Uncertainty and Watchful Waiting in Chronic Hepatitis C

描述(申请人提供)：丙型肝炎病毒(丙型肝炎病毒)是美国最常见的血液传播感染，每年影响至少400万人，新增病例超过3.5万例。此外，高达85%的急性丙型肝炎患者将发展为慢性丙型肝炎；美国疾病控制与预防中心预测，1990年至2015年期间，慢性丙型肝炎患者的数量将增加四倍。许多慢性丙型肝炎患者是干扰素联合治疗的潜在候选者，选择治疗的患者中约有50%将出现持续的病毒应答(SVR)。然而，对于无症状的患者、合并疾病的患者和年龄较大的患者，治疗的好处不太明显。此外，治疗还伴随着严重的副作用，如抑郁和过度疲劳，由于这些副作用和治疗效果有限，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。这项拟议的为期3年的探索性纵向描述性研究将在18个月的时间内检查CHC患者疲劳、肌肉骨骼主诉、抑郁和生活质量的轨迹。我们还将检查人口统计学变量、疾病标记物和疾病不确定性与这些轨迹的关联。具体目标是：1)在观察、等待和监测的患者中，确定CHC相关症状和生活质量的潜在不同的轨迹类别(例如，稳定、下降，或改善)，并确定与特定变化轨迹相关的人口统计学和疾病标记物；2)检查这些症状轨迹和QOL与疾病不确定性的关联；以及3)探索慢性丙型肝炎患者的担忧，这些担忧可能是独特的，可能无法通过量化措施解决。样本将包括120名说英语的男性和未怀孕的女性，他们被诊断出患有CHC，并在杜克大学肝脏诊所接受他们的护理。将采用定量和定性相结合的方法对数据进行分析。这种疾病的新鲜性、描述性研究的缺乏以及对CHC患者的护理干预试验的缺乏令人担忧。对于CHC患者来说，在不确定条件下观察、等待和监测是一个关键问题，这项研究将提供关于他们的症状和生活质量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，这些知识将被用来改进针对观察等待的不确定性管理干预，该干预已成功地用于患有前列腺癌的老年男性，用于未来在这些慢性丙型肝炎患者中进行测试。

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.