Ecological Momentary Assessment of Quality of Life in Metastatic Breast Cancer

转移性乳腺癌生活质量的生态瞬时评估

• 批准号: 10677003
• 负责人: Claire C Conley
• 金额: $ 7.8万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-04 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10677003
• 关键词: Acceleration; Address; Anxiety; Behavior Therapy; Breast Cancer Prevention; CDK4 gene; Cancer Survivor; Cancer Survivorship; Clinical; Clinical Trials; Cognitive Therapy; Computers; Data; Deterioration; Development; Diagnosis; Dimensions; Ecological momentary assessment; Effectiveness; Environment; Exclusion; Fatigue; Female; Future; General Population; Goals; Individual; Information Systems; Intervention; Interview; Life; Literature; Malignant Neoplasms; Measurement; Mental Depression; Metastatic breast cancer; Methods; Monitor; Nature; Neoplasm Metastasis; Newly Diagnosed; Oral; Outcome; Pain interference; Participant; Patient Outcomes Assessments; Pattern; Persons; Pharmacologic Substance; Physical Function; Population; Protocols documentation; Quality of Life Assessment; Quality of life; Recurrence; Reporting; Research; Resources; Sampling; Severities; Supportive care; Symptoms; Testing; Time; Well in self; breast cancer diagnosis; cancer therapy; chemotherapy; clinically significant; comorbidity; design; efficacy testing; evidence base; experience; functional decline; improved; inhibitor; innovation; interest; malignant breast neoplasm; mindfulness intervention; physical symptom; preference; programs; psychological symptom; symptom management; symptomatic improvement

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.

项目总结 尽管乳腺癌的预防和治疗取得了进展，但仍有成千上万的人要么是新诊断出来的 患有或进展为转移性乳腺癌(MBC)。MBC会导致生活质量的显著下降 (QOL)，一个包括身体和情感幸福感的多维结构。鉴于不治之症的本质 MBC，QOL是一个关键的结果。此外，来自我们小组和其他人的数据表明，生活在 与MBC有未满足的与QOL相关的需求，并渴望MBC特定的QOL资源和干预。然而， 关于MBC患者随着时间的推移，生活质量的变化我们知之甚少。确实存在的纵向QOL数据主要是- Marly来自药物临床试验，并有两个关键限制。首先，临床试验可能包括 选定的、功能较高的个体没有明显的共病；因此，研究结果可能不能推广到 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生活质量 循环。关于两个治疗周期之间的生活质量变化的数据很少。建议的研究内容包括 通过收集MBC患者的纵向生活质量数据，发现了文献中的这一差距。关于服务质量的深入数据 MBC患者的担忧和干预偏好将使我们能够适应和应用现有行为- 对这一群体的社会干预，他们经常被排除在癌症存活率研究之外。我们的长期目标是 通过行为干预来支持MBC携带者的体验。然而，其他数据 为了确定此类干预的最佳内容和时机，需要对生活质量进行评估。因此，总体上， 这项应用的目的是收集关于MBC患者生活质量的深入纵向观察数据。要做到这一点 目标，我们将使用混合方法追求两个特定的目标。在目标1中，我们将使用创新的生态 瞬间评估(EMA)测量-突发协议收集患有以下疾病的女性样本的生活质量数据 MBC(N=120)。EMA包括对受试者的当前体验进行实时、自然的重复采样 环境。测量突发设计包含短时间段(即数天)的密集评估 它们在更长的间隔(即，几周)上纵向重复。在拟议的研究中，参与者将- 连续四周每周进行一次EMA脉冲(每天3次提示)。EMA突发事件将评估整体 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，我们 将对目标1参与者(N=10)进行深入的个人定性访谈，以 评估参与者使用EMA方案的经验以及他们对未来干预的偏好。我们会 同时探讨自我监控对参与者在MBC中的生活体验的潜在影响。建议数 这项研究将为未来的试验提供试点数据，以适应针对生活质量的现有行为干预 癌症存活者为转移性乳腺癌，并测试适应干预的疗效。这是一项 研究有可能增加我们对这一人群中的生活质量的了解，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。