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: 10512667
• 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/10512667
• 关键词: Address; Anxiety; Behavior Therapy; Breast Cancer Prevention; CDK4 gene; Cancer Survivor; Cancer Survivorship; Clinical; Clinical Trials; Cognitive Therapy; Computers; Data; Deterioration; Development; Diagnosis; Ecological momentary assessment; Effectiveness; Environment; Fatigue; Female; Future; General Population; Goals; Individual; Information Systems; Intervention; Interview; Lead; Life; Literature; Malignant Neoplasms; Measurement; Mental Depression; Metastatic breast cancer; Metastatic to; 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; Quality-of-Life Assessment; 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.

项目概要 尽管乳腺癌的预防和治疗取得了进展，但仍有数千人是新诊断的 患有或进展为转移性乳腺癌 (MBC)。 MBC 可导致生活质量显着下降 (QoL)，一个包括身体和情感健康的多维结构。鉴于该病的不治之症的性质 MBC、QoL 是一个关键结果。此外，我们小组和其他人的数据表明，生活在 MBC 的生活质量相关需求未得到满足，并希望获得 MBC 特定的生活质量资源和干预措施。然而， 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 主要来自药物临床试验，并且有两个关键限制。首先，临床试验可能包括 选定的、功能较高且无明显合并症的个体；因此，研究结果可能无法推广到 更广泛的 MBC 人群。其次，临床试验通常在与治疗相符的时间点评估生活质量 循环。关于治疗周期之间生活质量变化的数据很少。拟议的研究地址 通过收集 MBC 患者的纵向生活质量数据来弥补文献中的空白。有关生活质量的深入数据 MBC 患者的担忧和干预偏好将使我们能够适应和应用现有的行为 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 患者的经历。然而，额外的数据 需要对生活质量进行评估，以确定此类干预措施的最佳内容和时机。因此，总体 此应用程序的目的是收集有关 MBC 生活质量的深入纵向观察数据。为了实现这一目标 目标，我们将使用混合方法来实现两个具体目标。在目标1中，我们将使用创新的生态 瞬时评估 (EMA) 测量爆发协议，用于收集患有以下疾病的女性样本中的生活质量数据 MBC（N=120）。 EMA 涉及以受试者的自然状态对受试者当前的经历进行实时重复采样。 环境。突发测量设计包含短期（即几天）的密集评估 在较长的时间间隔（即几周）内纵向重复。在拟议的研究中，参与者将包括 连续四个星期，每周一次完整的 EMA 爆发（每天 3 次提示）。 EMA 爆发将评估整体 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 将与目标 1 参与者（N = 10）的方便样本进行深入的个人定性访谈，以 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 生活体验的潜在影响。拟议的 研究将为未来的试验提供试点数据，以调整现有的针对生活质量的行为干预措施 转移性乳腺癌的癌症幸存者，并测试调整后的干预措施的有效性。这个节目的 研究有可能增加我们对这一人群生活质量的了解，最终使我们能够 确定有针对性的干预策略，以改善生活质量并减少痛苦。