Quality of Life and Patient Needs in Advanced High Grade Gliomas

Completed

• Conditions: Quality of Life; Brain Tumor; Anaplastic Astrocytoma; Glioma; Glioblastoma
• Interventions: Other: Phone interviews

• Registration Number: NCT05039346
• Lead Sponsor: Henry Ford Health System

Brief Summary

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.

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 Timeline

• Study Start: 2012-02-11
• Primary Completion: 2017-09-26
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-09
• Study Completion: 2023-01-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Care Giver	Phone interviews	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.
Brain Tumor	Phone interviews	Patients who are diagnosed with a high grade glioma that is progressive and therapy resistance. Patients will have a KPS of 60 or less.

Primary Outcome Measures

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