Early Symptom Control and Palliative Care Referral for Advanced Hepatocellular Carcinoma; a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in Health-Related Quality of Life (HRQoL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in Health-Related Quality of Life (HRQoL)
时间窗: 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.
次要结局
- Survival(2 Years after diagnosis)
- Resource Utilization(2 Years after diagnosis)
- Cost Utilization(2 Years after diagnosis)
研究者
Curtis Jackson Wray
Associate Professor
The University of Texas Health Science Center, Houston