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Smoking Cessation in Patients With Cancer

ConditionsCancerTobacco Use
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNguyen Duc Khoa, MD, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

Treatment groups

446 Participants
are divided into 2 treatment groups
Group A: Standardized Brief Smoking-Cessation Counseling AloneActive comparator 1 intervention
Group B: Standardized Brief Smoking-Cessation Counseling Plus Structured CBTExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
3 months after randomization

Secondary outcomes

1

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.

Time frame
1 and 2 months after randomization.
2

: 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.

Time frame
From 1 month through 3 months after randomization
3

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.

Time frame
From randomization through 3 months
4

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.

Time frame
Baseline and 1, 2, and 3 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nguyen Duc Khoa, MD, PhD

Lead sponsor

Vietnam National Cancer Hospital

Sponsor institution

Vietnam Tobacco Control Fund

Collaborator

Source ClinicalTrials.gov

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