Quality of Life and Patient Needs in Advanced High Grade Gliomas

NCT ID: NCT05039346

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-11

Study Completion Date

2023-01-30

Brief Summary

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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

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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.

Conditions

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Quality of Life Brain Tumor Glioblastoma Glioma Anaplastic Astrocytoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Phone interviews

Intervention Type OTHER

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

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.

Phone interviews

Intervention Type OTHER

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

Interventions

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Phone interviews

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Tobias Walbert, MD, PhD

Co-Director Hermelin Brain Tumor Center at the Henry Ford Cancer Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tobias Walbert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Other Identifiers

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IRB 14537

Identifier Type: -

Identifier Source: org_study_id

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