Cancer, Tobacco Use
Conditions
Keywords
Smoking Cessation, Smoking Relapse, Relapse Prevention, Cognitive Behavioral Therapy, Cancer, Tobacco Use, Oncology Care
Brief 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.
Detailed description
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).
Interventions
BEHAVIORALStandardized 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.
BEHAVIORALAdd-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.
Sponsors
Vietnam Tobacco Control Fund
Vietnam National Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor conducting follow-up telephone interviews will be blinded to participants' treatment allocation. Participants and intervention providers cannot be blinded because of the nature of the behavioral intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older. 2. Diagnosed with cancer. 3. Was smoking combustible cigarettes at the time of cancer diagnosis. 4. Has remained completely abstinent from cigarette smoking from the time of cancer diagnosis until study enrollment, without smoking even a puff. 5. Provides written informed consent to participate in the study.
Exclusion criteria
1. Have a medical, psychiatric, cognitive, hearing, speech, or other condition that prevents effective communication or meaningful participation in the counseling intervention or study assessments. 2. Are not expected to be contactable or able to complete the planned follow-up assessments. 3. Are currently using other combustible tobacco products, such as waterpipe tobacco, shisha/hookah, cigars, or pipes. 4. Are currently participating in another structured smoking-cessation intervention or clinical trial that could materially affect the study outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported 7-Day Point-Prevalence Smoking Abstinence at 3 Months | 3 months after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported 7-Day Point-Prevalence Smoking Abstinence at 1 and 2 Months | 1 and 2 months after randomization | Self-report of no cigarette smoking, not even a puff, during the 7 days preceding each follow-up assessment |
| Self-Reported Continuous Smoking Abstinence Through 3 Months | From randomization through 3 months | Self-report of no cigarette smoking, not even a puff, from randomization through the 3-month follow-up assessment. |
| Time to First Smoking Lapse | From randomization through 3 months | Time from randomization to the first self-reported cigarette smoking episode, even a puff. |
| Number of Smoking Days During Follow-up | From randomization through 3 months | Total number of days on which the participant smoked any cigarettes from randomization through 3 months. |
| Commitment to Maintaining Smoking Abstinence | Baseline, 1 month, 2 months, and 3 months after randomization | 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. |
Countries
Vietnam
Outcome results
None listed