Physician Use of Patient-Reported Daily Diary Data in Decisions about Phase II Tr

医生在做出第二阶段治疗决策时使用患者报告的每日日记数据

• 批准号: 8108063
• 负责人: Felicity Harper
• 金额: $ 20.79万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8108063
• 关键词: Address; Adherence; Affect; Cancer Patient; Cell Death; Clinic Visits; Clinical; Clinical Data; Clinical Treatment; Clinical Trials; Comprehensive Cancer Center; Cytostatics; Data; Decision Making; Devices; Disease; Electronics; Fatigue; Frequencies; Goals; Home environment; Individual; Intervention; Judgment; Lead; Life; Malignant neoplasm of prostate; Manuals; Mental Depression; Methodology; Methods; Outcome; Outcome Assessment; Pain; Paper; Patient Outcomes Assessments; Patient Self-Report; Patients; Personal Satisfaction; Phase; Phase II Clinical Trials; Physicians; Policies; Process; Quality of life; Reading; Records; Relative (related person); Reporting; Research Personnel; Sampling; Series; Solutions; Staging; Symptoms; Testing; Time; Toxic effect; Validity and Reliability; Visual; Weight; Work; base; cell growth; design; diaries; experience; improved; innovation; novel; response; therapy development; treatment trial; tumor

DESCRIPTION (provided by applicant): Cancer patients' responses to clinical trial treatments are often hard to define and are becoming more so as an increasing number of novel treatment agents (e.g., cytostatic agents) are developed. Objective clinical endpoints often fail to capture the full impact of treatment on patients. Yet patients' symptoms can have a direct impact on patients' daily life, general well-being, and even adherence to treatment. Thus, physicians are looking to patient-reported outcomes (PROs). However, traditional methods of collecting PROs (e.g., retrospective recall) are limited by reliability and validity issues. The use of Ecological Momentary Assessment (EMA) devices (i.e., electronic "daily diaries") addresses many of these issues by providing physicians with patients' own reports of daily changes in treatment-relevant outcomes such as quality of life. We propose a longitudinal, daily diary study to: (a) better understand intra- and inter-individual variability in patient-reported quality of life (PRQOL) for patients on Phase II clinical trials for prostate cancer, and (b) investigate how physicians use PRQOL information to make treatment decisions. Our pilot work shows that clinical trial patients, even those with stage 4 disease, are able to use EMA devices to complete daily PRQOL reports over extended periods of time with high completion rates. In the current study, our first objective is to evaluate the feasibility of using electronic diaries in a larger, more racially diverse sample of patients. To accomplish this goal, we will use EMA devices to collect daily PRQOL from 60 prostate cancer patients who are participating in Phase II treatment trials at an urban, comprehensive cancer center. Our second objective is to identify correlates of inter- and intra-individual variability in PRQOL and gain a better understanding of why patients may differ in their reports of QOL over time. Our third objective is to conduct a pilot intervention in which we use a two-condition, interupted times-series design to manipulate the type of patient QOL data available to physicians and examine whether the type of QOL data available in the different conditions affect physicians' use of patient QOL in decisions to stop or continue treatment. To do this, we will use a "policy capturing" methodology to estimate the relative weight that physicians assign to subjective PRQOL data and objective clinical data in their treatment decisions for prostate cancer patients in Phase II treatment trials. The significance of this study is in better understanding how clinical trial treatment impacts PRQOL and how physicians use PRQOL in treatment decisions. The innovative aspects of this study are (a) the use of EMA devices to collect PRQOL in response to treatment, and (b) the manipulation of the type of patient QOL data (self-reported by patients or physician-observed) available to physicians during clinic visits. The results of this study will inform the development of interventions to facilitate how PRQOL is collected and assist physicians in integrating PROs with objective clinical data, thereby leading to more informed and participatory treatment decision-making between patient and physician. PUBLIC HEALTH RELEVANCE: Physicians are increasingly looking to patients' reports of symptoms to understand how patients are affected by experimental treatments. Using electronic diaries to report symptoms, patients can provide physicians with an accurate picture of how they are affected by treatment on a daily basis. In the current study, we will explore variability in patients' daily reports of quality of life and how physicians use these reports to make decisions about treatment for prostate cancer patients in Phase II trials. Findings will be used to inform the development of interventions to help physicians integrate patient-reported information with objective clinical data, thereby improving this important treatment decision-making process.

描述（由申请人提供）：癌症患者对临床试验治疗的反应通常很难定义，并且随着越来越多的新型治疗剂（例如细胞抑制剂）的开发，这种反应变得更加明显。客观的临床终点通常无法捕捉治疗对患者的全部影响。然而，患者的症状可能会直接影响患者的日常生活、总体健康状况，甚至对治疗的依从性。因此，医生正在关注患者报告的结果（PRO）。然而，收集 PRO 的传统方法（例如回顾性​​回忆）受到可靠性和有效性问题的限制。使用生态瞬时评估 (EMA) 设备（即电子“每日日记”）可以为医生提供患者自己的治疗相关结果（例如生活质量）每日变化的报告，从而解决了许多此类问题。 我们提出一项纵向每日日记研究，以：(a) 更好地了解前列腺癌 II 期临床试验患者的患者报告生活质量 (PRQOL) 的个体内和个体间差异，以及 (b) 调查医生如何使用 PRQOL 信息做出治疗决策。我们的试点工作表明，临床试验患者，即使是患有 4 期疾病的患者，也能够使用 EMA 设备在较长时间内以较高的完成率完成每日 PRQOL 报告。在当前的研究中，我们的首要目标是评估在更大、种族更多样化的患者样本中使用电子日记的可行性。为了实现这一目标，我们将使用 EMA 设备收集 60 名在城市综合癌症中心参加 II 期治疗试验的前列腺癌患者的每日 PRQOL。我们的第二个目标是确定 PRQOL 个体间和个体内变异的相关性，并更好地理解为什么患者的 QOL 报告随着时间的推移可能会有所不同。我们的第三个目标是进行试点干预，其中我们使用两种条件、间断时间序列设计来操纵医生可用的患者生活质量数据类型，并检查不同条件下可用的生活质量数据类型是否会影响医生的治疗效果。使用患者的生活质量来决定停止或继续治疗。为此，我们将使用“策略捕获”方法来估计医生在 II 期治疗试验中对前列腺癌患者的治疗决策中主观 PRQOL 数据和客观临床数据的相对权重。 这项研究的意义在于更好地了解临床试验治疗如何影响 PRQOL 以及医生如何在治疗决策中使用 PRQOL。本研究的创新点是 (a) 使用 EMA 设备收集治疗后的 PRQOL，以及 (b) 操纵医生可获得的患者 QOL 数据类型（患者自我报告或医生观察）就诊期间。这项研究的结果将为干预措施的制定提供信息，以促进如何收集 PRQOL，并协助医生将 PRO 与客观临床数据相结合，从而在患者和医生之间做出更明智和参与性的治疗决策。 公共卫生相关性：医生越来越多地关注患者的症状报告，以了解实验性治疗对患者的影响。使用电子日记报告症状，患者可以向医生提供准确的信息，了解他们每天受到治疗的影响。在当前的研究中，我们将探讨患者每日生活质量报告的变异性，以及医生如何使用这些报告来制定 II 期试验中前列腺癌患者的治疗决策。研究结果将用于为干预措施的制定提供信息，以帮助医生将患者报告的信息与客观的临床数据相结合，从而改善这一重要的治疗决策过程。