Uncertainty and Watchful Waiting in Chronic Hepatitis C

慢性丙型肝炎的不确定性和观察等待

• 批准号: 7011949
• 负责人: Donald E Bailey
• 金额: $ 23.25万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7011949
• 关键词: age difference; behavioral /social science research tag; chronic disease /disorder; clinical research; comorbidity; data collection methodology /evaluation; depression; fatigue; gender difference; health behavior; health care policy; hepatitis C; hepatitis C virus; human subject; interview; longitudinal human study; medical complication; musculoskeletal disorder; patient care management; psychological stressor; quality of life; questionnaires; racial /ethnic difference; therapy design /development

DESCRIPTION (provided by applicant): Hepatitis C Virus (HCV), the most common blood blood-borne infection in the U.S., affects at least 4 million individuals with more than 35,000 new cases occurring each year. Further, up to 85% of those with acute HCV will develop chronic hepatitis C (CHC); the CDC has projected a fourfold increase in the number of CHC patients between 1990 and 2015. Many CHC patients are potential candidates for treatment with combination interferon therapy and approximately 50% of patients electing treatment will have a sustained viral response (SVR). However, the benefits of therapy are less clear for asymptomatic patients, those with co-morbid illnesses and older patients. Further, treatment has been associated with severe side effects such as depression and excessive fatigue, and because of these side effects and the limited efficacy of treatment, 40% of patients discontinue therapy and 10% forego therapy. Thus approximately 50% of CHC patients are not undergoing active treatment but instead are watching, waiting, and monitoring their disease. The proposed 3 year exploratory longitudinal descriptive study will examine the trajectories of CHC patients' fatigue, musculoskeletal complaints, depression, and QOL over an 18-month period. We will also examine the associations of demographic variables, illness markers, and illness uncertainty with these trajectories. The specific aims are to: 1) identify potentially distinct classes of trajectories (e.g., stable, declining, perhaps improving) of CHC-related symptoms and quality of life among patients who are watching, waiting and monitoring, and to identify the demographic and illness markers associated with particular trajectories of change; 2) examine the associations of these symptom trajectories and QOL with illness uncertainty; and 3) explore the concerns of patients living with chronic hepatitis C that may be unique and unaddressed with quantitative measures. The sample will consist of 120 English speaking men and non- pregnant women who have been diagnosed with CHC and receive their care at the Duke Liver Clinic. Quantitative and qualitative methods will be used to analyze the data. The newness of the disease, the paucity of descriptive studies, and absence of nursing intervention trials for CHC patients is alarming. Watching, waiting, and monitoring under conditions of uncertainty is a critical issue for patients with CHC and this study will provide the first descriptive data on their symptom and QOL trajectories and thus new knowledge for practitioners and policy makers. In addition, this knowledge will be used to refine an Uncertainty Management Intervention for Watchful Waiting, which has been successfully used with elderly men with prostate cancer, for future testing among these CHC patients.

描述（由申请人提供）：丙型肝炎病毒（HCV），美国最常见的血液血源性感染，至少影响400万人，每年发生35 000多起新病例。此外，高达85%的急性HCV患者将发展为慢性丙型肝炎（CHC）; CDC预测1990年至2015年期间CHC患者数量将增加四倍。许多CHC患者是干扰素联合治疗的潜在候选者，约50%选择治疗的患者将具有持续病毒应答（SVR）。然而，对于无症状患者、患有合并症的患者和老年患者来说，治疗的好处并不清楚。此外，治疗与严重的副作用如抑郁和过度疲劳有关，由于这些副作用和治疗的有限功效，40%的患者停止治疗，10%的患者放弃治疗。因此，大约50%的CHC患者没有接受积极的治疗，而是在观察、等待和监测他们的疾病。拟议的3年探索性纵向描述性研究将检查CHC患者在18个月期间的疲劳、肌肉骨骼主诉、抑郁和QOL的轨迹。我们还将研究人口统计学变量，疾病标志物和疾病不确定性与这些轨迹的关联。具体目标是：1）识别可能不同的轨迹类别（例如，稳定，下降，可能改善）的CHC相关症状和生活质量的患者谁是看，等待和监测，并确定人口统计学和疾病标志物与特定的变化轨迹; 2）检查这些症状轨迹和生活质量与疾病的不确定性的关联;和3）探讨慢性丙型肝炎患者的关注点，这些关注点可能是独特的，无法用定量方法解决。样本将由120名讲英语的男性和非孕妇组成，他们被诊断患有CHC，并在杜克肝脏诊所接受护理。将使用定量和定性方法分析数据。这种疾病的新性，描述性研究的缺乏，以及缺乏对CHC患者的护理干预试验是令人担忧的。在不确定的条件下观察，等待和监测是CHC患者的一个关键问题，本研究将提供有关其症状和QOL轨迹的第一个描述性数据，从而为从业者和政策制定者提供新的知识。此外，这些知识将用于完善观察等待的不确定性管理干预，该干预已成功用于患有前列腺癌的老年男性，用于这些CHC患者的未来测试。