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

Primary Purpose

Carcinoma, Hepatocellular

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Palliative Care/Symptom Control
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carcinoma, Hepatocellular focused on measuring Liver Cancer, Randomized Control Trial, Palliative Care, Liver Cell Carcinoma, Palliative Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lyndon Baines Johnson (LBJ) General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Therapy

Early Palliative Care/Symptom Control

Arm Description

Patients will undergo standard medical care for Hepatocellular Carcinoma diagnosis.Patients however will not be denied early palliative care if requested.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Survival
Overall Survival. The investigators will assess if the intervention improves overall survival. The unit of measure will be months
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.
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.

Full Information

First Posted
September 10, 2015
Last Updated
April 26, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02556619
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Liver Cancer, Randomized Control Trial, Palliative Care, Liver Cell Carcinoma, Palliative Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Therapy
Arm Type
No Intervention
Arm Description
Patients will undergo standard medical care for Hepatocellular Carcinoma diagnosis.Patients however will not be denied early palliative care if requested.
Arm Title
Early Palliative Care/Symptom Control
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Early Palliative Care/Symptom Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Health-Related Quality of Life (HRQoL)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Survival
Description
Overall Survival. The investigators will assess if the intervention improves overall survival. The unit of measure will be months
Time Frame
2 Years after diagnosis
Title
Resource Utilization
Description
The investigators will determine if the intervention decreases resource utilization (ICU days and length of stay). The unit of measure will be days.
Time Frame
2 Years after diagnosis
Title
Cost Utilization
Description
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.
Time Frame
2 Years after diagnosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Curtis J Wray, MD
Phone
713-566-5095
Email
Curtis.J.Wray@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Debbie F Lew, MPH
Phone
713-566-5097
Email
Debbie.F.Lew@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis J Wray, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon Baines Johnson (LBJ) General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Curtis J Wray, MD
Phone
713-566-5098
Email
Curtis.J.Wray@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Debbie F Lew, MPH
Phone
713-566-5097
Email
Debbie.F.Lew@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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