A mixed-methods investigation of the influence of poor sleep on adherence to adjuvant hormonal therapy in breast cancer survivors

睡眠不良对乳腺癌幸存者辅助激素治疗依从性影响的混合方法研究

• 批准号: 2607728
• 金额: --
• 依托单位: University of Strathclyde
• 依托单位国家: 英国
• 项目类别: Studentship
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=studentship-2607728
• 关键词: mixed; methods; investigation; influence; poor

Following breast cancer treatment, women with hormone positive breast cancer are prescribed hormone therapy for 5-10 years to reduce the risk of breast cancer recurrence. However, around 50% of women prescribed hormone therapy do not take to their prescription as instructed. This represents waste of NHS resources, and increases the risks of cancer recurrence. Often, non-adherence to hormone therapy is related to the significant side effects, one of the most common being disturbed sleep. However, there is a lack of research considering the influence of sleep and other specific side effects on adherence to this treatment, as research tends to group all side effects together. This project aims to address this by conducting: i) a survey-based study investigating the impact of sleep and other side effects on adherence, ii) a pilot intervention study to evaluate the effect of improving sleep on adherence to hormone therapy, and the feasibility of this intervention, iii) a qualitative study to explore the experience of this intervention and its acceptability and feasibility. Study 1) Cross-sectional questionnaire- based study exploring the predictive value of poor sleep and other common side effects on non-adherence to hormone therapy in breast cancer survivors. Cross-sectional data will be obtained using self-reported questionnaires. We will explore the relationship between measures of sleep and other side effects and adherence, then explore the extent to which each individual side effect predicts adherence independently. The relationship between self-report measures of sleep and other side effects will be investigated to identify which variables predict adherence.The study will aim to recruit a large, representative sample (Scottish women aged 18 or over, prescribed adjuvant hormone therapy for primary breast cancer). We will aim to recruit around 400 breast cancer survivors currently prescribed HT. Recruitment will involve liaising with organisations such as Beatson Oncology Centre, Maggie's Centre, and Cancer Support Scotland to facilitate meeting this target. Study 2a) Exploration of the acceptability, feasibility and preliminary effectiveness of CBT-I for poor sleep on improving sleep on adherence to hormone therapyWe will explore the feasibility and acceptability and effectiveness of delivering an intervention for sleep in a population of BCS who are self-reported to be non-adherent to hormone therapy. Participants will be randomly allocated on a 2:1 basis to an intervention group (60 participants) or waitlist control group (30 participants). The intervention group will receive 3 weekly one-hour sessions of Cognitive-Behavioural Therapy (CBT). The study will use a mixed-methods, repeated measures design for assessment of the effectiveness of the intervention (on improving both sleep and adherence) (questionnaires used across 3 assessment points), feasibility of delivering this intervention, the experience and acceptability of the intervention.Study 2b) Qualitative exploration of the acceptability and feasibility of implementing an intervention for sleep to improve adherence Qualitative interview methodology will be used to assess the experience of taking part in the sleep intervention, and to determine any areas of refinement that would enhance the materials or their delivery (acceptability and feasibility). We will aim to recruit 40 participants (female, aged 18 years or older, prescribed adjuvant hormone therapy for primary breast cancer), although recruitment may cease before this point if data saturation is reached. Data will be analysed using thematic analysis.

在乳腺癌治疗后，荷尔蒙阳性乳腺癌妇女被开出为期5-10年的激素治疗处方，以降低乳腺癌复发的风险。然而，在接受激素治疗的女性中，约有50%的人没有按照指示服用处方。这是对NHS资源的浪费，并增加了癌症复发的风险。通常，不坚持激素治疗与显著的副作用有关，最常见的副作用之一是睡眠障碍。然而，缺乏考虑睡眠和其他特定副作用对坚持这种治疗的影响的研究，因为研究倾向于将所有副作用归类在一起。本项目旨在通过以下方式解决这一问题：i)一项基于调查的研究，调查睡眠和其他副作用对坚持治疗的影响；ii)一项初步干预研究，以评估改善睡眠对坚持激素治疗的影响，以及这种干预的可行性；iii)一项定性研究，以探索这种干预的经验及其可接受性和可行性。研究1)基于横断面问卷的研究，探讨睡眠不良和其他常见副作用对乳腺癌幸存者不坚持激素治疗的预测价值。横断面数据将使用自填式问卷获得。我们将探索睡眠和其他副作用与依从性之间的关系，然后探索每个个体副作用独立预测依从性的程度。将调查睡眠自我报告措施和其他副作用之间的关系，以确定哪些变量预测坚持。这项研究的目标是招募具有代表性的大样本(18岁或以上的苏格兰妇女，针对原发性乳腺癌的处方辅助激素治疗)。我们的目标是招募大约400名目前服用羟色胺的乳腺癌幸存者。招募将包括与比森肿瘤学中心、玛吉中心和苏格兰癌症支持中心等组织联系，以促进实现这一目标。研究2a)探讨CBT-I在改善坚持激素治疗的睡眠方面的可接受性、可行性和初步有效性我们将探索对自我报告不坚持激素治疗的BCS人群进行睡眠干预的可行性、可接受性和有效性。参与者将按2：1的比例随机分配到干预组(60名参与者)或等待名单对照组(30名参与者)。干预组将接受每周三次为期一小时的认知-行为疗法(CBT)。研究将使用混合方法、重复测量设计来评估干预的有效性(关于改善睡眠和依从性)(在三个评估点使用的问卷)、实施该干预的可行性、干预的经验和可接受性。研究2b)定性探索实施睡眠干预以提高依从性的可接受性和可行性将使用定性访谈方法来评估参与睡眠干预的经验，并确定任何可提高材料或其提供的改进领域(可接受性和可行性)。我们的目标是招募40名参与者(女性，18岁或以上，对原发性乳腺癌进行处方辅助激素治疗)，尽管如果数据达到饱和，招募可能会在这一点之前停止。将使用专题分析对数据进行分析。