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Can a short DBT program help cancer patients kick the habit?

NCT ID NCT07119489

Symptom relief Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This study is testing a short group therapy program based on Dialectical Behavior Therapy (DBT) to help cancer patients reduce or stop smoking. The program focuses on building skills in emotion regulation, distress tolerance, and mindfulness. The trial will enroll 16 participants and primarily measure whether the program is feasible and acceptable, not yet whether it definitively works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dialectical Behavior Therapy - Skills Training (behavioral counseling)
What this could lead to
If it works, this could offer a practical, short-term therapy to help cancer patients quit smoking, improving their overall health and treatment outcomes.
What could go wrong
This is a very small, early feasibility study with only 16 participants and no control group. It's designed to see if the approach is acceptable, not yet to prove it works. Results may not apply to all smokers with cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm Smoking

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Smoking behavior

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Levine Cancer

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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