Early Palliative Care Intervention in Malignant Glioma

• ClinicalTrials.gov Identifier: NCT03471546
• Recruitment Status: Completed
• First Posted: March 20, 2018
• Last Update Posted: November 24, 2020
• Sponsor: Duke University
• Collaborator: Duke Cancer Institute
• Information provided by (Responsible Party): Duke University

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.

Condition or disease	Intervention/treatment	Phase
Malignant Glioma	Behavioral: Palliative Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Model of Early Palliative Care Intervention in Patients With Newly Diagnosed WHO Grade IV Malignant Glioma, a Single Arm Feasibility Study
• Actual Study Start Date: May 16, 2018
• Actual Primary Completion Date: June 17, 2019
• Actual Study Completion Date: June 17, 2019

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

The Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Duke Cancer Institute

Investigators

• Principal Investigator: Katherine Peters, MD, PhD; The Preston Robert Tisch Brain Tumor Center
• Principal Investigator: David Casarett, MD, MA; Palliative Care

More Information

Additional Information:

The Preston Robert Tisch Brain Tumor Center at Duke 

Study Results 

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03471546
• Other Study ID Numbers: Pro00091481
• First Posted: March 20, 2018
• Last Update Posted: November 24, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:

Palliative Care; Pro00091481; Malignant Glioma; Katherine Peters; David Casarett

Additional relevant MeSH terms:

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue