Randomized Control Trial (RCT) of Early Palliative Care for HCC

The University of Texas System (UT)

Status: Unknown

Conditions: Carcinoma, Hepatocellular

Treatments: Behavioral: Early Palliative Care/Symptom Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02556619

HSC-MS-15-0559

Details and patient eligibility

About

The purpose of this research study is to evaluate the effect of early palliative care consultation on quality of life, use of hospital resources, end-of-life care and survival among Hepatocellular Carcinoma (HCC) patients with advanced End Stage Live Disease not eligible for potentially curative or local area therapy. Half of patients will receive early palliative care at diagnosis of HCC and other half will receive palliative care when all standard therapy treatments have been exhausted.

Full description

Intro:

Hypothesis Methods Analysis Anticipated Results

Palliative care will focus on providing relief from the symptoms and stress associated from cancer. This helps improve quality of life for cancer patients and their family. This care is usually offered to patients when all standard therapy treatments have been exhausted.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed HCC by biopsy or liver protocol CT scan or MRI characteristics
• Permanent street address with Harris County, Texas and consent to study participation
• English or Spanish speaking with ability to respond to the QoL questionnaires
• Child-Pugh C, not eligible for liver transplantation (TXP), surgical resection, ablation, locoregional or systemic therapy
• Child-Pugh C, eligible for systemic chemotherapy (Sorafenib), not eligible for TXP, surgical resection, ablation or locoregional therapy
• Child-Pugh A or B, not eligible for surgical resection or ablation (>3 lesions or 2 lesions with one being >5cm)
• Child-Pugh A, not eligible for TXP, surgical resection, ablation or locoregional therapy

Exclusion criteria

• Primary modality of treatment is potentially curative TXP, surgical resection or ablation as deemed by GI MDC
• Child-Pugh A or B (up to 2 lesions < 5cm in size)
• Medical (e.g. severe encephalopathy), psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• Any medical condition (acute myocardial infarction or stroke) that could jeopardize the safety of the patient and his/her compliance in the study
• Vulnerable population (inmates in jail or prison)
• Non-English or Non-Spanish Speaking patients.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Standard Therapy

No Intervention group

Description:

Patients will undergo standard medical care for Hepatocellular Carcinoma diagnosis.Patients however will not be denied early palliative care if requested.

Early Palliative Care/Symptom Control

Experimental group

Description:

Patients will undergo palliative care services at time of Hepatocellular Carcinoma diagnosis. Palliative care and symptom control services are adapted from the National Consensus Project for Quality Palliative Care. Early referral, patients meeting inclusion criteria will be enrolled and referred to palliative care within 3 weeks of the index consultation with Medical-Oncology, Surgical-Oncology or Gastroenterology. Intervention will be: 1. Establish palliative care goals 2. Symptom Assessment and Control 3. End-of-Life Care

Treatment:

Behavioral: Early Palliative Care/Symptom Control