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.
The proposed pilot study will describe the experiences of veterans undergoing acupuncture therapy for symptoms of hepatitis C (HCV) and antiviral therapy. In addition, the study will evaluate the appropriateness of a larger scale evaluation of the use of acupuncture for symptom management. This proposal will include evaluating recruitment strategies, acceptability, and adherence to the protocol. We will be able to compare the quantitative and qualitative data to see what information the quantitative measures do not capture and allow us to refine our measures. Acupuncture has the potential to improve the management of symptoms commonly experienced by veterans with HCV and by veterans undergoing antiviral therapy. Improving a veteran's ability to adhere to the antiviral treatment regimen has the potential to improve the veteran's treatment outcome and quality of life.
