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

NCT02556619 | Unknown

• 1 other identifier: HSC-MS-15-0559
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Liver Cancer; Randomized Control Trial; Palliative Care; Liver Cell Carcinoma; Palliative Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Survival

  2 Years after diagnosis

• Resource Utilization

  2 Years after diagnosis

• Cost Utilization

  2 Years after diagnosis

Study Arms (2)

Standard Therapy

NO INTERVENTION

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

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

Behavioral: Early Palliative Care/Symptom Control

Interventions

Early Palliative Care/Symptom Control BEHAVIORAL

1. Establish palliative care goals 1. Determination of Medical Power of Attorney 2. Discuss/plan code status/advance directives 3. Document palliative care goals 2. Symptom Assessment and Control 1. Pain-treatment with opioid and non-opioid medications 2. Itching-H2 blockers, steroids 3. Nutrition-appetite stimulated with Megace, review low sodium diet 4. Ascites/edema- optimize ascites management with Lasix or Aldactone. In refractory cases intermittent paracentesis can be performed 5. Nausea- treated with anti-emetics 6. Jaundice and Body Image- counselling regarding symptoms 3. End-of-Life Care 1. Discuss religious preferences 2. Assess for distress- ensure interaction with Cancer Resource Center 3. Hospice- charity Hospice options for select patients.

Early Palliative Care/Symptom Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Lyndon Baines Johnson (LBJ) General Hospital

Houston, Texas, 77026, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Curtis J Wray, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Curtis J Wray, MD

CONTACT

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

Debbie F Lew, MPH

CONTACT

713-566-5097; Debbie.F.Lew@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 22, 2015
• Study Start: April 2, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)