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

NCT ID: NCT00794911

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

Chronic HCV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

QOLT

Quality of Life Therapy (QOLT) 8 weekly individual counseling sessions.

Group Type: EXPERIMENTAL

Quality of Life Therapy

Intervention Type: BEHAVIORAL

8 weekly individual counseling sessions

ST

Supportive Therapy (ST) 8 weekly individual counseling sessions

Group Type: ACTIVE_COMPARATOR

Supportive Therapy

Intervention Type: BEHAVIORAL

8 weekly individual counseling sessions

Standard Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Quality of Life Therapy

8 weekly individual counseling sessions

Intervention Type: BEHAVIORAL

Supportive Therapy

8 weekly individual counseling sessions

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

James Rodrigue

Professor of Psychology in the Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James R Rodrigue, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2007P000171

Identifier Type: -

Identifier Source: org_study_id

NCT00794937

Identifier Type: -

Identifier Source: nct_alias