Early Palliative Care Intervention in Malignant Glioma

Not Applicable

Completed

• Conditions: Malignant Glioma
• Interventions: Behavioral: Palliative Care

• Registration Number: NCT03471546
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-20
• Study Start: 2018-05-16
• Primary Completion: 2019-06-17
• Study Completion: 2019-06-17
• Status Verified: 2020-06
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Palliative care	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.

Primary Outcome Measures

Name	Time	Method
Acceptability: Continuation of follow-up with palliative care provider after initial consultation	8 months	The percentage of patients who continue to follow up with their palliative care provider after initial consultation among those who receive initial consultation.
Demand: Time to enroll 50 patients	2 years	The difference in months between the date the first patient is enrolled and the date the 50th patient is enrolled.
Implementation: Study completion percentage	2 years	The percentage of patients who complete all study-related questionnaires and procedures among those enrolled.
Integration: Provider perception of feasibility	2 years	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.
Acceptability: Provider satisfaction	8 months	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.
Demand: Enrollment percentage	2 years	The percentage of patients who choose to enroll in the study among those to which the study is offered.
Acceptability: Patient satisfaction	8 months	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.
Acceptability: Continuation of follow-up with palliative care provider beyond study period	8 months	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.

Trial Locations

Locations (1)

The Preston Robert Tisch Brain Tumor Center; 🇺🇸 Durham, North Carolina, United States