Clinical trial · Interventional
Smoking Relapse Prevention in Patients With Cancer
Effectiveness of a Cognitive Behavioral Therapy-Based Smoking Relapse Prevention Intervention Among Patients With Cancer at a Hospital in Vietnam
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Tobacco Use | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Add-on One-Session Structured CBT-Based Relapse-Prevention Counseling | Behavioral | — | UNRESOLVED |
| Standardized Brief Relapse-Prevention Counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standardized Brief Relapse-Prevention Counseling Alone
- description
- 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.
- interventionNames
- Behavioral: Standardized Brief Relapse-Prevention Counseling
- type
- EXPERIMENTAL
- label
- Standardized Brief Relapse-Prevention Counseling Plus Structured CBT
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 years or older. 2. Diagnosed with cancer. 3. Was smoking combustible cigarettes at the time of cancer diagnosis. 4. Has remained completely abstinent from cigarette smoking from the time of cancer diagnosis until study enrollment, without smoking even a puff. 5. Provides written informed consent to participate in the study. Exclusion Criteria: 1. Have a medical, psychiatric, cognitive, hearing, speech, or other condition that prevents effective communication or meaningful participation in the counseling intervention or study assessments. 2. Are not expected to be contactable or able to complete the planned follow-up assessments. 3. Are currently using other combustible tobacco products, such as waterpipe tobacco, shisha/hookah, cigars, or pipes. 4. Are currently participating in another structured smoking-cessation intervention or clinical trial that could materially affect the study outcomes.
References
Publications (0)
Data not yet available