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

Not Applicable

• Conditions: Carcinoma, Hepatocellular
• Interventions: Behavioral: Early Palliative Care/Symptom Control

• Registration Number: NCT02556619
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Study Start: 2019-04-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Palliative Care/Symptom Control	Early Palliative Care/Symptom Control	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

Primary Outcome Measures

Name	Time	Method
Change in Health-Related Quality of Life (HRQoL)	6 months	The primary outcome is the change in the patient's primary need based upon HRQoL survey. These scores range from 0-100 for the role functioning scale, physical function scale and the other QLQ-C30 scales and HCC18 symptom complexes.

Secondary Outcome Measures

Name	Time	Method
Survival	2 Years after diagnosis	Overall Survival. The investigators will assess if the intervention improves overall survival. The unit of measure will be months
Resource Utilization	2 Years after diagnosis	The investigators will determine if the intervention decreases resource utilization (ICU days and length of stay). The unit of measure will be days.
Cost Utilization	2 Years after diagnosis	The investigators will determine if the intervention decreases cost between groups. To do this, the investigators will track cost per group from time of study enrollment to either death, withdrawal or study completion. Cost will be estimated in US dollars.

Trial Locations

Locations (1)

Lyndon Baines Johnson (LBJ) General Hospital; 🇺🇸 Houston, Texas, United States