Quality of LifeNCT05039346
Quality of Life and Patient Needs in Advanced High Grade Gliomas
An observational study of Quality of Life and Brain Tumor, run by Henry Ford Health System.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Brain Tumor, Glioblastoma
- What is being tested?
- Phone interviews
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2012to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: Quality of Life and Patient Needs in Advanced High Grade Gliomas - A Prospective Study
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.
- Conditions
- Quality of Life, Brain Tumor, Glioblastoma, Glioma, Anaplastic Astrocytoma
- Being tested
- Phone interviews
- Medical subject headings
- Brain Neoplasms, Glioblastoma, Glioma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone interviewsOther
Phone interviews will be used to determine the patient's quality of life, symptoms and performance status
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Phone interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life and end of life symptoms in brain tumor patients
Assessment will be performed with validated questionnaire (MDASI-BT)
Measured: 12 months
Examination
Clinical assessment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start11 Feb 2012
- Primary completion26 Sep 2017
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Walbert, MD, PhD, Henry Ford Health System
- Investigators
- Tobias Walbert, MD, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039346
- Sponsor's protocol ID
- IRB 14537
- Status last verified
- Aug 2023
- First submitted
- 27 Aug 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Patient Needs in Advanced High Grade Gliomas - A Prospective Study
- ClinicalTrials.gov ID
- NCT05039346
- Acronym / sponsor ID
- IRB 14537
- Conditions
- Quality of Life, Brain Tumor, Glioblastoma, Glioma, Anaplastic Astrocytoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 11 Feb 2012 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Tumor | – | Other: Phone interviewsPatients 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 | – | Other: Phone interviewsShould 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone interviewsPhone interviews will be used to determine the patient's quality of life, symptoms and performance status | Other | Brain Tumor, Care Giver |
Primary outcome
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)
Examination
Time frame: 12 months
Clinical assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Walbert, MD, PhD principal investigator
Henry Ford Health System
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Brain Tumor, run by Henry Ford Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life and end of life symptoms in brain tumor patients (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.