Randomized Control Trial (RCT) of Early Palliative Care for HCC
April 26, 2021 updated by: Curtis Jackson Wray, The University of Texas Health Science Center, Houston
Early Symptom Control and Palliative Care Referral for Advanced Hepatocellular Carcinoma; a Randomized Control Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Curtis J Wray, MD
- Phone Number: 713-566-5095
- Email: Curtis.J.Wray@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77026
- Recruiting
- Lyndon Baines Johnson (LBJ) General Hospital
-
Contact:
- Curtis J Wray, MD
- Phone Number: 713-566-5098
- Email: Curtis.J.Wray@uth.tmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Health-Related Quality of Life (HRQoL)
Time Frame: 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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival
Time Frame: 2 Years after diagnosis
|
Overall Survival.
The investigators will assess if the intervention improves overall survival.
The unit of measure will be months
|
2 Years after diagnosis
|
|
Resource Utilization
Time Frame: 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.
|
2 Years after diagnosis
|
|
Cost Utilization
Time Frame: 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.
|
2 Years after diagnosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Curtis J Wray, MD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 2, 2019
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
September 1, 2021
Study Registration Dates
First Submitted
September 10, 2015
First Submitted That Met QC Criteria
September 18, 2015
First Posted (Estimate)
September 22, 2015
Study Record Updates
Last Update Posted (Actual)
April 27, 2021
Last Update Submitted That Met QC Criteria
April 26, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-15-0559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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