Carcinoma, Hepatocellular
Conditions
Keywords
Liver Cancer, Randomized Control Trial, Palliative Care, Liver Cell Carcinoma, Palliative Therapy
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.
Interventions
BEHAVIORALEarly Palliative Care/Symptom Control
1. Establish palliative care goals 1. Determination of Medical Power of Attorney 2. Discuss/plan code status/advance directives 3. Document palliative care goals 2. Symptom Assessment and Control 1. Pain-treatment with opioid and non-opioid medications 2. Itching-H2 blockers, steroids 3. Nutrition-appetite stimulated with Megace, review low sodium diet 4. Ascites/edema- optimize ascites management with Lasix or Aldactone. In refractory cases intermittent paracentesis can be performed 5. Nausea- treated with anti-emetics 6. Jaundice and Body Image- counselling regarding symptoms 3. End-of-Life Care 1. Discuss religious preferences 2. Assess for distress- ensure interaction with Cancer Resource Center 3. Hospice- charity Hospice options for select patients.
Sponsors
American Cancer Society, Inc.
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-Related Quality of Life (HRQoL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 2 Years after diagnosis | Overall Survival. The investigators will assess if the intervention improves overall survival. The unit of measure will be months |
| Resource Utilization | 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. |
| Cost Utilization | 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. |
Countries
United States
Contacts
Primary ContactCurtis J Wray, MD
Backup ContactDebbie F Lew, MPH
Outcome results
None listed