CancerNCT07815912
Smoking Relapse Prevention in Patients With Cancer
A study testing Standardized Brief Relapse-Prevention Counseling and Add-on One-Session Structured CBT-Based Relapse-Prevention Counseling in people with Cancer and Tobacco Use, run by Vietnam National Cancer Hospital at 1 site in Vietnam.
Trial summary
This randomized controlled trial will evaluate whether adding one-session structured cognitive behavioral therapy (CBT)-based relapse-prevention counseling to standardized brief relapse-prevention counseling improves smoking abstinence among patients with cancer who smoked cigarettes at diagnosis and have remained… 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 Relapse-Prevention Counseling and Add-on One-Session Structured CBT-Based Relapse-Prevention Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Oct 2026to 17 Jul 2027
- Phase
- Interventional
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.
- Has remained completely abstinent from cigarette smoking from the time of cancer diagnosis until study enrollment, without smoking even a puff.
- Provides written informed consent to participate in the study.
Who cannot join
- Have a medical, psychiatric, cognitive, hearing, speech, or other condition that prevents effective communication or meaningful participation in the counseling intervention or study assessments.
- Are not expected to be contactable or able to complete the planned follow-up assessments.
- Are currently using other combustible tobacco products, such as waterpipe tobacco, shisha/hookah, cigars, or pipes.
- Are currently participating in another structured smoking-cessation intervention or clinical trial that could materially affect the study outcomes.
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
Hà Nội, 100000
Nguyễn Đức Khoa, MD, PhD, 0913022886, khoa8668@gmail.com
About this study
Official title: Effectiveness of a Cognitive Behavioral Therapy-Based Smoking Relapse Prevention 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 relapse-prevention counseling to standardized brief relapse-prevention counseling improves smoking abstinence among patients with cancer who smoked cigarettes at diagnosis and have remained completely abstinent from diagnosis until enrollment. After written consent and baseline assessment, all participants will receive the same standardized brief relapse-prevention counseling. Participants will then be randomly assigned 1:1 to no additional study CBT or to one additional structured CBT-based relapse-prevention 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
Smoking cessation after a cancer diagnosis is clinically important, but initial abstinence may not be sustained. This study is a randomized, two-arm, parallel-group superiority trial evaluating the incremental effect of structured CBT-based relapse-prevention counseling when added to standardized brief relapse-prevention counseling. Eligible participants smoked cigarettes at cancer diagnosis and have remained completely abstinent, without even a puff, from diagnosis until enrollment.
After eligibility confirmation, written informed consent, and baseline assessment, every enrolled participant will receive one standardized individual face-to-face brief relapse-prevention counseling session lasting approximately 3-5 minutes, adapted from the 5A framework for people who are already abstinent. 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 relapse-prevention 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 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 498 participants (249 per arm).
- Conditions
- Cancer, Tobacco Use
- Being tested
- Standardized Brief Relapse-Prevention Counseling, Add-on One-Session Structured CBT-Based Relapse-Prevention Counseling
- Keywords
- Smoking Cessation, Smoking Relapse, Relapse Prevention, 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 Relapse-Prevention 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, adapted from 5A for participants already abstinent: confirm abstinence; reinforce cessation; advise continued complete abstinence/not even a puff; briefly assess relapse risk; provide basic assistance/support; and explain follow-up. This is not a full smoking-cessation 5A workflow and does not include structured 5R.
Add-on One-Session Structured CBT-Based Relapse-Prevention CounselingBehavioural
Only participants randomized to the intervention arm are offered one additional individual face-to-face CBT-based relapse-prevention session lasting approximately 20-30 minutes after allocation. Six modules address maladaptive smoking-related thoughts/beliefs, cognitive restructuring, triggers/high-risk situations, coping with cravings/stress, individualized relapse-prevention planning, and lapse management/return to abstinence. Delivery is standardized and fidelity is recorded.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Brief Relapse-Prevention Counseling Alone | Active comparator | Before randomization, all participants receive the same individual face-to-face standardized brief relapse-prevention counseling session lasting approximately 3-5 minutes, adapted from the 5A framework for participants already abstinent. 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 Relapse-Prevention Counseling |
| Standardized Brief Relapse-Prevention Counseling Plus Structured CBT | Experimental | Before randomization, all participants receive the same standardized brief relapse-prevention counseling. After randomization, participants allocated to the intervention arm are offered one additional individual structured CBT-based relapse-prevention counseling session lasting approximately 20-30 minutes. The CBT addresses smoking-related cognitions, triggers/high-risk situations, coping, individualized relapse-prevention planning, and lapse management. Declining CBT after randomization does not change randomized assignment; follow-up continues if the participant agrees. Receives: Behavioral: Standardized Brief Relapse-Prevention Counseling; Behavioral: Add-on One-Session Structured CBT-Based Relapse-Prevention Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported 7-Day Point-Prevalence Smoking Abstinence at 3 Months
7-day point-prevalence 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.
Measured: 3 months after randomization
Secondary outcomes (5)
Self-Reported 7-Day Point-Prevalence 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 Continuous Smoking Abstinence Through 3 Months
Self-report of no cigarette smoking, not even a puff, from randomization through the 3-month follow-up assessment.
Measured: From randomization through 3 months
Time to First Smoking Lapse
Time from randomization to the first self-reported cigarette smoking episode, even a puff.
Measured: From randomization through 3 months
Number of Smoking Days During Follow-up
Total number of days on which the participant smoked any cigarettes from randomization through 3 months.
Measured: From randomization through 3 months
Commitment to Maintaining Smoking Abstinence
Commitment to maintaining smoking abstinence will be assessed using a 0-10 Visual Analogue Scale (VAS), with higher scores indicating greater commitment to maintaining complete smoking abstinence.
Measured: Baseline, 1 month, 2 months, 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 posted11 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion17 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vietnam National Cancer Hospital
- Collaborators
- Vietnam Tobacco Control Fund
- Responsible party
- Principal investigator, Nguyen Duc Khoa, MD, PhD, Vietnam National Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815912
- Sponsor's protocol ID
- TVTNTL.BVK.2026
- Status last verified
- Oct 2026
- First submitted
- 6 Sep 2026
- Last updated
- 21 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 the results reported in publications from the study may be made available upon reasonable request, subject to applicable ethical requirements, institutional approval, and a data-sharing agreement.