Acupuncture for Symptom Management in Veterans with Hepatitis C

描述（由申请人提供）： 拟议的混合方法初步研究的主要目的是描述两组患有丙型肝炎（HCV）的退伍军人的经验：（1）患有HCV但未接受抗病毒治疗的退伍军人和（2）患有HCV并正在接受抗病毒治疗的退伍军人。另一个目的是确定8周针灸计划在管理两组常见症状方面的可接受性和可行性。这项试点研究将使我们能够计算一个全面的试验样本量。我们还将确定针灸治疗是否有足够的益处，以保证进一步的随机对照试验研究。本研究将采用定性和定量方法，采用前瞻性描述性纵向设计。混合方法是合理的，因为这两种方法相互补充，定量和定性数据的结合使用，可以更深入地了解使用针灸来管理丙型肝炎病毒感染者和接受抗病毒治疗的丙型肝炎病毒感染者通常经历的症状的可接受性和可行性。研究目标1：使用定性方法描述（1）未接受抗病毒治疗的HCV退伍军人和（2）接受抗病毒治疗的HCV退伍军人接受针灸治疗进行症状管理的经验。研究目标2：探讨和描述针灸治疗对（1）未接受抗病毒治疗的HCV退伍军人和（2）接受抗病毒治疗的HCV退伍军人症状管理的可接受性和可行性。研究目标3：探索和描述症状（抑郁，疼痛和疲劳）随时间的变化，针灸后（1）退伍军人与HCV和谁没有接受抗病毒治疗和（2）退伍军人与HCV谁正在接受抗病毒治疗。项目方法：方便样本将包括20名退伍军人与丙型肝炎病毒和20名退伍军人与丙型肝炎病毒正在接受抗病毒治疗。将使用简明疲劳量表（c）（BFI）、视觉疼痛量表（VAS 100）、流行病学研究中心抑郁量表（CES-D）、记忆症状评估量表-简表（MSAS-SF）和VR-36获得定量数据。将在12周内从20名HCV患者和20名接受抗病毒治疗的HCV患者中收集数据。将从较大定量样本的子集中收集定性数据。每个人每周将参加两次针灸课程，共8周。针灸将在一组设置中进行。将在基线、第2、4、6、8周收集结果，参与者将在最后一次针灸后的第1周和第2周完成问卷包。定性数据将从较大定量样本的个体子集中收集。将对8-10名HCV感染者和8-10名接受抗病毒治疗的HCV感染者进行访谈。第一次访谈将在第一次针灸治疗前进行，第二次访谈将在针灸干预的第6周至第8周之间进行。作为我们评估针灸治疗HCV患者症状的可行性的一部分，我们将测量治疗（针灸）的依从性。将获得两个研究组的数据。定性数据将使用内容分析进行分析。

DESCRIPTION (provided by applicant): The primary aim of the proposed mixed method pilot study is to describe the experience of two groups of Veterans with hepatitis C (HCV): (1) Veterans that have HCV, but who are not undergoing antiviral treatment and (2) Veterans that have HCV and who are receiving antiviral treatment. An additional aim is to determine the acceptability and feasibility of an 8 week acupuncture program in managing symptoms commonly experienced by both groups. This pilot study will allow us to calculate a sample size for a full-scale trial. We will also establish whether there is sufficient benefit from acupuncture therapy to warrant further study with a randomized control trial. The study will use a prospective descriptive longitudinal design using qualitative and quantitative methods. Mixed methods are justified for this study because the two methods complement each other and the combined use of quantitative and qualitative data allows for a more in-depth understanding of the acceptability and feasibility of using acupuncture to manage the symptoms commonly experienced by individuals with HCV and individuals with HCV on antiviral therapy. Research Aim #1: To describe, using qualitative methods, the experience of undergoing acupuncture therapy for symptom management in (1) Veterans with HCV and who are not receiving antiviral therapy and (2) Veterans with HCV who are receiving antiviral therapy. Research Aim #2: To explore and describe the acceptability and feasibility of acupuncture therapy for symptom management in (1) Veterans with HCV and who are not receiving antiviral therapy and (2) Veterans with HCV who are receiving antiviral therapy. Research Aim #3: To explore and describe symptom (depression, pain, and fatigue) changes over time following acupuncture in (1) Veterans with HCV and who are not receiving antiviral therapy and (2) Veterans with HCV who are receiving antiviral therapy. Project Methods: The convenience sample will include 20 veterans with HCV and 20 veterans with HCV undergoing antiviral therapy. Quantitative data will be obtained using the Brief Fatigue Inventory(c) (BFI), Visual Analogue Pain Scale (VAS 100), Center for Epidemiological Studies Depression Scale (CES-D), Memorial Symptom Assessment Scale- short form (MSAS-SF) and VR-36. Data will be collected over a period of 12 weeks from 20 individuals with HCV and 20 individuals with HCV undergoing antiviral therapy. Qualitative data will be collected from a subset of the larger quantitative sample. Individuals will attend two acupuncture sessions each week for a total of 8 weeks. The acupuncture will be administered in a group setting. Outcomes will be collected at baseline, weeks 2, 4, 6, 8, and participants will complete a questionnaire packet at weeks 1 and 2 after the final acupuncture session. Qualitative data will be collected from a subset of individuals of the larger quantitative sample. A total of 8-10 individuals with HCV and 8-10 individuals with HCV undergoing antiviral therapy will be interviewed. The first interview will take place before the first acupuncture session and the second between week 6 and 8 of the acupuncture intervention. As part of our assessment of the feasibility of acupuncture therapy for symptoms in HCV patients, we will measure compliance with treatment (acupuncture). These will be obtained for each of the two study groups. Qualitative data will be analyzed using content analysis.