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: 8322035
• 负责人: Felicity Harper
• 金额: $ 16.96万
• 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 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8322035
• 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.

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）的发展而变得越来越多。客观的临床终点通常无法捕获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，一般福祉，甚至遵守治疗。因此，医生正在寻求患者报告的结果（专业人士）。但是，传统的收集专业人士（例如回顾性​​召回）受到可靠性和有效性问题的限制。生态瞬时评估（EMA）设备（即电子“每日日记”）的使用，通过向医生提供患者自己每天有关治疗相关结果（例如生活质量）的每日变化的报告来解决其中许多问题。 我们建议一项纵向，每日日记研究：（a）更好地了解患者报告的生活质量（PRQOL）的患者对II期临床试验的患者生活质量（PRQOL）的个人间变异性，以及（b）研究医师如何使用PRQOL信息来做出治疗决策。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设备在长时间内完成每日PRQOL报告，并以高完成率完成。在当前的研究中，我们的第一个目标是评估在较大，种族多样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设备从参加城市，综合癌症中心参加II期治疗试验的60名前列腺癌患者中收集每日PRQOL。我们的第二个目标是确定PRQOL中个体间和个体内变异性的相关性，并更好地了解患者为什么随着时间的推移对QOL的报告有所不同。我们的第三个目标是进行试验干预措施，在该干预中，我们使用两组，间断的时间系列设计来操纵医生可用的患者QOL数据类型，并检查在不同条件下可用的QOL数据类型是否会影响医生在决策中使用患者QOL来停止或继续治疗。为此，我们将使用一种“捕获”方法来估计医师在其在II期治疗试验中为前列腺癌患者的治疗决策中分配给主观PRQOL数据和客观临床数据的相对体重。 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。这项研究的创新方面是（a）使用EMA设备收集PRQOL以响应治疗，以及（b）在诊所就诊期间可用于医生可用于医生的患者QOL数据类型（由患者或医生观察的）操纵。这项研究的结果将为干预措施的发展提供信息，以促进PRQOL的收集方式，并协助医生将专业人士与客观的临床数据相结合，从而导致患者和医师之间更多知识和参与的治疗决策。