Clinical trial NCT03471546: Early Palliative Care Intervention in Malignant Glioma
Official title: Model of Early Palliative Care Intervention in Patients With Newly Diagnosed WHO Grade IV Malignant Glioma, a Single Arm Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Glioma
Keywords: Palliative Care
Pro00091481
Malignant Glioma
Katherine Peters
David Casarett
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Cancer Institute
First posted: 2018-03-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients newly diagnosed with World Health Organization (WHO) Grade IV malignant glioma will be referred to a Palliative Care provider in the clinic, in order to assess the impact of early palliative care intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability: Patient satisfaction
timeFrame: 8 months
measure: Acceptability: Provider satisfaction
timeFrame: 8 months
measure: Acceptability: Continuation of follow-up with palliative care provider after initial consultation
timeFrame: 8 months
measure: Acceptability: Continuation of follow-up with palliative care provider beyond study period
timeFrame: 8 months
measure: Demand: Time to enroll 50 patients
timeFrame: 2 years
measure: Demand: Enrollment percentage
timeFrame: 2 years
measure: Implementation: Study completion percentage
timeFrame: 2 years
measure: Integration: Provider perception of feasibility
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: The Preston Robert Tisch Brain Tumor Center
state: North Carolina
Study officials:
affiliation: The Preston Robert Tisch Brain Tumor Center
name: Katherine Peters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palliative Care
name: David Casarett, MD, MA
role: PRINCIPAL_INVESTIGATOR
References: