School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 18 Innovation Walk, Melbourne, VIC, 3800, Australia.
Centre for Women's Mental Health, Royal Women's Hospital, Melbourne, Australia.
Trials. 2020 Mar 27;21(1):295. doi: 10.1186/s13063-020-4196-4.
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.
METHOD/DESIGN: 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.
患有乳腺癌的女性比一般人群经历更高的睡眠障碍和失眠发生率。持续的睡眠障碍使这些女性面临更高的心理和生理发病率以及生活质量降低的风险。该人群的睡眠治疗不是常规护理的一部分，并且通常管理不足。这项随机对照试验将研究认知行为疗法（CBT）和明亮光疗法（BLT）对失眠、疲劳和心理健康症状的联合影响。
方法/设计：将招募在澳大利亚墨尔本的一家四等转诊大都市癌症中心接受静脉内化疗治疗的乳腺癌诊断女性。招募将在诊断后且在完成化疗前进行。符合条件的女性将被随机分配到联合 CBT 和 BLT 干预组（CBT+）或放松音频增强治疗作为常规护理组（TAU+）。CBT+组将接受一次关于睡眠策略的面对面会议、一次后续电话以及包含基于 CBT 的信息和策略的七个电子邮件包。CBT+参与者还将在干预的 6 周内每天早晨佩戴 Luminette®光眼镜 20 分钟。TAU+中的女性将通过电子邮件收到两个放松音频曲目。在整个 6 周期间将在多个时间点测量结果。主要结局指标是使用失眠严重程度指数和自我报告的睡眠日记测量的失眠症状和睡眠效率。次要结局指标包括使用 ActiGraph wGT3X-BT 评估的客观睡眠测量值，以及使用患者报告的结果测量信息系统（PROMIS）评估的睡眠相关抱怨、疲劳和心理健康。还将收集潜在治疗调节剂和机制以及治疗依从性的数据。将对失眠症状、疲劳、睡眠相关损害、睡眠障碍、抑郁和焦虑进行 3 个月的随访测量。
这是第一项联合 CBT 和 BLT 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睡眠抱怨的多个因果因素。该试验的结果将推进该领域的知识，并可能对如何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，干预措施的主要基于电子邮件的格式将允许相对容易地进行翻译。
澳大利亚和新西兰临床试验注册中心（ANZCTR），ACTRN12618001255279。于 2018 年 7 月 25 日回顾性注册。
