Smoking Cessation in Patients With Cancer

NCT07822464 | Not Yet Recruiting

• 1 other identifier: TVCNTL.BVK.2026
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Tobacco Use

Keywords

Smoking Cessation; Cognitive Behavioral Therapy; Cancer; Tobacco Use; Oncology Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Standardized Brief Smoking-Cessation Counseling Alone

ACTIVE COMPARATOR

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

Standardized Brief Smoking-Cessation Counseling Plus Structured CBT

EXPERIMENTAL

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; Behavioral: Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling

Interventions

Standardized Brief Smoking-Cessation Counseling BEHAVIORAL

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).

Standardized Brief Smoking-Cessation Counseling Alone; Standardized Brief Smoking-Cessation Counseling Plus Structured CBT

Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling BEHAVIORAL

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.

Standardized Brief Smoking-Cessation Counseling Plus Structured CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Clinically too severe for reliable participation.
• Cognitive/communication limitations precluding consent or reliable participation.
• Currently participating in a competing structured smoking-cessation program.

Sponsors & Collaborators

• Nguyen Duc Khoa, MD, PhD: lead
• Vietnam Tobacco Control Fund: collaborator

Study Sites (1)

Vietnam National Cancer Hospital

Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Neoplasms; Tobacco Use; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Nguyen Duc Khoa, MD, PhD

  Vietnam National Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nguyen Duc Khoa, MD, PhD

CONTACT

+84913022886; khoa8668@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Center for Training and Technical Transfer

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)