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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Dialectical Behavior Therapy -Skill Training brief intervention

    Behavioral

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

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Patients with cancer who smokeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.
2

Feasibility of the DBT-ST brief intervention for cigarette smoking by patients with cancer

Rate of completion of the eight proposed sessions by participants

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.
3

Acceptability of the DBT-ST brief intervention for cigarette smoking by patients with cancer

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

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.
4

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

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.

Secondary outcomes

1

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.

Time frame
Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
2

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

Time frame
Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
3

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.

Time frame
Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
4

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)

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

Other outcomes

1

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

Time frame
Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
2

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 frame
Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.
3

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

Time frame
Measured from the date of initial cancer diagnosis until week 1 of the patient's participation in the intervention, assessed up to 100 weeks.
4

Group Size

The impact of group size on outcomes will be measured using the number of persons in each group, provided group size varies

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.

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