Early Palliative Care Intervention in Malignant Glioma

Malignant Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471546
• Other study ID #: Pro00091481
• Status: Completed
• Phase: N/A
• Start date: May 16, 2018
• Est. completion date: June 17, 2019

Study information

• Verified date: June 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 17, 2019
• Est. primary completion date: June 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

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

Locations

Country	Name	City	State
United States	The Preston Robert Tisch Brain Tumor Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Demand: Enrollment percentage	The percentage of patients who choose to enroll in the study among those to which the study is offered.	2 years
Primary	Implementation: Study completion percentage	The percentage of patients who complete all study-related questionnaires and procedures among those enrolled.	2 years
Primary	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

External Links

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