Clinical trial NCT00794911: Quality of Life Therapy for Adults With Hepatitis C Virus and Cirrhosis Awaiting Liver Transplantation
Official title: Quality of Life Therapy for Adults With Hepatitis C Virus and Cirrhosis Awaiting Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic HCV
Keywords: Liver Transplantation
Quality of Life
Chronic HCV
Hepatitis C Virus
Cirrhosis
Liver disease
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2008-11-20
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Scores on the following measures at 12 weeks post-intervention: Quality of Life Inventory, SF-36, Liver Disease Quality of Life instrument, CDC's Activity Limitations Module HRQoL-14, Hopkins Symptom Checklist-25, POMS, and Miller Social Intimacy Scale.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: James R Rodrigue, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: