Cancer, Tobacco Use
Conditions
Keywords
Smoking Cessation, 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 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.
Detailed description
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).
Interventions
BEHAVIORALStandardized Brief 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).
BEHAVIORALAdd-on One-Session Structured CBT-Based Smoking-Cessation Counseling
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.
Sponsors
Nguyen Duc Khoa, MD, PhD
Vietnam Tobacco Control Fund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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. Still smoking combustible cigarettes at screening/enrollment. 5. Able to communicate sufficiently and provide reliable study information. 6. Provides written informed consent.
Exclusion criteria
1. Clinically too severe for reliable participation. 2. Cognitive/communication limitations precluding consent or reliable participation. 3. Currently participating in a competing structured smoking-cessation program. 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported 7-Day Point-Prevalence Cigarette Smoking Abstinence at 3 Months | 3 months after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported 7-Day Point-Prevalence Cigarette 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 Sustained Cigarette Smoking Abstinence From Month 1 Through Month 3. | From 1 month through 3 months after randomization | 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. |
| At least one intentional quit attempt lasting ≥24 hours during the 3-month follow-up. | From randomization through 3 months | 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. |
| Readiness/Commitment to Quit Cigarette Smoking | Baseline and 1, 2, and 3 months after randomization | 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. |
Countries
Vietnam
Contacts
CONTACTNguyen Duc Khoa, MD, PhD
PRINCIPAL_INVESTIGATORNguyen Duc Khoa, MD, PhD
Vietnam National Cancer Hospital
Outcome results
None listed