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CompletedNCT05039346Updated Aug 14, 2023

Quality of Life and Patient Needs in Advanced High Grade Gliomas

An observational study in Quality of Life, Brain Tumor and Glioblastoma, sponsored by Henry Ford Health System. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Henry Ford Health System · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
55
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Quality of Life
  • Brain Tumor
  • Glioblastoma
  • Glioma
  • Anaplastic Astrocytoma
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 55 is close to the median of 60 across 188 observational studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
55 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • OtherPhone interviews

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: 12 months

  2. Examination

    Clinical assessment

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05039346
Lead sponsor
Henry Ford Health System
Responsible party
Tobias Walbert, MD, PhD (Co-Director Hermelin Brain Tumor Center at the Henry Ford Cancer Institute, Henry Ford Health System) — Principal investigator
First posted
Sep 9, 2021
Start date
Feb 11, 2012
Primary completion
Sep 26, 2017
Completion
Jan 30, 2023
Last update
Aug 14, 2023

Study contacts

Tobias Walbert, MD, PhD
principal investigator · Henry Ford Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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