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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Dialectical Behavior Therapy -Skill Training brief intervention
  A behavioral counseling approach for enhancing skills in emotion regulation, distress tolerance, and mindfulness

Первичные конечные точки

• Recruitment Rates [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Measured beginning 1 month after the date of week 8 of the final patient group participating in the intervention, assessed up to 6 months.]

Вторичные конечные точки (8)

• Cancer Patient Tobacco Use Questionnaire (C-TUQ) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.]
• Distress Tolerance Scale (DTS) [Срок оценки: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.]
• Mindfulness Attention Awareness Scale (MAAS) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.]
• Serious quit attempts [Срок оценки: Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Atrium Health Levine Cancer — Charlotte
• Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Идентификаторы

NCT: NCT07119489 · IRB00131890 · P30CA012197 · ONC-CCS-2408

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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