Palliative CareEPIICCNCT03185416
Early Palliative Care Integration in Interventional Cancer Care
A study testing Palliative Care Training in people with Palliative Care and Cancer Liver, run by University of Miami.
Trial summary
A mixed methods randomized control trial assessing the impact of early palliative care incorporation in liver cancer and metastatic colorectal cancer on caregiver well-being, patient physical and psychosocial outcomes, and health services utilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Cancer Liver, Cancer Colon
- What is being tested?
- Palliative Care Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Aug 2019
- 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
- Patients over 18 years of age with a confirmed diagnosis of liver cancer or metastatic colorectal cancer requiring treatment from the IR team.
Who cannot join
- None
About this study
A mixed methods randomized control trial assessing the impact of early palliative care incorporation in liver cancer and metastatic colorectal cancer on caregiver well-being, patient physical and psychosocial outcomes, and health services utilization.
Read the detailed description
The purpose of this project is to conduct a mixed-methods study of the impact of early integration of palliative care in interventional oncology on three outcomes of interest:
- caregiver well-being, 2) patient physical and psychosocial outcomes, and 3) health services utilization and costs. Palliative care focuses on providing patients with serious illnesses and their families with physical, emotional, social, practical, and spiritual support. Recent trials examining the integration of palliative care in cancer care have individually shown improvement in patient symptoms and quality of life, reduction of caregiver burden, and/or health services costs. These studies, however, have not collectively analyzed these impacts.Further, a recent study shows that integrating palliative care early in lung cancer care has proven beneficial to both patients and caregivers. Given the potential of this previous body of research, the proposed study offers a comprehensive analysis of the early integration of palliative care on caregiver well-being, patient's physical and psychosocial outcomes when living with liver and metastatic colorectal cancer (mCRC), and health services utilization. This study thus broadens the scope to additional cancer types and degrees of progression.
- Conditions
- Palliative Care, Cancer Liver, Cancer Colon
- Being tested
- Palliative Care Training
- Keywords
- Quality of Life, Caregiver, Quality Improvement
- Medical subject headings
- Carcinoma, Hepatocellular, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Care TrainingOther
Also called Counseling
The intervention group- will include 30 patients receiving treatment by the Interventional Radiology team along with their primary caregiver. Patients and caregivers will receive a brief palliative care training intervention during their first follow-up visit. Patients and their caregivers will receive questionnaires to assess their health status (physical and psychosocial) and health services utilization outcomes at 1, 2, and 3 months post-procedure during their follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The first prospective group -the control group- will consist of 30 patients receiving treatment by the Interventional Radiology team- along with their 30 primary caregivers. Neither the patient nor the caregiver will receive the palliative care training intervention. Patients and their caregivers will receive questionnaires regarding their health status (physical and psychosocial) and health services utilization at 1, 2, and 3 months post-procedure- during their follow-up visits. |
| Intervention Group | Experimental | The second prospective component of the study -the intervention group- will include 30 patients receiving treatment by the Interventional Radiology team along with their primary caregiver. Patients and caregivers will receive a brief palliative care training intervention during their first follow-up visit. Patients and their caregivers will receive questionnaires to assess their health status (physical and psychosocial) and health services utilization outcomes at 1, 2, and 3 months post-procedure during their follow-up visits. Receives: Other: Palliative Care Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Edmonton Symptom Assessment Score (ESAS-R)
Measure the impact of an early palliative care intervention on patient physical and psychosocial outcomes. The early integration of palliative care at diagnosis or immediately post- procedure, will improve patients' physical and psychosocial symptoms. The score of such assessment should decrease from baseline as the result of the intervention.
Measured: 1, 2 and 3 months
Secondary outcomes (1)
Measure of the Eastern Cooperative Oncology Group (ECOG) performance Status
Measure the decrease of the ECOG status as a result of the proposed intervention.
Measured: 1, 2 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Aug 2018 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Why it stopped: PI leaving University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is a randomized single-center therapeutic clinical trial including the following two prospective groups: Control group and the intervention group.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana M. Echenique, University of Miami
- Investigators
- Ana M Echenique, MD, Principal investigator, Univeristy of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185416
- Sponsor's protocol ID
- 20161049
- Acronym
- EPIICC
- Status last verified
- Apr 2018
- First submitted
- 27 Apr 2017
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There are no plans to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Palliative Care Integration in Interventional Cancer Care
- ClinicalTrials.gov ID
- NCT03185416
- Acronym / sponsor ID
- EPIICC / 20161049
- Conditions
- Palliative Care, Cancer Liver, Cancer Colon
- Keywords
- Quality of Life, Caregiver, Quality Improvement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 14 Jun 2017 (actual)
- 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.
A mixed methods randomized control trial assessing the impact of early palliative care incorporation in liver cancer and metastatic colorectal cancer on caregiver well-being, patient physical and psychosocial outcomes, and health services utilization.
Detailed description
The purpose of this project is to conduct a mixed-methods study of the impact of early integration of palliative care in interventional oncology on three outcomes of interest:
- caregiver well-being, 2) patient physical and psychosocial outcomes, and 3) health services utilization and costs. Palliative care focuses on providing patients with serious illnesses and their families with physical, emotional, social, practical, and spiritual support. Recent trials examining the integration of palliative care in cancer care have individually shown improvement in patient symptoms and quality of life, reduction of caregiver burden, and/or health services costs. These studies, however, have not collectively analyzed these impacts.Further, a recent study shows that integrating palliative care early in lung cancer care has proven beneficial to both patients and caregivers. Given the potential of this previous body of research, the proposed study offers a comprehensive analysis of the early integration of palliative care on caregiver well-being, patient's physical and psychosocial outcomes when living with liver and metastatic colorectal cancer (mCRC), and health services utilization. This study thus broadens the scope to additional cancer types and degrees of progression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study is a randomized single-center therapeutic clinical trial including the following two prospective groups: Control group and the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The first prospective group -the control group- will consist of 30 patients receiving treatment by the Interventional Radiology team- along with their 30 primary caregivers. Neither the patient nor the caregiver will receive the palliative care training intervention. Patients and their caregivers will receive questionnaires regarding their health status (physical and psychosocial) and health services utilization at 1, 2, and 3 months post-procedure- during their follow-up visits. |
| Intervention Group | Experimental | Other: Palliative Care TrainingThe second prospective component of the study -the intervention group- will include 30 patients receiving treatment by the Interventional Radiology team along with their primary caregiver. Patients and caregivers will receive a brief palliative care training intervention during their first follow-up visit. Patients and their caregivers will receive questionnaires to assess their health status (physical and psychosocial) and health services utilization outcomes at 1, 2, and 3 months post-procedure during their follow-up visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age with a confirmed diagnosis of liver cancer or metastatic colorectal cancer requiring treatment from the IR team.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Palliative Care TrainingAlso: CounselingThe intervention group- will include 30 patients receiving treatment by the Interventional Radiology team along with their primary caregiver. Patients and caregivers will receive a brief palliative care training intervention during their first follow-up visit. Patients and their caregivers will receive questionnaires to assess their health status (physical and psychosocial) and health services utilization outcomes at 1, 2, and 3 months post-procedure during their follow-up visits. | Other | Intervention Group |
Primary outcome
Changes in Edmonton Symptom Assessment Score (ESAS-R)
Time frame: 1, 2 and 3 months
Measure the impact of an early palliative care intervention on patient physical and psychosocial outcomes. The early integration of palliative care at diagnosis or immediately post- procedure, will improve patients' physical and psychosocial symptoms. The score of such assessment should decrease from baseline as the result of the intervention.
1 secondary outcome
Measure of the Eastern Cooperative Oncology Group (ECOG) performance Status
Time frame: 1, 2 and 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Individual participant dataSharing planned: Undecided. There are no plans to share IPD with other researchers.
Related trials for Palliative Care
Active, not recruitingPhase 2
Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers
Metastatic Malignant Female Reproductive System Neoplasm
Enrolling by invitationPhase 3
Nudging Effective and Equitable Delivery of Specialty Palliative Care
Serious Illness, Palliative
Not yet recruiting
Integrating Rhythmical Massage in Palliative Care
Palliative Care, Health Services, Palliative Care
Not yet recruitingPhase 1/2
Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
Intractable Pain, Palliative Care
RecruitingPhase 2
Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma
Peritoneal Malignant Mesothelioma
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.
Ana M Echenique, MD principal investigator
Univeristy of Miami
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care Training in people with Palliative Care and Cancer Liver, run by University of Miami.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Edmonton Symptom Assessment Score (ESAS-R) (time frame: 1, 2 and 3 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 9 Apr 2018.