Early Palliative Care Integration in Interventional Cancer Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Miami
- Primary Endpoint
- Changes in Edmonton Symptom Assessment Score (ESAS-R)
Study Overview
Brief 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.
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:
1) 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Patients over 18 years of age with a confirmed diagnosis of liver cancer or metastatic colorectal cancer requiring treatment from the IR team.
Exclusion Criteria
- Not provided
Arms & Interventions
Control group
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
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.
Intervention: Palliative Care Training (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Measure of the Eastern Cooperative Oncology Group (ECOG) performance Status(1, 2 and 3 months)
Investigators
Ana M. Echenique
Associate Professor of Clinical, Vascular Interventional
University of Miami