← Back to Search

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

No Placebo-Only Group

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in zbi-12 scores from baseline to 3 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Life (QOL)

Secondary study objectives

Caregiver burden

Patient Satisfaction

Patient's depression severity

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 1Eligibility criteria met