CBT +/- Modafinil for Insomnia and Fatigue following Chemotherapy

CBT /- 莫达非尼治疗化疗后失眠和疲劳

• 批准号: 7761310
• 负责人: JOSEPH A ROSCOE
• 金额: $ 49.33万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-02-01 至 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7761310
• 关键词: Address; Adverse effects; Affect; Aftercare; Agonist; Antidepressive Agents; Anxiety; Beds; Benzodiazepine Receptor; Benzodiazepines; Cancer Center; Cancer Patient; Cancer Survivor; Chronic Insomnia; Clinical; Cognitive Therapy; Combined Modality Therapy; Community Clinical Oncology Program; Coupled; Data; Diagnosis; Enrollment; Equation; Exclusion Criteria; Fatigue; Female Breast Carcinoma; General Population; Health; Intervention; Intervention Studies; Link; Maintenance; Malignant Neoplasms; Measures; Mediating; Mental Depression; Methods; Minority; Modafinil; Modeling; Needs Assessment; Outcome; Pain; Participant; Patients; Placebos; Polysomnography; Population; Primary Insomnia; Principal Investigator; Protocols documentation; Published Comment; Publishing; Quality of life; Questionnaires; Radiation therapy; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Regimen; Regression Analysis; Reporting; Research; Research Design; Research Personnel; Role; Sample Size; Sampling; Screening procedure; Selection Bias; Seminal; Severities; Sleep; Sleep Apnea Syndromes; Sleep Architecture; Sleep Disorders; Sleep disturbances; Sleeplessness; Study Section; Study Subject; Subgroup; Surveys; Symptoms; Temazepam; Testing; Therapeutic; Time; Trazodone; Treatment Efficacy; Universities; Work; acronyms; arm; cancer diagnosis; cancer therapy; chemotherapy; compliance behavior; design; diaries; experience; falls; hypnotic; improved; indexing; intervention effect; malignant breast neoplasm; novel strategies; post intervention; programs; prospective; randomized trial; treatment strategy; zolpidem

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.

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为普遍。据认为，40% 至 65% 的患者在接受抗癌治疗后会出现失眠。除了普遍存在之外，失眠还与疲劳和生活质量下降密切相关，并且被认为是造成这两者的重要因素。迄今为止，很少有研究来确定用于治疗普通人群失眠的既定方法（例如失眠认知行为疗法（CBT-I））是否也能有效治疗癌症和/或癌症引起的失眠。它的治疗。针对癌症幸存者的这一问题还需要新的治疗策略，特别是解决该患者群体中出现的持续疲劳的策略。此类研究的主要候选者是莫达非尼。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，表明莫达非尼可以提高原发性失眠患者对 CBT-I 的治疗依从性。这两项初步研究，加上最近发表的一项非常成功的、针对乳腺癌幸存者的 CBT-I 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有作用。因此，我们建议联合疗法对癌症患者特别有效，因为联合方法将能够控制癌症幸存者的失眠和疲劳等经常相互关联的症状。方法：将招募 226 名患有慢性失眠的乳腺癌幸存者，并随机接受四种治疗条件之一（CBT-I、莫达非尼、两者或两者都不是）。为期七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、之后两周和三个月后通过日记和问卷进行评估。此外，还将对 226 名患者中的 100 名患者进行干预前和干预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。