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OpenTrials
Completed

NCT Number: NCT05039346

Quality of Life and Patient Needs in Advanced High Grade Gliomas

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phone interviews

Other

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

Primary outcomes

  1. Quality of life and end of life symptoms in brain tumor patients

    Time frame: 12 months

    Assessment will be performed with validated questionnaire (MDASI-BT)

  2. Examination

    Time frame: 12 months

    Clinical assessment

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2023
First posted
Sep 9, 2021
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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