, without even a puff, from diagnosis until enrollment.
After eligibility confirmation, written informed consent, and baseline assessment, every enrolled participant will receive one standardized individual face-to-face brief relapse-prevention counseling session lasting approximately 3-5 minutes, adapted from the 5A framework for people who are already abstinent. 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 relapse-prevention 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 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 498 participants (249 per arm).
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 498 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Vietnam National Cancer Hospital as lead sponsor.
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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 relapse-prevention counseling session lasting approximately 3-5 minutes, adapted from the 5A framework for participants already abstinent. 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 Relapse-Prevention Counseling
Before randomization, all participants receive the same standardized brief relapse-prevention counseling. After randomization, participants allocated to the intervention arm are offered one additional individual structured CBT-based relapse-prevention counseling session lasting approximately 20-30 minutes. The CBT addresses smoking-related cognitions, triggers/high-risk situations, coping, individualized relapse-prevention planning, and lapse management. Declining CBT after randomization does not change randomized assignment; follow-up continues if the participant agrees.
Behavioral: Standardized Brief Relapse-Prevention Counseling · Behavioral: Add-on One-Session Structured CBT-Based Relapse-Prevention 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, adapted from 5A for participants already abstinent: confirm abstinence; reinforce cessation; advise continued complete abstinence/not even a puff; briefly assess relapse risk; provide basic assistance/support; and explain follow-up. This is not a full smoking-cessation 5A workflow and does not include structured 5R.
Only participants randomized to the intervention arm are offered one additional individual face-to-face CBT-based relapse-prevention session lasting approximately 20-30 minutes after allocation. Six modules address maladaptive smoking-related thoughts/beliefs, cognitive restructuring, triggers/high-risk situations, coping with cravings/stress, individualized relapse-prevention planning, and lapse management/return to abstinence. Delivery is standardized and fidelity is recorded.
Self-Reported 7-Day Point-Prevalence Smoking Abstinence at 3 Months
7-day point-prevalence 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.
Time frame: 3 months after randomization
Self-Reported 7-Day Point-Prevalence 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 Continuous Smoking Abstinence Through 3 Months
Self-report of no cigarette smoking, not even a puff, from randomization through the 3-month follow-up assessment.
Time frame: From randomization through 3 months
Time to First Smoking Lapse
Time from randomization to the first self-reported cigarette smoking episode, even a puff.
Time frame: From randomization through 3 months
Number of Smoking Days During Follow-up
Total number of days on which the participant smoked any cigarettes from randomization through 3 months.
Time frame: From randomization through 3 months
Commitment to Maintaining Smoking Abstinence
Commitment to maintaining smoking abstinence will be assessed using a 0-10 Visual Analogue Scale (VAS), with higher scores indicating greater commitment to maintaining complete smoking abstinence.
Time frame: Baseline, 1 month, 2 months, and 3 months after randomization
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications from the study may be made available upon reasonable request, subject to applicable ethical requirements, institutional approval, and a data-sharing agreement.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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