Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada; Discipline of Oncology, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada; Beatrice Hunter Cancer Research Institute, Halifax, Nova Scotia, Canada.
École de psychologie, Université Laval and CHU de Québec-Université Laval Research Center, Quebec, Canada.
Contemp Clin Trials. 2021 Apr;103:106322. doi: 10.1016/j.cct.2021.106322. Epub 2021 Feb 12.
Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning. Cognitive-behaviour therapy for insomnia (CBT-I) is the treatment of choice for insomnia among cancer survivors. Literature suggests that treatment with CBT-I may lead to an improvement in PCI, but this needs to be tested in a sample of patients with PCI at study entry with cognitive impairments as the primary study outcome. Here we describe the design of a clinical trial to evaluate the efficacy of videoconference-delivered CBT-I for the improvement of PCI among cancer survivors. This project is a randomized waitlist-controlled trial with a recruitment target of 124 adult cancer survivors (solid tumors and hematological malignancies) who have completed primary treatment at least 6 months prior, report PCI and meet criteria for insomnia disorder. Participants will complete assessments at baseline, 4 weeks (mid-treatment), 8 weeks (post treatment), and 3 and 6 months post-treatment. The primary outcome is the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog). Treatment of PCI in cancer patients is a priority for clinicians, researchers, and patients. This research will increase our understanding of the mechanisms of cognitive impairment associated with cancer, and potentially expand currently available treatment options.
感知认知障碍（PCI）和睡眠障碍（如失眠）是常见的阻碍癌症幸存者恢复正常功能的因素。认知行为疗法治疗失眠（CBT-I）是癌症幸存者失眠的首选治疗方法。文献表明，CBT-I 治疗可能会改善 PCI，但这需要在以认知障碍为主要研究结果的 PCI 患者样本中进行测试。在这里，我们描述了一项临床试验的设计，该试验旨在评估视频会议提供的 CBT-I 对改善癌症幸存者 PCI 的疗效。该项目是一项随机等待对照试验，目标招募 124 名成年癌症幸存者（实体瘤和血液恶性肿瘤），他们在至少 6 个月前完成了主要治疗，报告 PCI 并符合失眠障碍标准。参与者将在基线、4 周（治疗中期）、8 周（治疗后）以及治疗后 3 个月和 6 个月进行评估。主要结局是癌症治疗认知功能量表（FACT-Cog）。治疗癌症患者的 PCI 是临床医生、研究人员和患者的优先事项。这项研究将增加我们对与癌症相关的认知障碍机制的理解，并可能扩大目前可用的治疗选择。
