Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Standard Therapy
Patients will undergo standard medical care for Hepatocellular Carcinoma diagnosis.Patients however will not be denied early palliative care if requested.
Experimental
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: Establish palliative care goals Symptom Assessment and Control End-of-Life Care
  • Behavioral: Early Palliative Care/Symptom Control
    Establish palliative care goals Determination of Medical Power of Attorney Discuss/plan code status/advance directives Document palliative care goals Symptom Assessment and Control Pain-treatment with opioid and non-opioid medications Itching-H2 blockers, steroids Nutrition-appetite stimulated with Megace, review low sodium diet Ascites/edema- optimize ascites management with Lasix or Aldactone. In refractory cases intermittent paracentesis can be performed Nausea- treated with anti-emetics Jaundice and Body Image- counselling regarding symptoms End-of-Life Care Discuss religious preferences Assess for distress- ensure interaction with Cancer Resource Center Hospice- charity Hospice options for select patients.

Recruiting Locations

Lyndon Baines Johnson (LBJ) General Hospital
Houston, Texas 77026
Contact:
Curtis J Wray, MD
713-566-5098
Curtis.J.Wray@uth.tmc.edu

More Details

Status
Unknown status
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Curtis J Wray, MD
713-566-5095
Curtis.J.Wray@uth.tmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.