Quality of Life Therapy for Adults With Hepatitis C Virus and Cirrhosis Awaiting Liver Transplantation
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 19, 2008
CompletedFirst Posted
Study publicly available on registry
November 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 15, 2017
March 1, 2011
3.3 years
November 19, 2008
March 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Study Arms (3)
QOLT
EXPERIMENTALQuality of Life Therapy (QOLT) 8 weekly individual counseling sessions.
ST
ACTIVE COMPARATORSupportive Therapy (ST) 8 weekly individual counseling sessions
Standard Care
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James R Rodrigue, Ph.D.
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychology in the Department of Psychiatry
Study Record Dates
First Submitted
November 19, 2008
First Posted
November 20, 2008
Study Start
September 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 15, 2017
Record last verified: 2011-03