Smoking Cessation in Patients With Cancer

Effectiveness of a Cognitive Behavioral Therapy-Based Smoking Cessation Intervention Among Patients With Cancer at a Hospital in Vietnam

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Tobacco Use
• Intervention / Treatment: Behavioral: Standardized Brief Smoking-Cessation Counseling; Behavioral: Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling

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).

• Study Type: Interventional
• Enrollment (Estimated): 446
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nguyen Duc Khoa, MD, PhD; Phone Number: +84913022886; Email: khoa8668@gmail.com

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Vietnam National Cancer Hospital
    • Contact: Nguyen Duc Khoa, MD, PhD; Phone Number: +0084913022886; Email: khoa8668@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Standardized 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).
Experimental: 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.	Behavioral: Standardized 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).; Behavioral: Add-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported 7-Day Point-Prevalence Cigarette Smoking Abstinence at 3 Months	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.	3 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported 7-Day Point-Prevalence Cigarette 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.	1 and 2 months after randomization.
: Self-Reported Sustained Cigarette Smoking Abstinence From Month 1 Through Month 3.	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.	From 1 month through 3 months after randomization
At least one intentional quit attempt lasting ≥24 hours during the 3-month follow-up.	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.	From randomization through 3 months
Readiness/Commitment to Quit Cigarette Smoking	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.	Baseline and 1, 2, and 3 months after randomization

Collaborators and Investigators

• Sponsor: Nguyen Duc Khoa, MD, PhD
• Collaborators: Vietnam Tobacco Control Fund
• Investigators: Principal Investigator: Nguyen Duc Khoa, MD, PhD, Vietnam National Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: September 10, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Tobacco Use; Smoking Cessation; Cognitive Behavioral Therapy; Oncology Care
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Neoplasms; Smoking Cessation; Tobacco Use
• Other Study ID Numbers: TVCNTL.BVK.2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying reported results may be made available upon reasonable request, subject to ethical requirements, institutional approval, and a data-sharing agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No