Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients

转移性肺癌患者经历显著更大的心理困扰（即，抑郁症， 与其他癌症相比。心理困扰是一个预后指标，更糟糕的临床 结果和癌症患者的总体生存率较差。由于其历史上预后不良， 转移性肺癌通常被排除在心理社会干预方案之外。现有的干预措施 没有解决导致这些患者心理困扰升高的因素，包括管理 高身体症状负担（疲劳，呼吸困难，疼痛），调节挑战性情绪（羞耻，内疚，恐惧）， 容忍未来的不确定性。辩证行为疗法（Dialectical Behavioral Therapy，DBT）是一种跨诊断、循证的治疗方法， 一种基于心理治疗的方法，教会参与者一套核心的行为技能（痛苦承受力、情感 调节，正念，人际交往的有效性），以更有效地科普情绪和身体 症状DBT技能培训已适用于各种临床人群，并已证明 减少心理困扰的功效。迄今为止，DBT技能培训尚未在以下患者中进行评估： 转移性肺癌患者将受益匪浅。我们预计DBT技能培训将需要 适于增加转移性肺癌患者的可接受性和相关性，包括1）递送， 2)剂量; 3）材料。拟议的研究旨在调整和试点测试DBT技能培训的患者， 使用ADAPT-ITT框架的转移性肺癌。参与者将是转移性肺癌患者 NCCN遇险温度计评分>3的人。第一阶段的目标是使用焦点小组和采访的关键 利益相关者（转移性肺癌患者（N=20）、胸部肿瘤提供者（N=6）、 生存率和行为症状管理方面的专业知识（N=6）），以确定DBT技能是否以及如何 必须修改训练以用于转移性肺癌患者。改编材料将是 由DBT和实施科学领域的专题专家进行审查。据推测，这些活动将 为转移性肺癌患者制定一个手册化的、适应性的DBT技能培训方案（DBT-MLC）。 第二阶段的目标是进行DBT-MLC的试点测试，以评估可行性，可接受性，并检查干预前后 结果。假设参与者将报告主要（心理困扰，即， 抑郁和焦虑）和次要结果测量（疲劳，呼吸困难，疼痛，情绪调节， 不确定性的容忍度，DBT应对技能的使用）。该项目符合国家癌症研究所的优先事项， 癌症生存的研究领域，并涉及创新适应的循证干预， 得不到充分服务的癌症患者积极的发现将迅速为下一步的研究提供信息， 一项比较DBT-MLC与对照条件的2b期随机疗效试验。这项工作有可能 减少转移性肺癌患者的心理困扰并提高临床疗效。有前途 结果可能鼓励未来适应其他疾病类型和生存阶段。

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. Due to their historically poor prognosis, patients with metastatic lung cancer are often excluded from psychosocial intervention protocols. Existing interventions do not address factors that contribute to elevated psychological distress in these patients, including managing high physical symptom burden (fatigue, dyspnea, pain), regulating challenging emotions (shame, guilt, fear), and tolerating uncertainty about the future. Dialectical behavioral therapy (DBT) is a transdiagnostic, 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. DBT skills training has been adapted for a variety of clinical populations and has demonstrated efficacy in reducing psychological distress. To date, DBT skills training has not been evaluated in patients with metastatic lung cancer, who stand to benefit immensely. We anticipate DBT skills training will need to be adapted to increase acceptability and relevance in patients with metastatic lung cancer, including 1) delivery, 2) dose, and 3) materials. 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 NCCN 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. It is hypothesized that these activities will produce a manualized, adapted DBT skills training protocol for metastatic lung cancer patients (DBT-MLC). Phase II aims to pilot test DBT-MLC to assess feasibility, acceptability, and examine pre-to-post intervention outcomes. It is hypothesized that participants will report improvement on primary (psychological distress, i.e., depression and anxiety) and secondary outcome measures (fatigue, dyspnea, pain, emotion regulation, tolerance of uncertainty, DBT coping skill use). This project meets the National Cancer Institute's priority research area of cancer survivorship, and involves innovative adaptation of an evidence-based intervention for an underserved cancer population. Positive findings would rapidly inform the next step of research, conducting a phase 2b randomized efficacy trial comparing DBT-MLC to a control condition. This work has the potential to reduce psychological distress and enhance clinical outcomes in metastatic lung cancer patients. Promising results may encourage future adaptation for other disease types and stages of survivorship.