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

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00794911
First received: November 19, 2008
Last updated: March 9, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Chronic HCV
Behavioral: Quality of Life Therapy
Behavioral: Supportive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Quality of Life Therapy for Adults With Hepatitis C Virus and Cirrhosis Awaiting Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QOLT
Quality of Life Therapy (QOLT) 8 weekly individual counseling sessions.
Behavioral: Quality of Life Therapy
8 weekly individual counseling sessions
Active Comparator: ST
Supportive Therapy (ST) 8 weekly individual counseling sessions
Behavioral: Supportive Therapy
8 weekly individual counseling sessions
No Intervention: Standard Care

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

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794911

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: James R Rodrigue, Ph.D. Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: James R. Rodrigue, PhD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00794911     History of Changes
Obsolete Identifiers: NCT00794937
Other Study ID Numbers: 2007P-000171
Study First Received: November 19, 2008
Last Updated: March 9, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Liver Transplantation
Quality of Life
Chronic HCV
Hepatitis C Virus
Cirrhosis
Liver disease

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014