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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smoking Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients with cancer who smoke

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

Group Type EXPERIMENTAL

Dialectical Behavior Therapy -Skill Training brief intervention

Intervention Type BEHAVIORAL

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

Interventions

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Dialectical Behavior Therapy -Skill Training brief intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 and are in active treatment with curative intent or in remission per enrolling investigator or electronic medical record.
4. Age ≥ 18 years at the time of consent.
5. Ability to understand and willingness to sign an IRB-approved informed consent, in English, directly.
6. 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. Life expectancy of six months or less.
4. Medical or psychiatric conditions limiting compliance with study requirements including suspected or reported cognitive impairment.
5. Self-reported use of any psychoactive substance \[except marijuana and nicotine\] within the last 30 days.
6. Have active and severe suicidal ideation at time of eligibility assessment or suicide attempt within the past month.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No