Ecological Momentary Assessment of Quality of Life in Metastatic Breast Cancer

项目摘要 尽管乳腺癌预防和治疗取得了进展，但仍有成千上万的人被新诊断为乳腺癌。 转移性乳腺癌（MBC）。MBC可导致生活质量显著下降 (QoL)这是一个多层面的概念，包括身体和情感的健康。鉴于无法治愈的性质， MBC、QoL是一项关键结局。此外，来自我们小组和其他人的数据表明， MBC患者的QoL相关需求未得到满足，并希望获得MBC特定的QoL资源和干预措施。然而，在这方面， 对于MBC患者的生活质量随时间的变化知之甚少。纵向生活质量数据，确实存在的pri- 这些试验来自药物临床试验，有两个关键的局限性。首先，临床试验可能包括 选择的，功能更高的个体，没有显著的合并症;因此，研究结果可能不会推广到 更广泛的MBC人口。其次，临床试验通常在与治疗一致的时间点评估QoL 自行车.关于治疗周期之间QoL变化的数据很少。拟议的研究涉及 通过收集MBC患者的纵向生活质量数据，在文献中发现了这一差距。关于QoL的深入数据 MBC患者的担忧和干预偏好将使我们能够适应和应用现有的治疗方案， 对这一群体进行口头干预，他们经常被排除在癌症生存研究之外。我们的长期目标是 通过行为干预来支持MBC患者的体验。然而，额外的数据 为了确定这种干预的最佳内容和时机，需要对生活质量进行评估。因此， 本申请的目的是收集MBC中QoL的深入纵向观察数据。实现这一 为了达到这一目标，我们将采用混合方法实现两个具体目标。在目标1中，我们将使用创新的生态 瞬时评估（EMA）测量-爆发方案，以收集女性样本的QoL数据， MBC（N=120）。EMA涉及在真实的时间内对受试者当前经历的重复采样， 环境.测量突发设计结合了短周期（即，强化评估 其在较长的间隔上纵向重复（即，周）。在拟议的研究中，参与者将- 连续四周每周一次完成EMA爆发（3次提示/天）。EMA爆发将评估总体 生活质量和症状严重程度（焦虑、抑郁、疲劳、疼痛干扰和身体功能）。在目标2中， 将对目标1参与者（N=10）进行深入的个人定性访谈， 评估参与者对EMA协议的体验以及他们对未来干预的偏好。我们将 还探讨了自我监控对参与者MBC生活经历的潜在影响。拟议 研究将为未来的试验提供试点数据，以适应现有的针对QoL的行为干预， 转移性乳腺癌的癌症幸存者，并测试适应性干预的功效。该方案 研究有可能增加我们对这一人群生活质量的理解，最终使我们能够 确定有针对性的干预策略，以改善生活质量和减少痛苦。

PROJECT SUMMARY Despite advances in breast cancer prevention and treatment, thousands of people are either newly-diagnosed with or progress to metastatic breast cancer (MBC). MBC can lead to significant decrements in quality of life (QoL), a multidimensional construct including physical and emotional well-being. Given the incurable nature of MBC, QoL is a critical outcome. Furthermore, data from our group and others demonstrate that individuals living with MBC have unmet needs related to QoL and desire MBC-specific QoL resources and interventions. However, little is known about changes in QoL over time in those with MBC. The longitudinal QoL data that do exist pri- marily come from pharmaceutical clinical trials, and have two key limitations. First, clinical trials may include selected, higher-functioning individuals with no significant comorbidities; thus, findings may not generalize to the broader MBC population. Second, clinical trials typically assess QoL at time points that align with treatment cycles. There is little data on changes in QoL between cycles of treatment. The proposed research addresses this gap in the literature by collecting longitudinal QoL data from people living with MBC. In-depth data on QoL concerns and intervention preferences of individuals with MBC will allow us to adapt and apply existing behav- ioral interventions to this group, who are often excluded from cancer survivorship studies. Our long-term goal is to support the experience of those living with MBC through behavioral interventions. However, additional data on QoL are needed in order to identify the optimal content and timing of such interventions. Thus, the overall objective of this application is to collect in-depth longitudinal, observational data on QoL in MBC. To achieve this objective, we will pursue two specific aims using mixed methods. In Aim 1, we will use an innovative ecological momentary assessment (EMA) measurement-burst protocol to collect QoL data in a sample of females with MBC (N=120). EMA involves repeated sampling of subjects’ current experiences in real time, in subjects’ natural environments. The measurement-burst design incorporates short periods (i.e., days) of intensive assessments that are repeated longitudinally over longer intervals (i.e., weeks). In the proposed study, participants will com- plete EMA bursts (3 prompts/day) once per week for four consecutive weeks. EMA bursts will assess overall QoL and symptom severity (anxiety, depression, fatigue, pain interference, and physical function). In Aim 2, we will conduct in-depth individual qualitative interviews with a convenience sample of Aim 1 participants (N=10) to assess participants’ experiences with the EMA protocol and their preferences for a future intervention. We will also explore the potential impact of self-monitoring on participants’ lived experiences with MBC. The proposed study will provide pilot data for a future trial to adapt an existing behavioral intervention targeting QoL among cancer survivors for metastatic breast cancer, and test the efficacy of the adapted intervention. This program of research has the potential to increase our understanding of QoL in this population, ultimately enabling us to identify targeted intervention strategies to improve QoL and reduce suffering.