Smoking BehaviorNCT07119489
A Novel Dialectical Behavior Therapy Brief Group Intervention for Cigarette Smoking by Patients With Cancer: An Open Clinical Trial
A study testing Dialectical Behavior Therapy -Skill Training brief intervention in people with Smoking Behavior, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Behavior
- What is being tested?
- Dialectical Behavior Therapy -Skill Training brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Smoking Behavior
- Being tested
- Dialectical Behavior Therapy -Skill Training brief intervention
- Keywords
- Dialectical Behavior Therapy, Cancer, Smoking
- Medical subject headings
- Smoking, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior Therapy -Skill Training brief interventionBehavioural
A behavioral counseling approach for enhancing skills in emotion regulation, distress tolerance, and mindfulness
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Dialectical Behavior Therapy -Skill Training brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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
Measured: 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: 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)
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.
Measured: 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)
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
Measured: 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)
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.
Measured: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
Distress Tolerance Scale (DTS)
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)
Measured: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
Mindfulness Attention Awareness Scale (MAAS)
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)
Measured: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
Mental Adjustment to Cancer (MAC) Scale - Mini
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
Measured: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
DBT Ways of Coping Checklist (DBT-WCCL)
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.
Measured: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
Serious quit attempts
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
Measured: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start11 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marcia McCall, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119489
- Sponsor's protocol ID
- IRB00131890
- Other IDs
- P30CA012197, ONC-CCS-2408
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Dialectical Behavior Therapy Brief Group Intervention for Cigarette Smoking by Patients With Cancer: An Open Clinical Trial
- ClinicalTrials.gov ID
- NCT07119489
- Acronym / sponsor ID
- IRB00131890
- Conditions
- Smoking Behavior
- Keywords
- Dialectical Behavior Therapy, Cancer, Smoking
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist, National Cancer Institute (NCI)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer who smoke | Experimental | Behavioral: Dialectical Behavior Therapy -Skill Training brief interventionParticipants who smoke and are undergoing treatment with a curative intent for cancer or are in remission from cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavior Therapy -Skill Training brief interventionA behavioral counseling approach for enhancing skills in emotion regulation, distress tolerance, and mindfulness | Behavioural | Patients with cancer who smoke |
Primary outcome
Recruitment Rates
Time frame: 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.
Feasibility of the DBT-ST brief intervention for cigarette smoking by patients with cancer
Time frame: 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
Acceptability of the DBT-ST brief intervention for cigarette smoking by patients with cancer
Time frame: 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
Fidelity of the DBT-ST brief intervention for cigarette smoking by patients with cancer
Time frame: 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
8 secondary outcomes
Cancer Patient Tobacco Use Questionnaire (C-TUQ)
Time frame: 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)
Time frame: 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)
Time frame: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
Distress Tolerance Scale (DTS)
Time frame: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
Mindfulness Attention Awareness Scale (MAAS)
Time frame: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
Mental Adjustment to Cancer (MAC) Scale - Mini
Time frame: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
DBT Ways of Coping Checklist (DBT-WCCL)
Time frame: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
Serious quit attempts
Time frame: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia McCall, PhD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavior Therapy -Skill Training brief intervention in people with Smoking Behavior, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rates (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.