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NCT05039346 Clinical Trial

Quality of Life and Patient Needs in Advanced High Grade Gliomas

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05039346
Other study ID # IRB 14537
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 11, 2012
Est. completion date January 30, 2023

Study information
Verified date August 2023
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date January 30, 2023
Est. primary completion date September 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Phone interviews
Phone interviews will be used to determine the patient's quality of life, symptoms and performance status

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Henry Ford Health System

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