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Early Palliative Care Intervention in Malignant Glioma

NCT ID: NCT03471546

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-16

Study Completion Date

2019-06-17

Brief Summary

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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

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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.

Conditions

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Malignant Glioma

Keywords

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Palliative Care Pro00091481 Malignant Glioma Katherine Peters David Casarett

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Palliative Care

Intervention Type BEHAVIORAL

Initial consultation and follow-up with a palliative care provider

Interventions

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Palliative Care

Initial consultation and follow-up with a palliative care provider

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke Cancer Institute

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine Peters, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Preston Robert Tisch Brain Tumor Center

David Casarett, MD, MA

Role: PRINCIPAL_INVESTIGATOR

Palliative Care

Locations

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The Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Related Links

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https://tischbraintumorcenter.duke.edu/

The Preston Robert Tisch Brain Tumor Center at Duke

Other Identifiers

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Pro00091481

Identifier Type: -

Identifier Source: org_study_id