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

Wake Forest University (WFU)

Status: Enrolling

Conditions: Smoking Behavior

Treatments: Behavioral: Dialectical Behavior Therapy -Skill Training brief intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07119489

ONC-CCS-2408 (Other Identifier)

IRB00131890

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Patients with cancer who smoke

Experimental group

Description:

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

Treatment:

Behavioral: Dialectical Behavior Therapy -Skill Training brief intervention