Early Palliative Care Integration in Interventional Cancer Care

Palliative Care Clinical Trial

— EPIICC  

Official title:

Early Palliative Care Integration in Interventional Cancer Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03185416
• Other study ID #: 20161049
• Status: Withdrawn
• Phase: N/A
• First received: April 27, 2017
• Last updated: April 5, 2018
• Start date: August 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: April 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Colon
• Cancer Liver
• Palliative Care

Intervention

Other:
• Palliative Care Training
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver Well-being Scale	The caregiver well-being Scale will measure the Caregiver Well-Being.	1, 2 and 3 months
Other	Caregiver Quality of Life-Cancer Scale	The caregiver Quality of Life-Cancer Scale will measure the quality of life of subjects with cancer.	1, 2 and 3 months
Other	Measure the decrease in the score of the Center for Epidemiologic Studies Depression Scale (CES-D).	It is anticipated that the CES-D score will be decreased from baseline as a result of the proposed intervention.	1, 2 and 3 months
Other	Health services utilization	Subsequent to the integration of palliative care resulting in improved patient outcomes, the frequency of ED visits, ICU visits, and hospital stays will decrease.	1, 2 and 3 months
Other	Health services costs	Subsequent to the integration of palliative care resulting in improved patient outcomes, the frequency of ED visits, ICU visits, and hospital stays will decrease and therefore reduce costs.	1, 2 and 3 months
Primary	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.	1, 2 and 3 months
Secondary	Measure of the Eastern Cooperative Oncology Group (ECOG) performance Status	Measure the decrease of the ECOG status as a result of the proposed intervention.	1, 2 and 3 months