A Novel Dialectical Behavior Therapy Brief Group Intervention for Cigarette Smoking by Patients With Cancer: An Open Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Recruitment Rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with cancer who smoke
Participants who smoke and are undergoing treatment with a curative intent for cancer or are in remission from cancer
干预措施: Dialectical Behavior Therapy -Skill Training brief intervention (Behavioral)
结局指标
主要结局
Recruitment Rates
时间窗: 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.
Acceptability of the DBT-ST brief intervention for cigarette smoking by patients with cancer
时间窗: 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
Feasibility of the DBT-ST brief intervention for cigarette smoking by patients with cancer
时间窗: 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
Fidelity of the DBT-ST brief intervention for cigarette smoking by patients with cancer
时间窗: 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
次要结局
- Cancer Patient Tobacco Use Questionnaire (C-TUQ)(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)(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)(Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.)
- Distress Tolerance Scale (DTS)(Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.)
- Serious quit attempts(Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.)
- Mindfulness Attention Awareness Scale (MAAS)(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(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)(Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks.)