Smoking Relapse Prevention in Patients With Cancer

NCT07815912 | Not Yet Recruiting

• 1 other identifier: TVTNTL.BVK.2026
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

Brief 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 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

Cancer; Tobacco Use

Keywords

Smoking Cessation; Smoking Relapse; Relapse Prevention; Cognitive Behavioral Therapy; Cancer; Tobacco Use; Oncology Care

Outcome Measures

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.

  3 months after randomization

Secondary Outcomes (5)

• Self-Reported 7-Day Point-Prevalence Smoking Abstinence at 1 and 2 Months

  1 and 2 months after randomization

• Self-Reported Continuous Smoking Abstinence Through 3 Months

  From randomization through 3 months

• Time to First Smoking Lapse

  From randomization through 3 months

• Number of Smoking Days During Follow-up

  From randomization through 3 months

• Commitment to Maintaining Smoking Abstinence

  Baseline, 1 month, 2 months, and 3 months after randomization

Study Arms (2)

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.

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.

Behavioral: Standardized Brief Relapse-Prevention Counseling; Behavioral: Add-on One-Session Structured CBT-Based Relapse-Prevention Counseling

Interventions

Standardized Brief Relapse-Prevention 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, 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.

Standardized Brief Relapse-Prevention Counseling Alone; Standardized Brief Relapse-Prevention Counseling Plus Structured CBT

Add-on One-Session Structured CBT-Based Relapse-Prevention Counseling BEHAVIORAL

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.

Standardized Brief Relapse-Prevention Counseling Plus Structured CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vietnam National Cancer Hospital: lead
• Vietnam Tobacco Control Fund: collaborator

Study Sites (1)

Vietnam National Cancer Hospital

Hà Nội, 100000, Vietnam

Location

MeSH Terms

Conditions

Neoplasms; Tobacco Use; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor conducting follow-up telephone interviews will be blinded to participants' treatment allocation. Participants and intervention providers cannot be blinded because of the nature of the behavioral intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Training and Technical Transfer Centre

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 11, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 17, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)