RECRUITING

LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

Conditions

Liver Disease Chronic End Stage Liver DIsease Cirrhosis Cirrhosis, Liver Advanced Cirrhosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

Official Title

LiverPAL: A Randomized Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

Quick Facts

Study Start:2023-09-20

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05998330

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis with one of the following (new or ongoing) within the prior six months from date of consent: * Ascites (requiring diuretics or serial large volume paracenteses) * Spontaneous bacterial peritonitis * Hepatic hydrothorax (requiring diuretics) * Variceal bleed (with one or more occurrences) * Overt hepatic encephalopathy (requiring medications) 2. Ability to comprehend English	1. Prior history of liver transplantation 2. Have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder or other comorbid condition which the primary medical, hepatology, and/or transplant surgery teams believes prohibits the ability to provide informed consent 3. Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer) 4. Presence of hepatocellular carcinoma beyond Milan criteria 5. Are already receiving hospice care 6. Receive a score of \<10 on the Simplified Animal Naming Test 1. Adult caregiver (≥ 18 years of age) 2. A relative or friend identified by the patient upon whom the patient relies for help and who likely is to be present in-person during hospitalizations or clinic appointments, or willing to participate by phone 3. Ability to comprehend English and can complete questionnaires 1. Inability to comprehend English

Inclusion Criteria

Exclusion Criteria

1. Hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis with one of the following (new or ongoing) within the prior six months from date of consent:
* Ascites (requiring diuretics or serial large volume paracenteses)
* Spontaneous bacterial peritonitis
* Hepatic hydrothorax (requiring diuretics)
* Variceal bleed (with one or more occurrences)
* Overt hepatic encephalopathy (requiring medications)
2. Ability to comprehend English

1. Prior history of liver transplantation
2. Have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder or other comorbid condition which the primary medical, hepatology, and/or transplant surgery teams believes prohibits the ability to provide informed consent
3. Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer)
4. Presence of hepatocellular carcinoma beyond Milan criteria
5. Are already receiving hospice care
6. Receive a score of \<10 on the Simplified Animal Naming Test
1. Adult caregiver (≥ 18 years of age)
2. A relative or friend identified by the patient upon whom the patient relies for help and who likely is to be present in-person during hospitalizations or clinic appointments, or willing to participate by phone
3. Ability to comprehend English and can complete questionnaires
1. Inability to comprehend English

Contacts and Locations

Study Contact

Malia Armstrong, BA

CONTACT

(617)-643-4327

marmstrong6@mgh.harvard.edu

Grace Bizup, BA

CONTACT

617-724-1316

gbizup@mgh.harvard.edu

Principal Investigator

Nneka Ufere, MD MSCE

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Nneka Ufere, MD MSCE, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-20

Study Completion Date2027-07

Study Record Updates

Study Start Date2023-09-20

Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

Liver Disease Chronic
End Stage Liver DIsease
Cirrhosis
Cirrhosis, Liver
Advanced Cirrhosis