Smoking Relapse Prevention in Patients With Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVietnam National Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Standardized Brief Relapse-Prevention Counseling
BehavioralCommon 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 Counseling
BehavioralOnly 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.
Treatment groups
498 Participants
are divided into 2 treatment groupsGroup A: Standardized Brief Relapse-Prevention Counseling AloneActive comparator 1 intervention
Group B: Standardized Brief Relapse-Prevention Counseling Plus Structured CBTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months after randomizationSecondary outcomes
1
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
Time frame
1 and 2 months after randomization2
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.
Time frame
From randomization through 3 months3
Time to First Smoking Lapse
Time from randomization to the first self-reported cigarette smoking episode, even a puff.
Time frame
From randomization through 3 months4
Number of Smoking Days During Follow-up
Total number of days on which the participant smoked any cigarettes from randomization through 3 months.
Time frame
From randomization through 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vietnam National Cancer Hospital
Lead sponsor
Vietnam Tobacco Control Fund
Collaborator
Source ClinicalTrials.gov
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