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

Not Applicable

Not yet recruiting

• Conditions: Smoking Behavior

• Registration Number: NCT07119489
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-08-18
• Primary Completion: 2026-11
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recruitment Rates	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.	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.
Acceptability of the DBT-ST brief intervention for cigarette smoking by patients with cancer	For each patient group, measured at weeks 1 through 8 of the intervention and at 1 month follow-up, assessed up to 100 weeks.	Quantitative (Likert scale) questions to assess patient experience of intervention
Feasibility of the DBT-ST brief intervention for cigarette smoking by patients with cancer	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.	Rate of completion of the eight proposed sessions by participants
Fidelity of the DBT-ST brief intervention for cigarette smoking by patients with cancer	Measured beginning 1 month after the date of week 8 of the final patient group participating in the intervention, assessed up to 6 months.	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

Secondary Outcome Measures

Name	Time	Method
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.	Changes in tobacco use, specifically number of days engaging in cigarette smoking (frequency) and number of cigarettes smoked per day (daily average) will be measured using the Cancer Patient Tobacco Use Questionnaire (C-TUQ) a 22-item self-report survey used to gather information about tobacco use by patients with cancer and cancer survivors.
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.	The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report Likert scale used to assess emotional regulation presented as a total score and 6 sub-scores including nonacceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity
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.	The DASS-21 is a 21-item self-report instrument designed to measure the three related negative emotional states of depression, anxiety, and tension/stress.
Distress Tolerance Scale (DTS)	Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.	Distress tolerance will be measured using the 15-item Distress Tolerance Scale (DTS). The DTS uses a 5-point Likert scale for participants to record responses to items (1 = 'Strongly Agree' to 5 = 'Strongly Disagree'). The total DTS score is calculated by adding the scores of all 15 items together after reverse-coding item 6 (score range 0-75)
Serious quit attempts	Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.	The period of intentional abstinence from smoking typically lasting at least 24 hours, to be collected by self-report using a single item Serious Quit Attempt questionnaire
Mindfulness Attention Awareness Scale (MAAS)	Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.	Mindfulness will be measured using the Mindfulness Attention Awareness Scale (MAAS), a 15-item self-report instrument designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present. The MAAS score is the mean of 15 Likert-scale items from 1-6 (score range 1-6)
Mental Adjustment to Cancer (MAC) Scale - Mini	Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.	The MAC-Mini is a 29-item self-rating scale to assess psychological dimensions of in cancer patients of helplessness/hopelessness, anxious preoccupation, fatalism, avoidance, and fighting spirit in their adjustment to the diagnosis and treatment of cancer. Higher scores reflect lower levels of adjustment for all subscales except fighting spirit, with a higher score indicating higher adjustment
DBT Ways of Coping Checklist (DBT-WCCL)	Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.	The DBT-WCCL is a 59-item self-report Likert scale, with one part assessing coping via DBT skills, the DBT Skills Subscale (DSS), and one part assessing coping via dysfunctional means, the Dysfunctional Coping Subscale (DCS).44 Skills use are measured on a scale from 0 (never used) to 3 (regularly used). Higher scores indicate more frequent use of DBT skills and functional coping behaviors.

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States