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Behavioral Intervention
Palliative Care for Advanced Liver Disease (LiverPAL Trial)
N/A
Recruiting
Led By Nneka Ufere, MD MSCE
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
LiverPAL Trial Summary
This trial seeks to help hospitalized patients with AdvLD by integrating palliative care to improve their quality of life, physical symptoms, mood, and communication.
Who is the study for?
This trial is for English-speaking patients hospitalized with advanced liver disease, which includes conditions like overt hepatic encephalopathy (needing medication), ascites (requiring water pills or repeated fluid removal procedures), hepatic hydrothorax (needing water pills), variceal bleeding (one or more episodes), and spontaneous bacterial peritonitis.Check my eligibility
What is being tested?
LiverPAL is being tested to see if starting palliative care early for hospitalized patients with serious liver diseases can help improve their quality of life, ease physical symptoms, better their mood, and enhance communication about their illness.See study design
What are the potential side effects?
Since LiverPAL involves palliative care rather than a drug intervention, side effects are not the typical focus. However, it may involve emotional or psychological impacts as patients discuss and cope with serious illness.
LiverPAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at least 12 months after patient death, up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least 12 months after patient death, up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
Secondary outcome measures
Documentation of Patient End-of-Life (EOL) Care Preferences
Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)
Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)
+5 moreOther outcome measures
Caregiver Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) between study arms.
Caregiver Burden (Zarit Burden Index 12, ZBI-12)
Caregiver Coping (Brief COPE)
+13 moreLiverPAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Hepatology Care with Early Palliative CareExperimental Treatment1 Intervention
Usual hepatology care with early palliative care
Group II: Usual Hepatology CareActive Control1 Intervention
Usual hepatology care
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,441 Total Patients Enrolled
Nneka Ufere, MD MSCEPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a liver transplant in the past.My liver cancer is more advanced than early stage criteria allow.I am currently receiving care focused on my comfort.I have advanced liver disease and was hospitalized for it in the last 6 months.I have an adult caregiver who can be with me during my treatments or join by phone.I have or recently had cancer that is not skin cancer or liver cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Hepatology Care
- Group 2: Usual Hepatology Care with Early Palliative Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the patient recruitment phase of this clinical trial still ongoing?
"As per clinicaltrials.gov, the initial posting for this medical trial was on September 1st 2023 and it has not been recruiting since August 17th of the same year. Fortunately, there are 723 other active studies currently accepting participants at present."
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