Women with breast cancer experience a significantly higher prevalence of sleep disturbance and insomnia than the general population. The experience of persistent sleep disturbance places these women at a higher risk of psychological and physical morbidity and a reduced quality of life. Treatment for sleep in this population is not part of routine care and is often managed inadequately. This randomised controlled trial will examine the combined effects of cognitive behavioural therapy (CBT) and bright light therapy (BLT) on the symptoms of insomnia, fatigue and mental health. Women diagnosed with breast cancer who receive intravenous chemotherapy treatment at a quaternary referral metropolitan cancer centre in Melbourne, Australia, will be recruited. Recruitment will occur after diagnosis and prior to completion of chemotherapy. Eligible women will be randomised to the combined CBT and BLT intervention (CBT+) or relaxation audio-enhanced treatment as usual (TAU+). The CBT+ group will receive one face-to-face session on sleep strategies, one subsequent telephone call, and seven email packages containing CBT-based information and strategies. CBT+ participants will also wear Luminette® light glasses for 20 min each morning for the 6-week duration of the intervention. Women in TAU+ will receive two relaxation audio tracks via email. Outcomes will be measured at multiple points throughout the 6 weeks. Primary outcomes will be symptoms of insomnia and sleep efficiency, measured using the Insomnia Severity Index and a self-reported sleep diary. Secondary outcomes include objective measures of sleep assessed using the ActiGraph wGT3X-BT, and sleep-related complaints, fatigue and mental health, all assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). Data will also be collected on potential treatment moderators and mechanisms and adherence to treatment. There will be 3-month follow-up measurements of insomnia symptoms, fatigue, sleep-related impairment, sleep disturbance, depression and anxiety. This is the first randomised controlled trial to combine CBT and BLT for the treatment of sleep disturbance in women with breast cancer. This novel design addresses the multiple causal factors for sleep complaints in this population. Results from this trial will advance knowledge in this field and may have important clinical implications for how best to treat sleep disturbance and insomnia in this population. If effective, the largely email-based format of the intervention would allow for relatively easy translation. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12618001255279. Retrospectively registered on 25 July 2018.

中文翻译：

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睡眠和疲劳的光增强认知行为疗法：乳腺癌化疗期间随机对照试验的研究方案

乳腺癌妇女的睡眠障碍和失眠患病率明显高于普通人群。持续性睡眠障碍的经历使这些妇女处于较高的心理和身体疾病风险中，并降低了生活质量。在这个人群中进行睡眠治疗不是常规护理的一部分，并且通常管理不当。这项随机对照试验将研究认知行为疗法（CBT）和强光疗法（BLT）对失眠，疲劳和心理健康症状的综合作用。将招募在澳大利亚墨尔本的四级转诊大都会癌症中心接受静脉化疗的诊断为乳腺癌的妇女。招募将在诊断后和化疗完成之前进行。符合条件的妇女将被随机分配到CBT和BLT联合干预（CBT +）或照常进行放松音频增强治疗（TAU +）。CBT +小组将接受一次有关睡眠策略的面对面会议，接听一个电话，以及七个包含基于CBT的信息和策略的电子邮件软件包。在为期6周的干预期间，CBT +参与者还将每天早上佩戴Luminette®光学眼镜20分钟。TAU +中的女性将通过电子邮件收到两条放松的音轨。在整个6周内，将在多个时间点评估结局。主要结果是失眠症状和睡眠效率，可使用失眠严重度指数和自我报告的睡眠日记来衡量。次要结果包括使用ActiGraph wGT3X-BT评估的客观睡眠指标，以及与睡眠相关的抱怨，疲劳和心理健康，所有这些都使用患者报告的结果测量信息系统（PROMIS）进行评估。还将收集有关潜在治疗调节剂和机制以及对治疗依从性的数据。将对失眠症状，疲劳，与睡眠有关的障碍，睡眠障碍，抑郁和焦虑进行3个月的随访测量。这是第一项将CBT和BLT联合用于治疗乳腺癌女性睡眠障碍的随机对照试验。这种新颖的设计解决了该人群中睡眠不佳的多种原因。该试验的结果将提高该领域的知识，并且可能对如何最好地治疗该人群的睡眠障碍和失眠具有重要的临床意义。如果有效，干预措施主要是基于电子邮件的格式，因此翻译相对容易。澳大利亚新西兰临床试验注册中心（ANZCTR），ACTRN12618001255279。追溯注册于2018年7月25日。