CBT +/- Modafinil for Insomnia and Fatigue following Chemotherapy

描述（由申请人提供）：睡眠障碍，特别是失眠，在癌症幸存者中比在一般人群中更普遍。据认为，在抗癌治疗后，40%至65%的患者会出现免疫缺陷。除了其普遍性之外，失眠与疲劳和生活质量（QOL）降低密切相关，并且被认为是两者的重要促成因素。迄今为止，很少有研究确定用于治疗一般人群失眠的既定方法，例如，失眠症的认知行为疗法（CBT-I）也有效治疗癌症和/或其治疗引起的失眠症。针对癌症幸存者的这一问题，也需要新的治疗策略，特别是那些解决这一患者群体中出现的持续疲劳的策略。莫达非尼是此类研究的主要候选者。我们小组的初步数据显示，莫达非尼可以减少乳腺癌患者治疗后的睡眠问题和疲劳。我们还完成了一项研究，显示莫达非尼提高原发性失眠患者对CBT-I治疗的依从性。这两项初步研究，加上最近发表的一项非常成功的，随机对照的乳腺癌幸存者CBT-I试验，表明CBT-I和莫达非尼在治疗癌症幸存者失眠方面的作用。因此，我们建议联合治疗在癌症患者中特别有效，因为联合方法将允许管理癌症幸存者中经常相互关联的失眠和疲劳症状。研究方法：将招募226名患有慢性失眠症的乳腺癌幸存者，并随机分配至四种治疗条件之一（CBT-I、莫达非尼、两者或两者都不）。为期7周的干预旨在确定这些治疗策略在减少失眠和疲劳以及改善癌症幸存者生活质量方面的有效性和可接受性。将在研究干预之前、期间、之后2周和之后3个月通过日记和问卷进行评估。此外，将对226名患者中的100名进行干预前后的多导睡眠图评估，以表征这些干预措施对睡眠结构的影响。

DESCRIPTION (provided by applicant): Sleep disturbance, particularly insomnia, is far more prevalent in cancer survivors than in the general population. Insomnia is thought to occur in 40 percent to 65 percent of patients following anti-cancer treatment. Apart from its ubiquity, insomnia is strongly associated with fatigue and reduced quality of life (QOL) and is thought to be an important contributing factor to both. To date, very few studies have been conducted to determine if established methods used to treat insomnia in the general population, e.g., cognitive behavioral therapy for insomnia (CBT-I), are also effective in treating the insomnia that occurs with cancer and/or its treatment. New treatment strategies for this problem in cancer survivors are also needed, particularly ones that address the persistent fatigue that occurs in this patient group. A prime candidate for such research is modafinil. Preliminary data from our group show that modafinil reduces sleep problems and fatigue in breast cancer patients post treatment. We have also completed a study showing that modafinil enhances treatment compliance with CBT-I in patients with primary insomnia. These two initial studies, coupled with a recently published, very successful, randomized, controlled trial of CBT-I in breast cancer survivors, suggest a role for both CBT-I and modafinil in treating insomnia in cancer survivors. Accordingly, we propose that the combination of therapies will be particularly efficacious in cancer patients because the combined approach will allow for the management of the often interrelated symptoms of insomnia and fatigue in cancer survivors. Methods: 226 Breast cancer survivors with chronic insomnia will be recruited and randomized to one of four treatment conditions (CBT-I, modafinil, both, or neither). The seven-week intervention is designed to determine the efficacy and acceptability of these treatment strategies in reducing insomnia and fatigue and in improving QOL in cancer survivors. Assessments will be made by diary and by questionnaires before, during, two weeks following, and three months following the study intervention. In addition, pre- and post-intervention polysomnographic assessments will be conducted in 100 of the 226 patients in order to characterize the effects of these interventions on sleep architecture.