Randomized Control Trial (RCT) of Early Palliative Care for HCC (NCT02556619) | Clinical Trial Compass
UnknownNot Applicable
Randomized Control Trial (RCT) of Early Palliative Care for HCC
United States72 participantsStarted 2019-04-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Change in Health-Related Quality of Life (HRQoL)
Timeframe: 6 months
Trial details
NCT IDNCT02556619
SponsorThe University of Texas Health Science Center, Houston