About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Dialectical Behavior Therapy -Skill Training brief intervention
BehavioralA behavioral counseling approach for enhancing skills in emotion regulation, distress tolerance, and mindfulness
Treatment groups
Trial outcomes
Primary outcomes
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.
Feasibility of the DBT-ST brief intervention for cigarette smoking by patients with cancer
Rate of completion of the eight proposed sessions by participants
Acceptability of the DBT-ST brief intervention for cigarette smoking by patients with cancer
Quantitative (Likert scale) questions to assess patient experience of intervention
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
Secondary outcomes
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.
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
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.
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)
Other outcomes
Self-reported cost for interventionist and patient time and expenses
Self-reported cost for interventionist and patient time and expenses will be collected using an interventionist questionnaire
Costs of nicotine replacement therapy
Costs of nicotine replacement therapy will be captured using a single item added to the Cancer Patient Tobacco Use Questionnaire (item 15a)
Time between initial cancer diagnosis and administration of the DBT-ST intervention
The impact on smoking cessation or reduction of the length of time between initial cancer diagnosis and administration of the DBT-ST intervention will be measured using the initial diagnosis date of any cancer per the patient's electronic health record and the Cancer Patient Tobacco Use Questionnaire
Group Size
The impact of group size on outcomes will be measured using the number of persons in each group, provided group size varies
Sponsors and contacts
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Wake Forest University Health Sciences
Lead sponsor
Atrium Health Wake Forest Baptist
Collaborator
National Cancer Institute (NCI)
Collaborator