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

描述（由申请人提供）：与其他癌症幸存者相比，肺癌幸存者患睡眠障碍的风险特别高。据估计，肺癌幸存者中失眠症的患病率超过50%，最高可达80%，失眠症在诊断后平均持续8年。吸烟史、既往慢性阻塞性肺疾病（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。迄今为止，关于有效减少肺癌幸存者失眠的策略的研究很少，特别是护士在床边应用认知行为疗法治疗失眠（CBT-I）。失眠的认知行为疗法（CBT-I）在临床上可以显著改善失眠症状，而没有催眠药物通常报道的负面影响。虽然CBT-I是许多疾病中公认的有效治疗失眠的方法，但仍迫切需要研究肺癌幸存者的CBT-I，因为他们与其他癌症患者不同，因为他们以前或现在有吸烟史，存在慢性阻塞性肺病，肺容量下降。CBT-I治疗合并症失眠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治疗，重点关注与睡眠有关的功能失调想法和可能加剧失眠的无益睡眠行为。本研究提出了一种多层次的转化方法来解决肺癌幸存者的特定需求。目的1将确定标准CBT-I治疗方案对肺癌幸存者的疗效。本研究的目的2提出，通过对实施的形成性评估，将肺癌患者的CBT-I转化为护理实践，重点关注(a)患者和患者-提供者促进者的特征，以及(b)工作人员护士的知识和技能。翻译是将这种干预措施纳入标准护理的重要步骤。140名肺癌幸存者将被随机分配到CBT-I或注意力控制组。在干预前和干预后5周评估患者的睡眠、情绪、功能状态和生活质量。主要结果将是自我报告的睡眠效率（睡眠时间/卧床时间；>85%=良好睡眠）。这项研究将首次证明一种有效的、众所周知的干预措施对肺癌人群的应用和适应性，并为更大规模的研究提供信息，以评估将促进这种干预措施的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，改善无数因失眠而遭受严重影响的肺癌患者的生活质量，这些患者目前没有任何针对他们和他们的疾病的治疗方法。因此，快速转化为临床应用使得这在临床方面很有吸引力，但在个体患者层面也有很大的希望。

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.