Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients

转移性肺癌患者辩证行为治疗技能培训

• 批准号: 10314204
• 负责人: Kelly Alexandra Hyland
• 金额: $ 6.56万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10314204
• 关键词: Address; Anxiety; Area; Behavior Therapy; Behavioral; Behavioral Symptoms; Cancer Patient; Cancer Survivorship; Chronic Disease; Clinical; Coping Skills; Disease; Distress; Dose; Dyspnea; Effectiveness; Elements; Emotions; Environmental Risk Factor; Evidence based intervention; Fatigue; Feedback; Focus Groups; Fright; Future; Goals; Group Interviews; Guilt; Health; Health Benefit; Hour; Immunocompromised Host; Intervention; Interview; Length; Link; Malignant Neoplasms; Malignant neoplasm of lung; Mental Depression; National Cancer Institute; National Comprehensive Cancer Network; Outcome; Outcome Measure; Pain; Participant; Patient Education; Patients; Persons; Phase; Population; Production; Prognosis; Prognostic Marker; Protocols documentation; Provider; Psychological Impact; Psychotherapy; Public Health; Quality of life; Randomized; Reporting; Research; Research Priority; Science; Shame; Symptoms; Target Populations; Testing; Thermometers; Thoracic Oncology; Time; Uncertainty; Visit; Work; anticancer research; base; behavior change; cancer therapy; cancer type; cost; distress tolerance; efficacy trial; emotion regulation; emotional symptom; evidence base; experience; implementation science; improved; innovation; mindfulness; novel; patient population; physical symptom; post intervention; primary outcome; psychological distress; psychological symptom; psychosocial; satisfaction; secondary outcome; skills; skills training; survivorship; symptom management; trial comparing

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.

转移性肺癌患者经历显着更大的心理困扰（即抑郁、 焦虑）与其他癌症相比。心理困扰是临床状况恶化的一个预后指标 癌症患者的结果和较差的总体生存率。由于历史上预后不良，患有此类疾病的患者 转移性肺癌通常被排除在心理社会干预方案之外。现有的干预措施确实 没有解决导致这些患者心理困扰加剧的因素，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）、 并容忍未来的不确定性。辩证行为疗法（DBT）是一种跨诊断、循证的治疗方法。 基于心理治疗，教导参与者一套核心行为技能（痛苦耐受力、情绪 调节、正念、人际关系有效性）以更有效地应对情绪和身体问题 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 技能培训尚未在患有以下疾病的患者中进行评估： 转移性肺癌，他们将受益匪浅。我们预计 DBT 技能培训需要 旨在提高转移性​​肺癌患者的可接受性和相关性，包括 1) 分娩， 2) 剂量，以及 3) 材料。拟议的研究旨在调整和试点测试针对患有以下疾病的患者的 DBT 技能培训： 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 遇险温度计得分 >3 的人。第一阶段旨在利用焦点小组和关键人物访谈 利益相关者（转移性肺癌患者 (N=20)、胸部肿瘤科提供者 (N=6)、临床医生 生存和行为症状管理 (N=6)) 方面的专业知识，以确定是否以及如何使用 DBT 技能 必须修改培训以适应转移性肺癌患者。改编的材料将是 由 DBT 和实施科学领域的主题专家进行审查。假设这些活动将 为转移性肺癌患者制定手动、适应性的 DBT 技能培训方案 (DBT-MLC)。 第二阶段旨在试点 DBT-MLC，以评估可行性、可接受性并检查前后干预 结果。假设参与者将报告主要问题（心理困扰，即 抑郁和焦虑）和次要结果指标（疲劳、呼吸困难、疼痛、情绪调节、 对不确定性的容忍度、DBT 应对技巧的使用）。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，并涉及基于证据的干预措施的创新适应 得不到充分服务的癌症人群。积极的发现将迅速为下一步研究提供信息，进行 将 DBT-MLC 与对照条件进行比较的 2b 期随机疗效试验。这项工作有潜力 减少转移性肺癌患者的心理困扰并提高临床结果。有前途 结果可能会鼓励未来适应其他疾病类型和生存阶段。