Quality of Life Therapy for Adults With Hepatitis C Virus and Cirrhosis Awaiting Liver Transplantation

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.

Inclusion Criteria:

- Male or female patients between 21 and 70 years of age

- Diagnosis of chronic HCV

- Wait-listed for liver transplantation

- Signed informed consent

- Primary caregiver identified as spouse or domestic partner

- Resides within 60 minutes of transplant center

- MELD score < 20

Exclusion Criteria:

- Prior recipient of liver transplantation

- Prior recipient of other solid organ transplantation

- Wait-listed for combined liver-kidney transplantation

- Current substance abuse or dependency

- Currently hospitalized

- Sustained (2 or more consecutive months) MELD score less than or equal to 20

- Current recipient of psychological intervention services

- Substantial cognitive impairment (score of 23 or less on the Mini-Mental State
Examination)

- Communication difficulties (speech, hearing) so substantial that they would prevent
patient from participating actively in one of the interventions (determined by
interviewer rating)