Early Palliative Care Integration in Interventional Cancer Care

Not Applicable

Withdrawn

• Conditions: Cancer Liver; Palliative Care; Cancer Colon
• Interventions: Other: Palliative Care Training

• Registration Number: NCT03185416
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-09
• Study Start: 2018-08-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Palliative Care Training	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.

Primary Outcome Measures

Name	Time	Method
Changes in Edmonton Symptom Assessment Score (ESAS-R)	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 Outcome Measures

Name	Time	Method
Measure of the Eastern Cooperative Oncology Group (ECOG) performance Status	1, 2 and 3 months	Measure the decrease of the ECOG status as a result of the proposed intervention.