Recruiting

Early Palliative Care

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT02556619

Conditions

Carcinoma, Hepatocellular

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early Palliative Care/Symptom Control

Study Details

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.

Conditions

Carcinoma, Hepatocellular

Study ID

NCT02556619

Start date

Apr 2, 2019

Status verified date

Apr, 2021

Completion date

Sep, 2021

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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:

1. Establish palliative care goals
2. Symptom Assessment and Control
3. End-of-Life Care

Interventions

Early 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.

Primary outcome measure

  • Change in Health-Related Quality of Life (HRQoL) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Curtis J Wray, MD

713-566-5095Curtis.J.Wray@uth.tmc.edu

Debbie F Lew, MPH

713-566-5097Debbie.F.Lew@uth.tmc.edu

Locations

Lyndon Baines Johnson (LBJ) General Hospital

Recruiting

Houston, Texas, United States, 77026

Contacts

Curtis J Wray, MD

713-566-5098Curtis.J.Wray@uth.tmc.edu

Debbie F Lew, MPH

713-566-5097Debbie.F.Lew@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Apr 27, 2021

Last verified

Apr, 2021

Keywords

  • Liver Cancer
  • Randomized Control Trial
  • Palliative Care
  • Liver Cell Carcinoma
  • Palliative Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2021-04-27.