LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- PROMIS Anxiety Short Form (8a)
研究概览
简要总结
In this pilot randomized controlled trial, patients with metastatic non-small cell lung cancer and at least mild distress (N=80) will be randomized to receive LiveWell, an adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol) or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes). The investigators will explore emotion regulation as a potential mechanism of change.
详细描述
Participants will be randomized 1:1 to receive LiveWell, an eight-session, telehealth-delivered DBT Skills Training intervention tailored for lung cancer metavivors, or Usual Care. Participants will complete self-report measures at baseline, 9-week follow-up, and 3 month follow-up. It is hypothesized that: 1) RCT methods will demonstrate evidence of feasibility (accrual N=80/20 months, >80% adherence to assigned interventions and assessments, <25% attrition) and acceptability (>3/5 satisfaction study procedures, >3 mean intervention satisfaction LiveWell); 2) LiveWell participants will demonstrate reductions in emotional distress (primary outcome) and improvements in psychological well-being (illness acceptance, positive affect, tolerance of uncertainty, mindfulness, self-efficacy to manage emotions and symptoms), symptom burden (fatigue, dyspnea, pain), and quality of life (secondary outcomes) compared to Usual Care participants at 9-week follow-up. H3. (Exploratory). To explore the role of emotion regulation as a potential mechanism of change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •AJCC Stage IV non-small cell lung cancer
- •Receiving treatment with non-curative intent
- •English proficiency
- •Able to provide informed consent
- •National Comprehensive Cancer Network distress screening score ≥ 3/10
排除标准
- •Cognitive impairment
- •Untreated serious mental illness
- •Expected survival < 6 months
研究组 & 干预措施
LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program
Will receive 9 telehealth sessions delivered 1 on 1 via telehealth with a trained mental health professional. Sessions will be delivered approximately weekly and are 45-60 min in length. Sessions will teach skills from dialectical behavioral therapy (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) adapted for patients with metastatic lung cancer. Sessions follow a standardized structure, including 1) mindfulness practice, 2) home practice and diary card review, 3) learning and practicing new skills, and 4) closing ritual. Participants will have access to a resource library of skills training videos and mindfulness recordings.
干预措施: LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program (Behavioral)
Usual Care
Will receive a handout with general support resources available at Hollings Cancer Center.
结局指标
主要结局
PROMIS Anxiety Short Form (8a)
时间窗: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (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 anxiety symptomology.
PROMIS Depression Short Form (8a)
时间窗: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
Depression 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 depressive symptomology.
PROMIS Anxiety Short Form (8a)
时间窗: Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20)
Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (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 anxiety symptomology.
PROMIS Depression Short Form (8a)
时间窗: Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20)
Depression 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 depressive symptomology.
次要结局
- Intolerance of Uncertainty Scale - Short Form (IUS-12)(Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24))
- Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale(Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24))
- PROMIS Positive Affect Short Form (15a)(Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24))
- Difficulty in Regulating Emotions Scale (DERS-18)(Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24))
- Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)(Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24))
- PROMIS Self-Efficacy for Managing Symptoms Short Form (8a)(Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24))
- PROMIS Self-Efficacy for Managing Emotions (8a) Short Form(Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24))
- NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE)(Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24))
- Functional Assessment of Cancer Therapy - Lung (FACT-L)(Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24))
- DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS)(Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24))
- Intolerance of Uncertainty Scale - Short Form (IUS-12)(Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20))
- Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale(Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20))
- PROMIS Positive Affect Short Form (15a)(Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20))
- Difficulty in Regulating Emotions Scale (DERS-18)(Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20))
- Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)(Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20))
- PROMIS Self-Efficacy for Managing Symptoms Short Form (8a)(Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20))
- PROMIS Self-Efficacy for Managing Emotions (8a) Short Form(Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20))
- NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE)(Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20))
- Functional Assessment of Cancer Therapy - Lung (FACT-L)(Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20))
- DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS)(Baseline (week 0), post-intervention (week 8), and 3 month follow-up (week 20))
研究者
Kelly Hyland
Assistant Professor
Medical University of South Carolina