Clinical trial NCT02556619: Randomized Control Trial (RCT) of Early Palliative Care for HCC
Official title: Early Symptom Control and Palliative Care Referral for Advanced Hepatocellular Carcinoma; a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Liver Cancer
Randomized Control Trial
Palliative Care
Liver Cell Carcinoma
Palliative Therapy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2015-09-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Health-Related Quality of Life (HRQoL)
timeFrame: 6 months
Secondary outcomes:
measure: Survival
timeFrame: 2 Years after diagnosis
measure: Resource Utilization
timeFrame: 2 Years after diagnosis
measure: Cost Utilization
timeFrame: 2 Years after diagnosis
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon Baines Johnson (LBJ) General Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Curtis J Wray, MD
role: PRINCIPAL_INVESTIGATOR
References: