Randomized Control Trial (RCT) of Early Palliative Care for HCC

NCT ID: NCT02556619

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2021-09-30

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.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard Therapy

Patients will undergo standard medical care for Hepatocellular Carcinoma diagnosis.Patients however will not be denied early palliative care if requested.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Early Palliative Care/Symptom Control

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Curtis Jackson Wray

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Curtis J Wray, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Lyndon Baines Johnson (LBJ) General Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Curtis J Wray, MD

Role: CONTACT

Curtis.J.Wray@uth.tmc.edu

713-566-5095

Debbie F Lew, MPH

Role: CONTACT

Debbie.F.Lew@uth.tmc.edu

713-566-5097

Facility Contacts

Curtis J Wray, MD

Role: primary

Curtis.J.Wray@uth.tmc.edu

713-566-5098

Debbie F Lew, MPH

Role: backup

Debbie.F.Lew@uth.tmc.edu

713-566-5097

Other Identifiers

HSC-MS-15-0559

Identifier Type: -

Identifier Source: org_study_id