Recruiting

Dialectical Behavior Therapy

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07119489

Conditions

Smoking Behavior

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dialectical Behavior Therapy -Skill Training brief intervention

Study Details

Brief 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.

Conditions

Smoking Behavior

Study ID

NCT07119489

Start date

Feb 11, 2026

Status verified date

Jul, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Patients with cancer who smoke

Participants who smoke and are undergoing treatment with a curative intent for cancer or are in remission from cancer

Interventions

Dialectical Behavior Therapy -Skill Training brief intervention

A behavioral counseling approach for enhancing skills in emotion regulation, distress tolerance, and mindfulness

Primary outcome measure

  • Recruitment Rates [ Time Frame: Measured from the date the first patient responds to advertisement or is referred to the study by providers until the date the last patient group begins the first session of the intervention, assessed up to 100 weeks. ]
  • Feasibility of the DBT-ST brief intervention for cigarette smoking by patients with cancer [ Time Frame: Measured from the date the first patient group begins the first session of the intervention until the date the last patient group completes the eighth session of the intervention, assessed up to 100 weeks. ]
  • Acceptability of the DBT-ST brief intervention for cigarette smoking by patients with cancer [ Time Frame: For each patient group, measured at weeks 1 through 8 of the intervention and at 1 month follow-up, assessed up to 100 weeks. ]
  • Fidelity of the DBT-ST brief intervention for cigarette smoking by patients with cancer [ Time Frame: Measured beginning 1 month after the date of week 8 of the final patient group participating in the intervention, assessed up to 6 months. ]

Central Contacts and Locations

Central contacts

James Morgan

336-712-4491jwmorgan@wakehealth.edu

Locations

Atrium Health Levine Cancer

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Boris Kiselev, MD

704-355-2000boris.kiselev@advocatehealth.org

Principal Investigator:

Boris Kiselev, MD

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

James Morgan

336-712-4491jwmorgan@wakehealth.edu

Principal Investigator:

Marcia McCall, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Dialectical Behavior Therapy
  • Cancer
  • Smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-06.