School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 18 Innovation Walk, Melbourne, VIC 3800, Australia.
Memorial University, Newfoundland and Labrador, Canada.
Contemp Clin Trials. 2022 Sep;120:106877. doi: 10.1016/j.cct.2022.106877. Epub 2022 Aug 10.
BACKGROUND: Insomnia and fatigue symptoms are common in breast cancer. Active cancer treatment, such as chemotherapy, appears to be particularly disruptive to sleep. Yet, sleep complaints often go unrecognised and under treated within routine cancer care. The abbreviated delivery of cognitive behavioral therapy for Insomnia (CBTI) and bright light therapy (BLT) may offer accessible and cost-effective sleep treatments in women receiving chemotherapy for breast cancer. METHODS: The Sleep, Cancer and Rest (SleepCaRe) Trial is a 6-month multicentre, randomized, controlled, 2 × 2 factorial, superiority, parallel group trial. Women receiving cytotoxic chemotherapy for breast cancer at tertiary Australian hospitals will be randomly assigned 1:1:1:1 to one of four, non-pharmacological sleep interventions: (a) Sleep Hygiene and Education (SHE); (b) CBTI; (c) BLT; (d) CBT-I + BLT combined and simultaneously delivered. Each sleep intervention is delivered over 6 weeks, and will comprise an introductory session, a mid-point phone call, and regular emails. The primary (insomnia, fatigue) and secondary (health-related quality of life, rest activity rhythms, sleep-related impairment) outcomes will be assessed via online questionnaires at five time-points: baseline (t0, prior to intervention), mid-point intervention (t2, Week 4), post-intervention (t3, Week 7), 3-months (t4, Week 18), and 6-months follow-up (t5, Week 30). CONCLUSIONS: This study will report novel data concerning the comparative and combined efficacy of CBT-I and BLT during chemotherapy. Findings will contribute to the development of evidence-based early sleep and fatigue intervention during chemotherapy for breast cancer. Clinical trial information Registered with the Australian New Zealand Clinical Trials Registry (http://anzctr.org.au/), Registration Number: ACTRN12620001133921.
背景:失眠和疲劳症状在乳腺癌患者中很常见。积极的癌症治疗,如化疗,似乎对睡眠有特别大的影响。然而,在常规癌症护理中,睡眠问题往往未被识别和治疗。简短的失眠认知行为疗法(CBTI)和亮光疗法(BLT)的应用为接受乳腺癌化疗的女性提供了易于获取且具有成本效益的睡眠治疗方法。
方法:睡眠、癌症和休息(SleepCaRe)试验是一项为期 6 个月的多中心、随机、对照、2×2 因子、优效性、平行组试验。在澳大利亚三级医院接受细胞毒性化疗治疗乳腺癌的女性将被随机分为 1:1:1:1 四组,接受以下四种非药物睡眠干预措施之一:(a)睡眠卫生和教育(SHE);(b)CBTI;(c)BLT;(d)CBT-I + BLT 联合并同时进行。每种睡眠干预措施持续 6 周,包括介绍性会议、中点电话随访和定期电子邮件。主要(失眠、疲劳)和次要(健康相关生活质量、休息活动节律、睡眠相关障碍)结局将通过在线问卷调查在五个时间点进行评估:基线(t0,干预前)、中点干预(t2,第 4 周)、干预后(t3,第 7 周)、3 个月(t4,第 18 周)和 6 个月随访(t5,第 30 周)。
结论:本研究将报告关于 CBT-I 和 BLT 在化疗期间比较和联合疗效的新数据。研究结果将为乳腺癌化疗期间早期睡眠和疲劳干预的循证方法的制定提供依据。临床试验信息 澳大利亚和新西兰临床试验注册中心(http://anzctr.org.au/)注册,注册号:ACTRN12620001133921。
Front Neurol. 2023-6-15
Contemp Clin Trials Commun. 2023-1-31