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

NCT07119489 | Recruiting DMC

• 2 other identifiers: IRB00131890ONC-CCS-2408
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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

Keywords

Dialectical Behavior Therapy; Cancer; Smoking

Outcome Measures

Primary Outcomes (4)

• Recruitment Rates

  Ratio of patients enrolled in study to patients responding to advertisement or referred by providers, and ratio of patients enrolled to patients screened and potentially eligible for the study.

  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

  Rate of completion of the eight proposed sessions by participants

  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

  Quantitative (Likert scale) questions to assess patient experience of intervention

  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

  Interventionist adherence to intervention manual will be assessed by having an independent reviewer select 50% of the audiotaped group sessions (the total depends on the number of groups) and complete a checklist of 25 intervention items (yes/no) to see whether the interventionist performed the item

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

Secondary Outcomes (8)

• Cancer Patient Tobacco Use Questionnaire (C-TUQ)

  Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.

• Difficulties in Emotion Regulation Scale-36 (DERS-36)

  Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.

• Depression Anxiety Stress Scales-21 (DASS-21)

  Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.

• Distress Tolerance Scale (DTS)

  Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.

• Mindfulness Attention Awareness Scale (MAAS)

  Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.

Other Outcomes (4)

• Self-reported cost for interventionist and patient time and expenses

  Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.

• Costs of nicotine replacement therapy

  Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.

• Time between initial cancer diagnosis and administration of the DBT-ST intervention

  Measured from the date of initial cancer diagnosis until week 1 of the patient's participation in the intervention, assessed up to 100 weeks.

Study Arms (1)

Patients with cancer who smoke

EXPERIMENTAL

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

Behavioral: Dialectical Behavior Therapy -Skill Training brief intervention

Interventions

Dialectical Behavior Therapy -Skill Training brief intervention BEHAVIORAL

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

Patients with cancer who smoke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Have active and severe suicidal ideation at time of eligibility assessment or suicide attempt within the past month.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Wake Forest Baptist: collaborator

Study Sites (2)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Smoking; Neoplasms

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Marcia McCall, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Morgan

CONTACT

336-712-4491; jwmorgan@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 13, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)