Brief group Dialectical Behavior Therapy skills program to help people with cancer cut down or stop smoking

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

This study will try a short group Dialectical Behavior Therapy skills program to help adults with cancer who smoke cut down or quit.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 2 sites (Charlotte, North Carolina and 1 other locations)
• Trial ID: NCT07119489 on ClinicalTrials.gov

What this trial studies

Adults with a confirmed cancer diagnosis who smoke will be offered eight 60-minute group sessions teaching Dialectical Behavior Therapy skills delivered by trained interventionists. The team will track recruitment, feasibility, acceptability, and fidelity while measuring participants' smoking behavior and psychological states before, during, and after the intervention. Interventionists will record time and materials used for future cost-effectiveness estimates, and both participants and staff will complete surveys and one-hour qualitative interviews at follow-up. The protocol is framed as an open clinical trial to inform whether a brief DBT skills approach is practical and acceptable in cancer care settings.

Who should consider this trial

Good fit: Adults (age ≥18) with a confirmed cancer diagnosis who are in treatment with curative intent or in remission, who smoke at least one cigarette daily, can consent in English, and are able to join video conference sessions are ideal candidates.

Not a fit: Patients already receiving external tobacco counseling or using cessation medications, those with extensive prior DBT-ST experience, significant cognitive or psychiatric impairment, recent non-prescribed psychoactive drug use, active severe suicidal ideation, or inability to participate via video may not benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could provide a brief, group-based approach that helps adults with cancer reduce or stop smoking and is practical to deliver in oncology settings.

How similar studies have performed: DBT skills training has shown promise for improving emotion regulation and reducing some substance use, but brief DBT-ST specifically targeted at smoking among cancer patients is largely untested.

Eligibility criteria

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.

Where this trial is running

Charlotte, North Carolina and 1 other locations

• Atrium Health Levine Cancer — Charlotte, North Carolina, United States (Recruiting)
• Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Marcia McCall, PhD — Wake Forest University Health Sciences
• Study coordinator: James Morgan

Conditions Smoking Behavior; Dialectical Behavior Therapy; Cancer; Smoking