Randomized Control Trial (RCT) of Early Palliative Care for HCC
Purpose
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.
Condition
- Carcinoma, Hepatocellular
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
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. |
|
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: Establish palliative care goals Symptom Assessment and Control End-of-Life Care |
|
Recruiting Locations
Houston, Texas 77026
More Details
- Status
- Unknown status
- Sponsor
- The University of Texas Health Science Center, Houston
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.