Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Feasibility as Measured by Study Accrual
研究概览
简要总结
Metastatic lung cancer patients experience significantly greater psychological distress (i.e., depression, anxiety) compared to other cancers. Psychological distress is as a prognostic indicator for worse clinical outcomes and poorer overall survival in cancer patients. Dialectical behavioral therapy (DBT) is a trans-diagnostic, evidence-based psychotherapy that teaches participants a core set of behavioral skills (distress tolerance, emotion regulation, mindfulness, interpersonal effectiveness) to cope more effectively with emotional and physical symptoms. The proposed study seeks to adapt and pilot test DBT skills training for patients with metastatic lung cancer using the ADAPT-ITT framework. Participants will be metastatic lung cancer patients who score >=3 on the National Comprehensive Cancer Network distress thermometer. Phase I aims to use focus groups and interviews with key stakeholders (metastatic lung cancer patients (N=20), thoracic oncology providers (N=6), clinicians with expertise in survivorship and behavioral symptom management (N=6)) to determine if and how DBT skills training must be modified for implementation with metastatic lung cancer patients. Adapted material will be reviewed by topical experts in DBT and implementation science to produce a manualized, adapted DBT skills training protocol for metastatic lung cancer patients (LiveWell). Phase II aims to pilot test LiveWell (N=30) to assess feasibility, acceptability, and examine pre-to-post intervention outcomes of psychological distress, (i.e., depression and anxiety) fatigue, dyspnea, pain, emotion regulation, tolerance of uncertainty, and DBT coping skill use. LiveWell will consist of coping skills training sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
- •be undergoing systemic treatment (chemotherapy, targeted therapy, and/or immunotherapy) for lung cancer at Duke Cancer Institute
- •score >3 on the National Comprehensive Cancer Network Distress Thermometer for distress over the past week (Range: 0-10)
- •be > 18 years of age
- •be able to understand, speak, and read English
- •be able to provide informed consent
排除标准
- •reported or suspected cognitive impairment subsequently informed by a Montreal Cognitive Assessment (MOCA) of <26
- •presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart, treating oncologist, or other medical provider
- •expected survival of 4 months or less
结局指标
主要结局
Feasibility as Measured by Study Accrual
时间窗: Post-intervention (approximately 8 weeks)
Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
Adherence as Measured by Number of Participants Who Completed All Intervention Sessions
时间窗: Post-intervention (approximately 8 weeks)
Adherence will be shown by at least 80% of intervention sessions completed.
Feasibility as Measured by Number of Participants Lost From the Study Over Time
时间窗: Post-intervention (approximately 8 weeks)
Treatment feasibility will be shown by no more than 25% study attrition.
Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)
时间窗: Post-intervention (approximately 8 weeks)
CSQ items are rated on a 4-point scale from 1 (quite dissatisfied) to 4 (very satisfied), then averaged to obtain an overall acceptability score. Acceptability was demonstrated by \>80% of participants reporting intervention satisfaction (an average CSQ score of 3 to 4). Reported as the number of participants who had an average CSQ score of 3 to 4.
Psychological Distress as Measured by the PROMIS Depression Short Form Scales
时间窗: Baseline, post-intervention (approximately week 0, week 8, week 12)
Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater distress.
Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales
时间窗: Baseline, post-intervention (approximately week 0, week 8, week 12)
Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (7 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater distress.
次要结局
- Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)(Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12))
- Change in Dyspnea(Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12))
- Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)(Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12))
- Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)(Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12))
- Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)(Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12))
- Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)(Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12))
- Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)(Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12))