Clinical trial NCT03185416: Early Palliative Care Integration in Interventional Cancer Care
Official title: Early Palliative Care Integration in Interventional Cancer Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Palliative Care
Cancer Liver
Cancer Colon
Keywords: Quality of Life
Caregiver
Quality Improvement
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

- None

Primary outcomes:
measure: Changes in Edmonton Symptom Assessment Score (ESAS-R)
timeFrame: 1, 2 and 3 months
Secondary outcomes:
measure: Measure of the Eastern Cooperative Oncology Group (ECOG) performance Status
timeFrame: 1, 2 and 3 months
Other outcomes:
measure: Caregiver Well-being Scale
timeFrame: 1, 2 and 3 months
measure: Caregiver Quality of Life-Cancer Scale
timeFrame: 1, 2 and 3 months
measure: Measure the decrease in the score of the Center for Epidemiologic Studies Depression Scale (CES-D).
timeFrame: 1, 2 and 3 months
measure: Health services utilization
timeFrame: 1, 2 and 3 months
measure: Health services costs
timeFrame: 1, 2 and 3 months
Locations:
Study officials:
affiliation: Univeristy of Miami
name: Ana M Echenique, MD
role: PRINCIPAL_INVESTIGATOR
References: