Early Palliative Care Integration in Interventional Cancer Care

NCT03185416 | Withdrawn

• 1 other identifier: 20161049
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Palliative Care; Cancer Liver; Cancer Colon

Keywords

Quality of Life; Caregiver; Quality Improvement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure of the Eastern Cooperative Oncology Group (ECOG) performance Status

  1, 2 and 3 months

Other Outcomes (5)

• Caregiver Well-being Scale

  1, 2 and 3 months

• Caregiver Quality of Life-Cancer Scale

  1, 2 and 3 months

• Measure the decrease in the score of the Center for Epidemiologic Studies Depression Scale (CES-D).

  1, 2 and 3 months

Study Arms (2)

Control group

NO INTERVENTION

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

EXPERIMENTAL

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.

Other: Palliative Care Training

Interventions

Palliative Care Training 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.

Also known as: Counseling

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients over 18 years of age with a confirmed diagnosis of liver cancer or metastatic colorectal cancer requiring treatment from the IR team.

You may not qualify if:

• \- None

Sponsors & Collaborators

• University of Miami: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Colonic Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ana M Echenique, MD

  Univeristy of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical, Vascular Interventional

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

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: June 14, 2017
• Study Start: August 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: April 9, 2018

Record last verified: 2018-04