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

Carcinoma, Hepatocellular Clinical Trial

Official title:

Early Symptom Control and Palliative Care Referral for Advanced Hepatocellular Carcinoma; a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02556619
• Other study ID #: HSC-MS-15-0559
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: September 2021

Study information

• Verified date: April 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: Curtis J Wray, MD
• Phone: 713-566-5095
• Email: Curtis.J.Wray[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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.

Locations

Country	Name	City	State
United States	Lyndon Baines Johnson (LBJ) General Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Health-Related Quality of Life (HRQoL)	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.	6 months
Secondary	Survival	Overall Survival. The investigators will assess if the intervention improves overall survival. The unit of measure will be months	2 Years after diagnosis
Secondary	Resource Utilization	The investigators will determine if the intervention decreases resource utilization (ICU days and length of stay). The unit of measure will be days.	2 Years after diagnosis
Secondary	Cost Utilization	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.	2 Years after diagnosis