Quality of Life and Patient Needs in Advanced High Grade Gliomas

Quality of Life and Patient Needs in Advanced High Grade Gliomas - A Prospective Study

There is limited knowledge regarding the quality of life and needs of patients with advanced high grade gliomas, especially during the end of life. By doing this research, we are able to assess caregiver and patient symptoms and needs during the end of life phase of patients with brain tumors.

Study Overview

• Status: Completed
• Conditions: Glioma; Quality of Life; Glioblastoma; Brain Tumor; Anaplastic Astrocytoma
• Intervention / Treatment: Other: Phone interviews

Detailed Description

Purpose: This is a pilot study to prospectively assess the symptoms and quality of life of patients and with advanced high grade glioma and their care takers.

Specific Aims: The aim of this study is to investigate the symptoms of patients with advanced high grade glioma. Patients who failed 3rd line chemotherapy and who require at least occasional assistance will be prospectively followed and their symptoms will be prospectively assessed. Patient's caregiver will be interviewed following the death of the patient to assess clinical symptoms in the last weeks of life and around the time of death.

Methods: Patients will undergo clinical symptom assessment via questionnaire. Patients will be followed by regular semi-structured phone interviews.

Should a patient pass, four weeks following this, the patient's care giver will be interviewed.

• Study Type: Observational
• Enrollment (Actual): 55

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients must have been diagnosed with a high grade brain tumor and must show signs of clinical progression. Patients who have failed 3rd line chemotherapy regimen and who require at least occasional assistance are invited to participate.

Description

Inclusion Criteria:

• Age >18
• Tissue proven diagnosis of a high grade brain tumor
• Disease progression by MRI
• Therapy resistant tumor to 2nd line chemotherapy
• Karnofsky Performance Scale (KPS) score of 60 or less
• Patient will need to assign caregiver

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brain Tumor; Patients who are diagnosed with a high grade glioma that is progressive and therapy resistance. Patients will have a KPS of 60 or less.	Other: Phone interviews; Phone interviews will be used to determine the patient's quality of life, symptoms and performance status
Care Giver; Should a patient be unable to answer, the care giver will step in and provide surrogate answers. Additionally, at four weeks following the patient's death, the patient's care giver will be interviewed by utilizing a validated questionnaire.	Other: Phone interviews; Phone interviews will be used to determine the patient's quality of life, symptoms and performance status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life and end of life symptoms in brain tumor patients	Assessment will be performed with validated questionnaire (MDASI-BT)	12 months
Examination	Clinical assessment	12 months

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Tobias Walbert, MD, PhD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2012
• Primary Completion (Actual): September 26, 2017
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma; Astrocytoma
• Other Study ID Numbers: IRB 14537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No