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Palliative Care for End Stage Liver Disease (PAL-LIVER Trial)

N/A
Recruiting
Led By Manisha Verma, MBBS, MPH
Research Sponsored by Albert Einstein Healthcare Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with new onset or ongoing complications of End Stage Liver Disease including Hepatocellular Cancer (HCC) (irrespective of their transplant status), with a caregiver willing to participate.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in zbi-12 scores from baseline to 3 months
Awards & highlights

PAL-LIVER Trial Summary

This trial is comparing two ways of introducing palliative care for people with end stage liver disease - either by having direct access to a palliative care provider, or by training a hepatologist to deliver palliative care services. The primary outcome is the change in quality of life from baseline to 3 months post enrollment, as assessed by the Functional Assessment of Cancer Therapy- Hepatobiliary. 14 Clinical Centers across the US are recruited to participate in this study.

Who is the study for?
This trial is for patients with new or ongoing complications of End Stage Liver Disease, including liver cancer, regardless of their transplant status. They must have a caregiver willing to participate. It's not for those with a MELD score over 30 or an expected life expectancy under 6 months.Check my eligibility
What is being tested?
The study compares two ways to provide palliative care: one where patients see a specialist and another where liver doctors are trained in palliative care. The main goal is to see how these approaches affect quality of life after three months using the FACT-Hep scale.See study design
What are the potential side effects?
Since this trial focuses on palliative care rather than medication, side effects aren't the primary concern; however, any changes in comfort levels or potential stress from different models of care will be monitored.

PAL-LIVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have advanced liver disease or liver cancer and have a caregiver willing to participate.

PAL-LIVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in zbi-12 scores from baseline to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in zbi-12 scores from baseline to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quality of Life (QOL)
Secondary outcome measures
Caregiver burden
Patient Satisfaction
Patient's depression severity
+1 more

PAL-LIVER Trial Design

2Treatment groups
Active Control
Group I: Model 1: Consultative Palliative CareActive Control1 Intervention
Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist.
Group II: Model 2: Trained Hepatologist- led PCActive Control1 Intervention
A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1

Find a Location

Who is running the clinical trial?

Albert Einstein Healthcare NetworkLead Sponsor
63 Previous Clinical Trials
867,362 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
548 Previous Clinical Trials
29,995,128 Total Patients Enrolled
Manisha Verma, MBBS, MPHPrincipal InvestigatorAlbert Einstein Healthcare Network
1 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Palliative Care Clinical Trial Eligibility Overview. Trial Name: NCT03540771 — N/A
Liver Disease Research Study Groups: Model 1: Consultative Palliative Care, Model 2: Trained Hepatologist- led PC
Liver Disease Clinical Trial 2023: Palliative Care Highlights & Side Effects. Trial Name: NCT03540771 — N/A
Palliative Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT03540771 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction for this medical trial limited to those younger than 45 years of age?

"As per the requirements for this medical trial, eligible candidates must be aged between 18 and 120."

Answered by AI

How many sites are responsible for overseeing this clinical experiment?

"Loma Linda Unversity Health, Kansas City VA Medical Center and Medical University of South carolina are only a few of the 18 medical centres currently running this trial."

Answered by AI

Is it possible to enroll in this trial at present?

"This clinical trial is attempting to recruit 1260 individuals suffering from chronic liver failure, aged between 18 and 120. Candidates must meet a few prerequisite criteria including being diagnosed with End Stage Liver Disease or Hepatocellular Cancer (no matter their transplant status) as well as having an accompanying caregiver that can be involved in the study."

Answered by AI

Is recruitment still taking place for this research initiative?

"Affirmative. The information on clinicaltrials.gov confirms the recruitment status of this study, which was originally posted in January 2019 and last updated in April 2022. It requires 1260 volunteers from 18 different medical institutes to participate."

Answered by AI

How many participants are being treated in this medical trial?

"Affirmative. According to clinicaltrials.gov, this research is actively seeking participants with an initial posting date of 1/30/2019 and a recent update on 4/5/2022. 1260 individuals must be recruited from 18 different medical centres for the trial to proceed."

Answered by AI
Recent research and studies
~76 spots leftby Jul 2024