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Quality of Life and Patient Needs in Advanced High Grade Gliomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05039346
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Henry Ford Health System
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tobias Walbert, MD, PhD
Principal Investigator Affiliation	Henry Ford Health System
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Completed
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Quality of Life, Brain Tumor, Glioblastoma, Glioma, Anaplastic Astrocytoma

Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.

Interventions

Other: - Phone interviews

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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