Early Palliative Care Intervention in Malignant Glioma

Model of Early Palliative Care Intervention in Patients With Newly Diagnosed WHO Grade IV Malignant Glioma, a Single Arm Feasibility Study

The purpose of this research study is to determine the feasibility and acceptability of incorporating palliative care into the clinical care plans of patients newly diagnosed with malignant brain tumors. Palliative Care is a field of medicine that focuses on providing relief from symptoms and stress related to serious illnesses. This study will assess the feasibility of conducting a future study, and will gather data upon which to appropriately tailor the intervention and the future study design. The statistical analysis of this study will describe 8 components that encompass each of the 4 areas of focus or "domains": acceptability, demand, implementation, and integration.

Study Overview

• Status: Completed
• Conditions: Malignant Glioma
• Intervention / Treatment: Behavioral: Palliative Care

Detailed Description

Patients who agree to participate at their initial consultation in our clinic will receive a referral to a Palliative Care (PC) provider who is also located in our clinic and an initial appointment will be scheduled with the PC provider. The frequency of follow-up visits with the PC provider will be at the discretion of the PC provider and the patient. Visits with the PC and neuro-oncology providers will be scheduled on the same day whenever possible. As part of the study, participants will be asked to complete a number of questionnaires and assessment forms at different time intervals. These questionnaires and assessments are intended to track symptoms experienced during the course of treatment. Total study duration is about nine months.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • The Preston Robert Tisch Brain Tumor Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥ 18 years of age
• Patient must have histologically confirmed, newly diagnosed WHO grade IV malignant glioma (confirmation from biopsy, sub-total, or gross-total resection)
• Tumor must be de novo grade IV malignant glioma (i.e. NOT transformed from a lower grade)
• Patient should be planning to receive standard chemoradiation (3 or 6 week protocols are acceptable)
• Treating neuro-oncologist agrees to the patient's participation in this clinical trial
• Patient should be able to read and write English

Exclusion Criteria:

• Patient who currently has a PC provider and/or is receiving hospice care or plans on initiating hospice at the time of enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Palliative care; Newly diagnosed patients will be referred to a palliative care provider in the clinic for initial consultation and follow-up during their initial treatment for WHO Grade IV malignant glioma. Patients will be asked to complete a number of questionnaires and assessment forms at different time intervals during the course of their initial treatment. In addition, we will ask patients' neuro-oncology providers for feedback regarding their satisfaction with the Palliative Care services provided to the patient.

Behavioral: Palliative Care; Initial consultation and follow-up with a palliative care provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability: Patient satisfaction	Mean scores obtained from patient-completed FAMCARE-P16 questionnaires. The FAMCARE-P16 measures patient satisfaction using 16 items on a Likert scale which are summed together to produce an aggregate score of satisfaction. It will be administered at study completion or when a patient is discharged to hospice or withdraws study participation.	8 months
Acceptability: Provider satisfaction	The percentage of providers who respond "Always" or "Most of the time" to the question "Were you satisfied with your patient's care are the palliative care clinic?" among those providers who complete the Palliative Care Clinic (PCC) Referring Provider Satisfaction Survey upon each patient's study completion.	8 months
Acceptability: Continuation of follow-up with palliative care provider after initial consultation	The percentage of patients who continue to follow up with their palliative care provider after initial consultation among those who receive initial consultation.	8 months
Acceptability: Continuation of follow-up with palliative care provider beyond study period	The percentage of patients who respond "Yes" to the question "Do you plan to continue to see a palliative care provider after your participation on the study is complete?" among those who complete the end of study questionnaires. This question will be included in the questionnaires administered at study completion.	8 months
Demand: Time to enroll 50 patients	The difference in months between the date the first patient is enrolled and the date the 50th patient is enrolled.	2 years
Demand: Enrollment percentage	The percentage of patients who choose to enroll in the study among those to which the study is offered.	2 years
Implementation: Study completion percentage	The percentage of patients who complete all study-related questionnaires and procedures among those enrolled.	2 years
Integration: Provider perception of feasibility	The percentage of providers who respond "Yes" or "Yes with modification" to the question "Do you think that this model of early palliative care referral is feasible to integrate into the existing clinical infrastructure in your outpatient oncology clinic?" among those providers who complete the PCC Referring Provider Satisfaction Survey upon each patient's study completion.	2 years

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Duke Cancer Institute
• Investigators: Principal Investigator: Katherine Peters, MD, PhD, The Preston Robert Tisch Brain Tumor Center; Principal Investigator: David Casarett, MD, MA, Palliative Care

Publications and helpful links

Helpful Links

• The Preston Robert Tisch Brain Tumor Center at Duke
• Study Results

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2018
• Primary Completion (Actual): June 17, 2019
• Study Completion (Actual): June 17, 2019

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Palliative Care; Malignant Glioma; Katherine Peters; Pro00091481; David Casarett
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: Pro00091481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No