Early Palliative Care Intervention in Malignant Glioma

NCT03471546 | Completed

• 1 other identifier: Pro00091481
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Glioma

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• Demand: Enrollment percentage

  The percentage of patients who choose to enroll in the study among those to which the study is offered.

  2 years

• Implementation: Study completion percentage

  The percentage of patients who complete all study-related questionnaires and procedures among those enrolled.

  2 years

• 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

Study Arms (1)

Palliative care

EXPERIMENTAL

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

Interventions

Palliative Care BEHAVIORAL

Initial consultation and follow-up with a palliative care provider

Palliative care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• Patient who currently has a PC provider and/or is receiving hospice care or plans on initiating hospice at the time of enrollment

Sponsors & Collaborators

• Duke University: lead
• Duke Cancer Institute: collaborator

Study Sites (1)

The Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, 27710, United States

Location

Related Links

• The Preston Robert Tisch Brain Tumor Center at Duke

MeSH Terms

Conditions

Glioma

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Katherine Peters, MD, PhD

  The Preston Robert Tisch Brain Tumor Center

  PRINCIPAL INVESTIGATOR

• David Casarett, MD, MA

  Palliative Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 20, 2018
• Study Start: May 16, 2018
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: November 24, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)