RecruitingNot Applicable

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

United States16 participantsStarted 2026-02-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Smoke ≥1 cigarettes every day in the past 30 days per participant report.
. Smoked at least 100 cigarettes (5 packs) in lifetime.
. Confirmation of cancer diagnosis at any time.
. Patient encounter with an AHWFBCCC provider within the last two years.
. Age ≥ 18 years at the time of consent.
. Ability to understand and willingness to sign an IRB-approved informed consent, in English, directly.
. Able and willing to participate in video conference.

Exclusion criteria

. Patients actively receiving external tobacco use counseling or using tobacco cessation medications.
. Prior experience with more than five sessions of DBT-ST.
. Medical or psychiatric conditions limiting compliance with study requirements including suspected or reported cognitive impairment.
. Self-reported use of any psychoactive substance \[except marijuana and nicotine\] within the last 30 days.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment Rates

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Measured beginning 1 month after the date of week 8 of the final patient group participating in the intervention, assessed up to 6 months.

Trial details

NCT IDNCT07119489

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

James Morgan

336-712-4491 jwmorgan@wakehealth.edu

View on ClinicalTrials.gov More Smoking Behavior trials