Actively Recruiting
A Novel Dialectical Behavior Therapy Brief Group Intervention for Cigarette Smoking by Patients With Cancer: An Open Clinical Trial
Led by Wake Forest University Health Sciences · Updated on 2026-05-26
16
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
A
Atrium Health Wake Forest Baptist
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how Dialectical Behavior Therapy - Skills Training (DBT-ST) can help patients with cancer who smoke cigarettes reduce or stop smoking. This research aims to evaluate how well patients can be recruited, the feasibility, acceptability, and proper use of this brief behavioral counseling approach among cancer patients undergoing treatment or in remission. The study focuses on improving skills in emotion regulation, distress tolerance, and mindfulness to support smoking cessation efforts. Participants will receive eight weekly group sessions of DBT-ST, each lasting 60 minutes, delivered via video conferencing. During the intervention, psychological states and smoking habits will be assessed by interventionists. After completing the sessions, participants will fill out surveys about their experience and ongoing use of DBT-ST skills. Interventionists will also record session details for future analysis. At follow-up, both participants and interventionists will take part in a one-hour interview to discuss the intervention. Throughout the study, researchers will measure recruitment rates from the first patient responding to referrals or advertisements until the last group begins. Feasibility, acceptability, and fidelity of the intervention will be assessed during and after the 8-session program, including follow-up at one month. Various psychological and smoking-related questionnaires will be administered at baseline, mid-intervention, end of intervention, and follow-up to monitor changes. The study is expected to last up to 100 weeks for recruitment and intervention, with fidelity assessed up to six months after the final session.
CONDITIONS
Brief Title
A Novel Dialectical Behavior Therapy Brief Group Intervention for Cigarette Smoking by Patients With Cancer: An Open Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Smoke at least 1 cigarette every day in the past 30 days
- Smoked at least 100 cigarettes (5 packs) in lifetime
- Confirmed cancer diagnosis at any time
- Patient encounter with an AHWFBCCC provider within the last two years
- Age 18 years or older at the time of consent
- Ability to understand and willing to sign informed consent in English
- Able and willing to participate in video conference sessions
You will not qualify if you...
- Currently receiving external tobacco use counseling or using tobacco cessation medications
- Prior experience with more than five sessions of Dialectical Behavior Therapy - Skills Training
- 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
- Active and severe suicidal ideation at eligibility assessment or suicide attempt within the past month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - 8 weeks
Participants attend eight 60-minute group sessions of Dialectical Behavior Therapy - Skills Training (DBT-ST) to enhance skills in emotion regulation, distress tolerance, and mindfulness.
8 weekly group sessions via video conference
Duration - 1 month after treatment completion
Participants complete surveys and a one-hour qualitative interview about their experience and ongoing use of DBT-ST. Interventionists also complete surveys for cost-effectiveness analysis.
1 survey and 1 interview session (virtual)
Trial Site Locations
Total: 2 locations
1
Atrium Health Levine Cancer
Charlotte, North Carolina, United States, 28204
Actively Recruiting
2
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
J
James Morgan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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