Early Palliative Care Integration in Interventional Cancer Care

NCT ID: NCT03185416

Last Updated: 2018-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-08-01

Brief Summary

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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

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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.

Conditions

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Palliative Care Cancer Liver Cancer Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The present study is a randomized single-center therapeutic clinical trial including the following two prospective groups: Control group and the intervention group.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Palliative Care Training

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Counseling

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Ana M. Echenique

Associate Professor of Clinical, Vascular Interventional

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana M Echenique, MD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Miami

Other Identifiers

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20161049

Identifier Type: -

Identifier Source: org_study_id

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