Effectiveness of a Cognitive Behavioral Therapy-Based Smoking Cessation Intervention Among Patients With Cancer at a Hospital in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 446
- 试验地点
- 1
- 主要终点
- Self-Reported 7-Day Point-Prevalence Cigarette Smoking Abstinence at 3 Months
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Diagnosed with cancer.
- •Was smoking combustible cigarettes at the time of cancer diagnosis.
- •Still smoking combustible cigarettes at screening/enrollment.
- •Able to communicate sufficiently and provide reliable study information.
- •Provides written informed consent.
排除标准
- •Clinically too severe for reliable participation.
- •Cognitive/communication limitations precluding consent or reliable participation.
- •Currently participating in a competing structured smoking-cessation program.
- •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.
研究组 & 干预措施
Standardized Brief Smoking-Cessation Counseling Alone
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.
干预措施: Standardized Brief Smoking-Cessation Counseling (Behavioral)
Standardized Brief Smoking-Cessation Counseling Plus Structured CBT
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.
干预措施: Standardized Brief Smoking-Cessation Counseling (Behavioral)
Standardized Brief Smoking-Cessation Counseling Plus Structured CBT
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.
干预措施: Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling (Behavioral)
结局指标
主要结局
Self-Reported 7-Day Point-Prevalence Cigarette Smoking Abstinence at 3 Months
时间窗: 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.
次要结局
- Self-Reported 7-Day Point-Prevalence Cigarette Smoking Abstinence at 1 and 2 Months(1 and 2 months after randomization.)
- : Self-Reported Sustained Cigarette Smoking Abstinence From Month 1 Through Month 3.(From 1 month through 3 months after randomization)
- At least one intentional quit attempt lasting ≥24 hours during the 3-month follow-up.(From randomization through 3 months)
- Readiness/Commitment to Quit Cigarette Smoking(Baseline and 1, 2, and 3 months after randomization)
研究者
Nguyen Duc Khoa, MD, PhD
Director of Center for Training and Technical Transfer
Vietnam National Cancer Hospital