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Early Palliative Care Intervention in Malignant Glioma

Primary Purpose

Malignant Glioma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative Care
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Glioma focused on measuring Palliative Care, Pro00091481, Malignant Glioma, Katherine Peters, David Casarett

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Preston Robert Tisch Brain Tumor Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Palliative care

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Demand: Enrollment percentage
The percentage of patients who choose to enroll in the study among those to which the study is offered.
Implementation: Study completion percentage
The percentage of patients who complete all study-related questionnaires and procedures among those enrolled.
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.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2018
Last Updated
November 23, 2020
Sponsor
Duke University
Collaborators
Duke Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03471546
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
June 17, 2019 (Actual)
Study Completion Date
June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Duke Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma
Keywords
Palliative Care, Pro00091481, Malignant Glioma, Katherine Peters, David Casarett

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palliative care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Palliative Care
Intervention Description
Initial consultation and follow-up with a palliative care provider
Primary Outcome Measure Information:
Title
Acceptability: Patient satisfaction
Description
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.
Time Frame
8 months
Title
Acceptability: Provider satisfaction
Description
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.
Time Frame
8 months
Title
Acceptability: Continuation of follow-up with palliative care provider after initial consultation
Description
The percentage of patients who continue to follow up with their palliative care provider after initial consultation among those who receive initial consultation.
Time Frame
8 months
Title
Acceptability: Continuation of follow-up with palliative care provider beyond study period
Description
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.
Time Frame
8 months
Title
Demand: Time to enroll 50 patients
Description
The difference in months between the date the first patient is enrolled and the date the 50th patient is enrolled.
Time Frame
2 years
Title
Demand: Enrollment percentage
Description
The percentage of patients who choose to enroll in the study among those to which the study is offered.
Time Frame
2 years
Title
Implementation: Study completion percentage
Description
The percentage of patients who complete all study-related questionnaires and procedures among those enrolled.
Time Frame
2 years
Title
Integration: Provider perception of feasibility
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Peters, MD, PhD
Organizational Affiliation
The Preston Robert Tisch Brain Tumor Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Casarett, MD, MA
Organizational Affiliation
Palliative Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Preston Robert Tisch Brain Tumor Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://tischbraintumorcenter.duke.edu/
Description
The Preston Robert Tisch Brain Tumor Center at Duke
URL
https://academic.oup.com/neuro-oncology/article/21/Supplement_6/vi201/5619860
Description
Study Results

Learn more about this trial

Early Palliative Care Intervention in Malignant Glioma

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