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

在乳腺癌治疗之后，患有激素阳性乳腺癌的妇女需要接受5-10年的激素治疗，以降低乳腺癌复发的风险。然而，大约50%的接受激素治疗的女性没有按照指示服用处方。这代表了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受到干扰。然而，由于研究倾向于将所有副作用归为一类，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。本项目旨在通过以下方式解决这个问题：i)一项基于调查的研究，调查睡眠和其他副作用对依从性的影响；ii)一项试点干预研究，评估改善睡眠对激素治疗依从性的影响，以及这种干预的可行性；iii)一项定性研究，探索这种干预的经验及其可接受性和可行性。研究1)基于横断面问卷调查的研究，探讨乳腺癌幸存者不坚持激素治疗的睡眠质量差和其他常见副作用的预测价值。横断面数据将通过自我报告问卷获得。我们将探索睡眠测量与其他副作用和依从性之间的关系，然后探索每个副作用独立预测依从性的程度。研究人员将调查睡眠自我报告与其他副作用之间的关系，以确定哪些变量可以预测依从性。这项研究的目标是招募一个大的、有代表性的样本（18岁或以上的苏格兰女性，接受原发性乳腺癌的辅助激素治疗）。我们的目标是招募大约400名乳腺癌幸存者，他们目前正在接受治疗。招聘将涉及与比特森肿瘤中心、麦琪中心和苏格兰癌症支持中心等组织联络，以促进实现这一目标。研究2a)探索CBT-I治疗不良睡眠对激素治疗依从性改善睡眠的可接受性、可行性和初步有效性我们将探索在自我报告不坚持激素治疗的BCS人群中提供睡眠干预的可行性、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人）或等候名单对照组（30人）。干预组每周接受3次一小时的认知行为治疗（CBT）。该研究将使用混合方法，重复测量设计来评估干预的有效性（改善睡眠和依从性）（在3个评估点上使用问卷），提供这种干预的可行性，干预的经验和可接受性。研究2b)实施睡眠干预以提高依从性的可接受性和可行性的定性探索定性访谈方法将用于评估参与睡眠干预的经验，并确定任何改进的领域，以增强材料或其交付（可接受性和可行性）。我们的目标是招募40名参与者（女性，年龄在18岁或以上，对原发性乳腺癌进行辅助激素治疗），尽管如果达到数据饱和，招募可能会在此之前停止。数据将采用专题分析进行分析。

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.