Translating CBT-Insomnia for Lung Cancer into practice: A RCT

描述（由申请人提供）：相对于其他癌症幸存者，肺癌幸存者发生睡眠障碍的风险特别高。肺癌幸存者中失眠的患病率估计超过50%，高达80%，失眠在诊断后平均持续8年。吸烟史、既存慢性阻塞性肺疾病（COPD）和肺癌治疗的影响，特别是部分肺切除术和术后放疗可导致肺功能受损，导致疼痛、咳嗽和呼吸困难引起的过度觉醒，从而导致失眠恶化。到目前为止，很少有研究存在的策略，以有效地减少肺癌幸存者失眠，特别是在应用认知行为治疗失眠（CBT-I）在床边的护士。失眠症的认知行为疗法（CBT-I）导致失眠症状的临床显着改善，而没有催眠药物通常报告的负面影响。虽然CBT-I是治疗许多疾病失眠的一种行之有效的治疗方法，但仍然迫切需要在肺癌幸存者中研究CBT-I，因为他们与其他癌症患者不同，因为他们以前或目前有吸烟史，存在COPD，以及肺活量减少。CBT-I治疗共病失眠症的适当剂量和频率尚未确定。CBT-I包括睡眠限制，刺激控制，放松，睡眠卫生教育和认知疗法，重点是与睡眠有关的不良想法和可能加剧失眠的无益睡眠行为。这项研究提出了一种多层次的，转化的方法来解决肺癌幸存者的特定需求。目标1将确定标准CBT-I治疗方案在肺癌幸存者中的疗效。目的2的研究提出了翻译CBT-I肺癌患者的护理实践中执行的形成性评价的实施集中在（a）表征的病人和病人提供者的促进者和（B）护士的知识和技能。翻译是将这种干预嵌入标准护理的重要步骤。140名肺癌幸存者将被随机分配至CBT-I组或注意力控制组。在干预前和干预后5周，将对睡眠、情绪、功能状态和生活质量进行评估。主要结果将是自我报告的睡眠效率（睡眠时间/床上时间; >85%=良好睡眠）。这项研究将首次展示一种有效的、众所周知的干预措施在肺癌人群中的应用和适应性，并为一项更大规模的研究提供信息，以评估促进这种干预措施传播和可持续性的实施策略。最终目标是提供实用的，适应性强的和可实施的干预措施，改善无数肺癌患者的生活质量，这些患者遭受失眠的深刻影响，而目前没有任何针对他们及其疾病的治疗方法。因此，快速转化为临床应用使其在临床前沿具有吸引力，但在个体患者水平上也具有重要的前景。

DESCRIPTION (provided by applicant): Lung cancer survivors have a particularly high risk of developing sleep disorders relative to other cancer survivors. Prevalence estimates for insomnia in lung cancer survivors is over 50% and as high as 80% and insomnia persists an average of eight years after diagnosis. Smoking history, pre-existing chronic obstructive pulmonary disease (COPD), and the effects of lung cancer treatment, in particular, partial lung resection and postoperative radiotherapy can result in impaired pulmonary function resulting in hyperarousal from pain, cough and dyspnea leading to a worsening of insomnia. To date, little research exists on strategies to effectively reduce insomnia in lung cancer survivors, especially in the application of cognitive behavioral therapy for insomnia (CBT-I) at the bedside by nurses. Cognitive behavior therapy for insomnia (CBT-I) results in clinically significant improvements in insomnia symptoms without the negative effects commonly reported with hypnotic medications. While CBT-I is a well-established and effective treatment for insomnia in many diseases, there remains a pressing need to study CBT-I in lung cancer survivors because they are different from other cancer patients due to their previous or current tobacco smoking history, presence of COPD, and diminished pulmonary capacity. The appropriate dose and frequency of CBT-I in comorbid insomnia has not been determined. CBT-I consists of sleep restriction, stimulus control, relaxation, sleep hygiene education and cognitive therapy that focuses on dysfunctional sleep-related thoughts and unhelpful sleep behaviors that may exacerbate insomnia. This study proposes a multi-tiered, translational approach to address specific needs of lung cancer survivors. Aim 1 will determine the efficacy of a standard CBT-I treatment protocol in lung cancer survivors. Aim 2 of the study proposes to translate CBT-I for patients with lung cancer into nursing practice by performing a formative evaluation of the implementation focused on (a) characterization of the patient and patient-provider facilitators and (b) knowledge and skills among staff nurses. Translation is an important step for embedding this intervention into standard nursing care. One hundred forty lung cancer survivors will be randomized to either CBT-I or attention control. Sleep, mood, functional status and quality of life will be evaluated before and 5-weeks after the intervention. The primary outcome will be self-reported sleep efficiency (time asleep/time in bed; >85%=good sleep). This study will demonstrate the application and adaptability of an effective, well-known intervention to the lung cancer population for the first time and inform a larger study to evaluate implementation strategies that will promote the dissemination and sustainability of this intervention. The ultimate goal is to offr practical, adaptable and implementable interventions that improve the quality of life for the countless lung cancer patients who suffer profound effects of insomnia without any currently-available treatment modified for them and their disease. Thus, the rapid translation to clinical application makes this appealing on the clinical front but has significant promise at the individua patient level as well.