Quality of Life and Patient Needs in Advanced High Grade Gliomas

NCT05039346 | Completed

• 1 other identifier: IRB 14537
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Quality of Life; Brain Tumor; Glioblastoma; Glioma; Anaplastic Astrocytoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Phone interviews OTHER

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

Brain Tumor; Care Giver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Henry Ford Health System: lead

MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma; Glioma; Astrocytoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Tobias Walbert, MD, PhD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director Hermelin Brain Tumor Center at the Henry Ford Cancer Institute

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 9, 2021
• Study Start: February 11, 2012
• Primary Completion: September 26, 2017
• Study Completion: January 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share