CancerNCT07822464
Smoking Cessation in Patients With Cancer
A study testing Standardized Brief Smoking-Cessation Counseling and Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling in people with Cancer and Tobacco Use, run by Nguyen Duc Khoa, MD, PhD at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Tobacco Use
- What is being tested?
- Standardized Brief Smoking-Cessation Counseling and Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Oct 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Vietnam National Cancer Hospital
Hanoi, 100000
Nguyen Duc Khoa, MD, PhD, +0084913022886, khoa8668@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Cancer, Tobacco Use
- Being tested
- Standardized Brief Smoking-Cessation Counseling, Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling
- Keywords
- Smoking Cessation, Cognitive Behavioral Therapy, Cancer, Tobacco Use, Oncology Care
- Medical subject headings
- Neoplasms, Tobacco Use, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Brief Smoking-Cessation CounselingBehavioural
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standardized Brief Smoking-Cessation Counseling; Behavioral: Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after randomization
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1, 2, and 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 446 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nguyen Duc Khoa, MD, PhD
- Collaborators
- Vietnam Tobacco Control Fund
- Responsible party
- Sponsor-investigator, Nguyen Duc Khoa, MD, PhD, Vietnam National Cancer Hospital
- Investigators
- Nguyen Duc Khoa, MD, PhD, Principal investigator, Vietnam National Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822464
- Sponsor's protocol ID
- TVCNTL.BVK.2026
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Cognitive Behavioral Therapy-Based Smoking Cessation Intervention Among Patients With Cancer at a Hospital in Vietnam
- ClinicalTrials.gov ID
- NCT07822464
- Acronym / sponsor ID
- TVCNTL.BVK.2026
- Conditions
- Cancer, Tobacco Use
- Keywords
- Smoking Cessation, Cognitive Behavioral Therapy, Cancer, Tobacco Use, Oncology Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 446 participants (estimated)
- Lead sponsor
- Nguyen Duc Khoa, MD, PhD
- Collaborators
- Vietnam Tobacco Control Fund
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Brief Smoking-Cessation Counseling Alone | Active comparator | Behavioral: Standardized Brief Smoking-Cessation CounselingBefore 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. |
| Standardized Brief Smoking-Cessation Counseling Plus Structured CBT | Experimental | Behavioral: Standardized Brief Smoking-Cessation Counseling, Behavioral: Add-on One-Session Structured CBT-Based Smoking-Cessation CounselingBefore 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Brief Smoking-Cessation CounselingCommon 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). | Behavioural | Standardized Brief Smoking-Cessation Counseling Alone, Standardized Brief Smoking-Cessation Counseling Plus Structured CBT |
| Add-on One-Session Structured CBT-Based Smoking-Cessation CounselingOnly 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. | Behavioural | Standardized Brief Smoking-Cessation Counseling Plus Structured CBT |
Primary outcome
Self-Reported 7-Day Point-Prevalence Cigarette Smoking Abstinence at 3 Months
Time frame: 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.
4 secondary outcomes
Self-Reported 7-Day Point-Prevalence Cigarette Smoking Abstinence at 1 and 2 Months
Time frame: 1 and 2 months after randomization.
: Self-Reported Sustained Cigarette Smoking Abstinence From Month 1 Through Month 3.
Time frame: From 1 month through 3 months after randomization
At least one intentional quit attempt lasting ≥24 hours during the 3-month follow-up.
Time frame: From randomization through 3 months
Readiness/Commitment to Quit Cigarette Smoking
Time frame: Baseline and 1, 2, and 3 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nguyen Duc Khoa, MD, PhD principal investigator
Vietnam National Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Brief Smoking-Cessation Counseling and Add-on One-Session Structured CBT-Based Smoking-Cessation Counseling in people with Cancer and Tobacco Use, run by Nguyen Duc Khoa, MD, PhD at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nguyen Duc Khoa, MD, PhD (+84913022886, khoa8668@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported 7-Day Point-Prevalence Cigarette Smoking Abstinence at 3 Months (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.