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NCT07119489NARecruiting

A Novel Dialectical Behavior Therapy Brief Group Intervention for Cigarette Smoking by Patients With Cancer: An Open Clinical Trial

Wake Forest University Health Sciences

Start Date

2/11/2026

Completion Date

11/1/2026

Summary

The purpose of this research study is to learn more about how Dialectical Behavior Therapy - Skills Training can help patients with cancer who smoke cigarettes cut down on or stop their smoking.

Detailed Description

This is a study that aims to evaluate recruitment rates, feasibility, acceptability, and fidelity of Dialectical Behavior Therapy - Skills Training (DBT-ST) brief intervention. Study population will include participants who smoke and are undergoing treatment with curative intent for their cancer or are in remission. The study will include eight 60 minute sessions of DBT-ST and measurements of psychological states and smoking habits by interventionists. At follow-up participants will complete a survey on their intervention experience and ongoing use of DBT-ST. Interventionists will also complete a survey following each session to record time and materials use for future cost-effectiveness analysis. At follow-up, participants and interventionists will engage in a one-hour qualitative interview with a study team member.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Smoke ≥1 cigarettes every day in the past 30 days per participant report. 2. Smoked at least 100 cigarettes (5 packs) in lifetime. 3. Confirmation of cancer diagnosis at any time. 4. Patient encounter with an AHWFBCCC provider within the last two years. 5. Age ≥ 18 years at the time of consent. 6. Ability to understand and willingness to sign an IRB-approved informed consent, in English, directly. 7. Able and willing to participate in video conference. Exclusion Criteria: 1. Patients actively receiving external tobacco use counseling or using tobacco cessation medications. 2. Prior experience with more than five sessions of DBT-ST. 3. Medical or psychiatric conditions limiting compliance with study requirements including suspected or reported cognitive impairment. 4. Self-reported use of any psychoactive substance \[except marijuana and nicotine\] within the last 30 days. 5. Have active and severe suicidal ideation at time of eligibility assessment or suicide attempt within the past month.

Interventions

BEHAVIORAL

Dialectical Behavior Therapy -Skill Training brief intervention

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Conditions

Smoking Behavior

Locations

Atrium Health Levine Cancer

Charlotte, North Carolina 28204

United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina 27157

United States