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临床试验/NCT06464562
NCT06464562已完成不适用

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer

Duke University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2025年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1
试验地点
1
主要终点
Usability as Measured by the Total Number of Participants Who Complete the Study Questionnaires

研究概览

简要总结

Patients are living longer with metastatic lung cancer (i.e., metavivors) due to therapeutic advances, but face significant challenges. Most metavivors will ultimately die of cancer and must navigate the duality of living while dying. Unsurprisingly, metavivors endorse high psychological distress (e.g., anxiety, depression, illness non-acceptance), high symptom burden (e.g., fatigue, dyspnea, pain), and poor quality of life. Psychosocial interventions can improve outcomes, but existing paradigms are not designed to help metavivors navigate the emotional turbulence of living with metastatic disease. Dialectical Behavioral Therapy (DBT) Skills Training is an evidence-based treatment that teaches patients transdiagnostic, easy-to-use skills to both accept things as they are (mindfulness, distress tolerance) and change things within their control (emotion regulation, interpersonal effectiveness) to better navigate life challenges. However, DBT Skills Training has rarely been applied in patients with chronic illness. The investigators adapted DBT Skills Training (e.g., intervention dose, delivery, content) for patients living with metastatic lung cancer to create LiveWell, an 8-session Skills Training protocol delivered one-on-one via videoconference. Building on preliminary data and aligned with the ORBIT model for behavioral intervention development, the first phase of this study (K99, Aim 1, 1 year) aims to iteratively refine LiveWell using 1) qualitative exit interview data from a proof-of-concept study, 2) an advisory board of interested parties, 3) the Dynamic Sustainability Framework from implementation science, and 4) user testing (n= up to 10). The K99 phase will produce a standardized protocol and procedures for the second, independent phase of the study (R00) which will be registered separately. If successful, LiveWell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm for other metavivors and patients with chronic illness.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
  • Undergoing lung cancer treatment with non-curative intent
  • Endorse >=3 out of 10 on the NCCN distress thermometer over the past week
  • At least 18 years of age
  • Able to understand, speak, and read English, and 5) be able to provide informed consent

排除标准

  • Reported or suspected cognitive impairment
  • Presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
  • Expected survival <6 months

研究组 & 干预措施

LiveWell: Adapted Dialectical Behavioral Therapy Skills Training

Experimental

Participants randomized to LiveWell will receive the refined intervention protocol as informed by Aim 1 (K99). LiveWell is an 8-session protocol of Dialectical Behavioral Therapy Skills Training, adapted specifically for patients with metastatic lung cancer. Sessions are delivered one on one via telehealth, approximately weekly. Participants learn concrete, easy-to-use skills to: 1) tune into the present moment, and how they are thinking and feeling (mindfulness), understand emotions, how to change them, and how to experience more positive feelings (emotion regulation), tolerate distressing emotions and symptoms (e.g., fatigue, pain, dyspnea) and to accept reality as it is (distress tolerance), and tools to communicate wants and needs effectively with others (interpersonal effectiveness). The goal is to teach patients skills to live well, with metastatic cancer. All sessions follow a standardized structure that is customary in skills training and grounded in social cognitive theory.

干预措施: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training (Behavioral)

结局指标

主要结局

Usability as Measured by the Total Number of Participants Who Complete the Study Questionnaires

时间窗: Up to 8 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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