Carcinoma, HepatocellularNCT02556619
Randomized Control Trial (RCT) of Early Palliative Care for HCC
A study of Carcinoma, Hepatocellular, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lyndon Baines Johnson (LBJ) General Hospital
Houston, Texas, 77026
Curtis J Wray, MD, 713-566-5098, Curtis.J.Wray@uth.tmc.edu
Debbie F Lew, MPH, 713-566-5097, Debbie.F.Lew@uth.tmc.edu
About this study
Official title: Early Symptom Control and Palliative Care Referral for Advanced Hepatocellular Carcinoma; a Randomized Control Trial
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.
Read the 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
- Being tested
- Early Palliative Care/Symptom Control
- Keywords
- Liver Cancer, Randomized Control Trial, Palliative Care, Liver Cell Carcinoma, Palliative Therapy
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Palliative Care/Symptom ControlBehavioural
- Establish palliative care goals
- Determination of Medical Power of Attorney
- Discuss/plan code status/advance directives
- Document palliative care goals
- Symptom Assessment and Control
- Pain-treatment with opioid and non-opioid medications
- Itching-H2 blockers, steroids
- Nutrition-appetite stimulated with Megace, review low sodium diet
- Ascites/edema- optimize ascites management with Lasix or Aldactone. In refractory cases intermittent paracentesis can be performed
- Nausea- treated with anti-emetics
- Jaundice and Body Image- counselling regarding symptoms
- End-of-Life Care
- Discuss religious preferences
- Assess for distress- ensure interaction with Cancer Resource Center
- Hospice- charity Hospice options for select patients.
| Study group | Role | What they receive |
|---|---|---|
| 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:
1. Establish palliative care goals
2. Symptom Assessment and Control
3. End-of-Life Care Receives: Behavioral: Early Palliative Care/Symptom Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Survival
Overall Survival. The investigators will assess if the intervention improves overall survival. The unit of measure will be months
Measured: 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.
Measured: 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.
Measured: 2 Years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start2 Apr 2019
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Curtis Jackson Wray, The University of Texas Health Science Center, Houston
- Investigators
- Curtis J Wray, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556619
- Sponsor's protocol ID
- HSC-MS-15-0559
- Status last verified
- Apr 2021
- First submitted
- 10 Sep 2015
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Symptom Control and Palliative Care Referral for Advanced Hepatocellular Carcinoma; a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02556619
- Acronym / sponsor ID
- HSC-MS-15-0559
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Liver Cancer, Randomized Control Trial, Palliative Care, Liver Cell Carcinoma, Palliative Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Early Palliative Care/Symptom ControlPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Palliative Care/Symptom Control1. 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. | Behavioural | Early Palliative Care/Symptom Control |
Primary outcome
Change in Health-Related Quality of Life (HRQoL)
Time frame: 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.
3 secondary outcomes
Survival
Time frame: 2 Years after diagnosis
Resource Utilization
Time frame: 2 Years after diagnosis
Cost Utilization
Time frame: 2 Years after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curtis J Wray, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Carcinoma, Hepatocellular, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Curtis J Wray, MD (713-566-5095, Curtis.J.Wray@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health-Related Quality of Life (HRQoL) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.