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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Therapy | No Intervention | Patients will undergo standard medical care for Hepatocellular Carcinoma diagnosis.Patients however will not be denied early palliative care if requested. | |
| Early Palliative Care/Symptom Control | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Palliative Care/Symptom Control | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Overall Survival. The investigators will assess if the intervention improves overall survival. The unit of measure will be months | 2 Years after diagnosis |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Curtis J Wray, MD | Contact | 713-566-5095 | Curtis.J.Wray@uth.tmc.edu | |
| Debbie F Lew, MPH | Contact | 713-566-5097 | Debbie.F.Lew@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Curtis J Wray, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon Baines Johnson (LBJ) General Hospital | Recruiting | Houston | Texas | 77026 | United States |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 2 Years after diagnosis |
| 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. | 2 Years after diagnosis |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |