Quality of Life Therapy for Adults With Hepatitis C Virus and Cirrhosis Awaiting Liver Transplantation
Condition: Chronic HCV
MeSH terms: Hepatitis C; Hepatitis; Fibrosis
Study type: Interventional

Summary: 
      The main purpose of this study is to determine whether psychological intervention is
      effective in improving quality of life, mood, and relationships among adults with hepatitis C
      virus and cirrhosis awaiting liver transplantation.
    

Detailed description: 
      Quality of life (QOL) outcomes are important to all stakeholders in liver transplantation.
      For patients with end-stage liver disease, QOL is significantly compromised and more data
      about QOL allows them to make an informed risk-benefit analysis in deciding whether to pursue
      transplantation. The long-term goal of this research program is to better understand how QOL
      can be enhanced, to identify the mechanisms underlying QOL changes, to identify which
      patients benefit most from QOL intervention, and to determine whether QOL benefits can extend
      beyond transplantation. The objective of this research is to determine the effectiveness,
      feasibility and applicability of Quality of Life Therapy (QOLT) in treating adults with
      hepatitis C virus and cirrhosis awaiting liver transplantation. In a recent small,
      single-center clinical trial, we demonstrated that QOLT can improve QOL, psychological
      functioning, and social intimacy in patients awaiting lung transplantation. We now seek to
      examine whether this intervention can be effectively adapted and implemented with adults with
      hepatitis C virus and cirrhosis awaiting liver transplantation. The central hypothesis is
      that by targeting improvements in specific life domains, QOLT yields significant clinical
      benefits in QOL, psychological functioning, and the patient-caregiver relationship. This
      hypothesis is being tested by pursuing three specific aims: 1) Determine the effectiveness of
      QOLT; 2) Examine the differential effectiveness of QOLT by race (White, African American);
      and 3) Assess the feasibility of a multisite R01 application. Under the first aim, adults
      with hepatitis C virus and cirrhosis awaiting liver transplantation are being randomized to
      receive QOLT, Supportive Therapy (ST), or Standard Care (SC). Primary outcomes are changes in
      QOL, psychological functioning, and social intimacy at 1 and 12 weeks post-treatment. Under
      the second aim, the relationship between race and intervention outcomes will be closely
      examined. Under the third aim, attrition rates, reasons for attrition, therapist adherence to
      treatment protocols, and participant satisfaction ratings are being gathered to assess the
      need for protocol changes prior to developing a larger, multisite clinical trial R01
      application. This study is innovative because it is among the first to evaluate a
      theoretically-driven psychological intervention to specifically improve QOL in the context of
      hepatitis C virus and cirrhosis and liver transplantation. The research is significant
      because it is expected to advance and expand understanding of how QOL can be improved in
      patients with hepatitis C virus and cirrhosis.
    

Intervention name(s): Quality of Life Therapy; Supportive Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 weekly individual counseling sessions; 8 weekly individual counseling sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Liver Transplantation; Quality of Life; Chronic HCV; Hepatitis C Virus; Cirrhosis; Liver disease