PDF(Pubmed)
Abstract：
BACKGROUND: Insomnia is a prevalent sleep disorder that negatively impacts daytime functioning and quality of life. Breast cancer patients report higher rates of insomnia and more circadian disruption than other cancer groups. Approximately 50% of patients experience acute insomnia following breast cancer diagnosis, which often persists during cancer treatment and rehabilitation. Sleep Restriction Therapy (SRT) is a clinically effective and tolerable treatment for persistent insomnia in breast cancer survivors. However, SRT has never been tested on patients with early signs of sleep disturbance who are undergoing cancer treatment. The aim of this pilot randomised controlled trial is to explore the feasibility and preliminary effectiveness of nurse delivered SRT for newly diagnosed breast cancer patients with acute insomnia. The trial has been registered on ClinicalTrials.gov (identifier: NCT06294041).
METHODS: The INVEST (INvestigating the Value of Early Sleep Therapy) trial will recruit 50 newly diagnosed breast cancer patients who meet criteria for acute insomnia. Patients will be recruited from breast cancer results clinics within two Scottish health boards (NHS Grampian and NHS Greater Glasgow and Clyde) and will be block randomised (1:1) to receive nurse delivered SRT or Sleep Hygiene Education (SHE). SRT will be delivered over 4 weekly sessions comprising two face-to-face meetings (either in person or online) and two telephone calls, whereas SHE will be administered in booklet form. Outcomes will be collected at baseline, 6 weeks, and 12 weeks post-randomisation. Primary outcomes in this trial relate to the feasibility of SRT for newly diagnosed breast cancer patients with acute insomnia. Specifically, we will explore (i) rates of patient recruitment and retention, (ii) intervention fidelity, (iii) data collection procedures and outcome measure completion, (iv) intervention acceptability. Secondary outcomes will focus on preliminary evaluation of patient responses to SRT, including insomnia severity, rest-activity rhythms, and mental health.
RESULTS: Our dissemination plan comprises publishing trial outcomes in high-impact, peer-reviewed journals and on breast cancer charity websites and other patient resources. The outcomes from this pilot trial will also inform the development of a full-scale, multicentre RCT of SRT for acute insomnia in newly diagnosed breast cancer patients. University of Strathclyde is the sponsor (reference: UEC23/52). Protocol version v1.2 4 October 2023.
CONCLUSIONS: This trial is the first to explore the value of sleep prehabilitation for newly diagnosed breast cancer patients.This will be the first trial to assess the feasibility of delivering SRT during breast cancer treatment, providing valuable insight into its tolerability and preliminary effectiveness.An embedded process evaluation will assess the acceptability of SRT, providing insight into potential optimisation of the intervention and recommendations for enhancing its future scalability and translation within cancer care.Due to the nature of the SRT intervention, nurse therapists and patients cannot be blinded to treatment allocation, increasing the risk of bias.
METHODS: The INVEST (INvestigating the Value of Early Sleep Therapy) trial will recruit 50 newly diagnosed breast cancer patients who meet criteria for acute insomnia. Patients will be recruited from breast cancer results clinics within two Scottish health boards (NHS Grampian and NHS Greater Glasgow and Clyde) and will be block randomised (1:1) to receive nurse delivered SRT or Sleep Hygiene Education (SHE). SRT will be delivered over 4 weekly sessions comprising two face-to-face meetings (either in person or online) and two telephone calls, whereas SHE will be administered in booklet form. Outcomes will be collected at baseline, 6 weeks, and 12 weeks post-randomisation. Primary outcomes in this trial relate to the feasibility of SRT for newly diagnosed breast cancer patients with acute insomnia. Specifically, we will explore (i) rates of patient recruitment and retention, (ii) intervention fidelity, (iii) data collection procedures and outcome measure completion, (iv) intervention acceptability. Secondary outcomes will focus on preliminary evaluation of patient responses to SRT, including insomnia severity, rest-activity rhythms, and mental health.
RESULTS: Our dissemination plan comprises publishing trial outcomes in high-impact, peer-reviewed journals and on breast cancer charity websites and other patient resources. The outcomes from this pilot trial will also inform the development of a full-scale, multicentre RCT of SRT for acute insomnia in newly diagnosed breast cancer patients. University of Strathclyde is the sponsor (reference: UEC23/52). Protocol version v1.2 4 October 2023.
CONCLUSIONS: This trial is the first to explore the value of sleep prehabilitation for newly diagnosed breast cancer patients.This will be the first trial to assess the feasibility of delivering SRT during breast cancer treatment, providing valuable insight into its tolerability and preliminary effectiveness.An embedded process evaluation will assess the acceptability of SRT, providing insight into potential optimisation of the intervention and recommendations for enhancing its future scalability and translation within cancer care.Due to the nature of the SRT intervention, nurse therapists and patients cannot be blinded to treatment allocation, increasing the risk of bias.
摘要：
背景：失眠是一种普遍的睡眠障碍，会对日间功能和生活质量产生负面影响。与其他癌症组相比，乳腺癌患者的失眠发生率更高，昼夜节律紊乱更多。大约50%的患者在乳腺癌诊断后出现急性失眠，在癌症治疗和康复过程中经常持续存在。睡眠限制疗法（SRT）是一种临床有效且可耐受的治疗乳腺癌幸存者持续性失眠的方法。然而,SRT从未在接受癌症治疗的早期睡眠障碍患者中进行过测试。这项试点随机对照试验的目的是探讨护士为新诊断的乳腺癌急性失眠患者提供SRT的可行性和初步有效性。该试验已在ClinicalTrials.gov上注册（标识符：NCT06294041）。
方法：INVEST（研究早期睡眠疗法的价值）试验将招募50名符合急性失眠标准的新诊断乳腺癌患者。患者将从两个苏格兰卫生委员会（NHSGrampian和NHSGreaterGlasgow和Clyde）的乳腺癌结果诊所招募，并将被随机分组（1：1）接受护士提供的SRT或睡眠卫生教育（SHE）。SRT将每周进行4次会议，包括两次面对面会议（亲自或在线）和两次电话通话。而SHE将以小册子形式管理。结果将在基线时收集，6周,随机化后12周。该试验的主要结果与SRT对新诊断的急性失眠乳腺癌患者的可行性有关。具体来说,我们将探讨(I)患者招募和保留率，(ii)干预保真度，(iii)数据收集程序和成果测量完成，（四）干预措施的可接受性。次要结果将侧重于对患者对SRT的反应的初步评估。包括失眠的严重程度，休息-活动节奏，和心理健康。
结果：我们的传播计划包括发布高影响力的试验结果，同行评审的期刊以及乳腺癌慈善网站和其他患者资源。这项试点试验的结果也将为全面开发，新诊断乳腺癌患者急性失眠SRT的多中心RCT。斯特拉斯克莱德大学是赞助商（参考：UEC23/52）。协议版本v1.22023年10月4日。
结论：该试验首次探讨了睡眠前康复对新诊断乳腺癌患者的价值。这将是第一个评估在乳腺癌治疗期间提供SRT可行性的试验，提供对其耐受性和初步有效性的宝贵见解。嵌入式过程评估将评估SRT的可接受性，提供对干预措施的潜在优化的见解和建议，以增强其在癌症护理中的未来可扩展性和翻译。由于SRT干预的性质，护士治疗师和患者不能对治疗分配视而不见，增加偏见的风险。
方法：INVEST（研究早期睡眠疗法的价值）试验将招募50名符合急性失眠标准的新诊断乳腺癌患者。患者将从两个苏格兰卫生委员会（NHSGrampian和NHSGreaterGlasgow和Clyde）的乳腺癌结果诊所招募，并将被随机分组（1：1）接受护士提供的SRT或睡眠卫生教育（SHE）。SRT将每周进行4次会议，包括两次面对面会议（亲自或在线）和两次电话通话。而SHE将以小册子形式管理。结果将在基线时收集，6周,随机化后12周。该试验的主要结果与SRT对新诊断的急性失眠乳腺癌患者的可行性有关。具体来说,我们将探讨(I)患者招募和保留率，(ii)干预保真度，(iii)数据收集程序和成果测量完成，（四）干预措施的可接受性。次要结果将侧重于对患者对SRT的反应的初步评估。包括失眠的严重程度，休息-活动节奏，和心理健康。
结果：我们的传播计划包括发布高影响力的试验结果，同行评审的期刊以及乳腺癌慈善网站和其他患者资源。这项试点试验的结果也将为全面开发，新诊断乳腺癌患者急性失眠SRT的多中心RCT。斯特拉斯克莱德大学是赞助商（参考：UEC23/52）。协议版本v1.22023年10月4日。
结论：该试验首次探讨了睡眠前康复对新诊断乳腺癌患者的价值。这将是第一个评估在乳腺癌治疗期间提供SRT可行性的试验，提供对其耐受性和初步有效性的宝贵见解。嵌入式过程评估将评估SRT的可接受性，提供对干预措施的潜在优化的见解和建议，以增强其在癌症护理中的未来可扩展性和翻译。由于SRT干预的性质，护士治疗师和患者不能对治疗分配视而不见，增加偏见的风险。
