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Smoking Relapse Prevention in Patients With Cancer
Sponsor: Vietnam National Cancer Hospital
Summary
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.
Official title: Effectiveness of a Cognitive Behavioral Therapy-Based Smoking Relapse Prevention Intervention Among Patients With Cancer at a Hospital in Vietnam
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
498
Start Date
2026-10-15
Completion Date
2027-07-17
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
Standardized Brief 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.
Add-on One-Session Structured CBT-Based Relapse-Prevention Counseling
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.
Locations (1)
Vietnam National Cancer Hospital
Hà Nội, Vietnam