CBT +/- Modafinil for Insomnia and Fatigue following Chemotherapy

描述(申请人提供)：睡眠障碍，特别是失眠，在癌症幸存者中比普通人群中更普遍。据认为，在抗癌治疗后，40%至65%的患者会发生失眠。除了无处不在的失眠，失眠还与疲劳和生活质量(QOL)下降密切相关，被认为是导致这两种疾病的重要因素。到目前为止，很少有研究确定在普通人群中用于治疗失眠的既定方法，例如认知行为疗法(CBT-I)是否也有效地治疗癌症引起的失眠和/或其治疗。对于癌症幸存者的这一问题，也需要新的治疗策略，特别是解决这一患者群体中出现的持续性疲劳的策略。莫达非尼是此类研究的首选候选药物。来自我们小组的初步数据显示，莫达非尼减少了乳腺癌患者治疗后的睡眠问题和疲倦。我们还完成了一项研究，显示莫达非尼提高了原发性失眠患者对CBT-I的治疗依从性。这两项初步研究，再加上最近发表的CBT-I在乳腺癌幸存者中非常成功的随机对照试验，表明CBT-I和莫达非尼在治疗癌症幸存者失眠方面都发挥了作用。因此，我们建议联合治疗将对癌症患者特别有效，因为联合治疗将允许治疗癌症幸存者经常相互关联的失眠和疲劳症状。方法：226名患有慢性失眠的乳腺癌幸存者将被招募，并被随机分配到四种治疗方案中的一种(CBT-I、莫达非尼、两者都用，或者都不用)。这项为期七周的干预旨在确定这些治疗策略在减少癌症幸存者的失眠和疲劳以及改善生活质量方面的有效性和可接受性。在研究干预前、干预后两周、干预后三个月分别以日记和问卷的形式进行评估。此外，将对226名患者中的100名进行干预前和干预后的多导睡眠图评估，以确定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.