Brain Neoplasms, Primary MalignantNCT01638130
Experiences and Needs of Patients With a High-grade Glioma and Their Caregivers
An observational study of Brain Neoplasms, Primary Malignant, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to explore the experiences and needs of patients with a high-grade glioma and their caregivers. Semi-structured interviews with patients and caregivers will be conducted and analysed using Grounded-Theory approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms, Primary Malignant
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2011to Jul 2025
- 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 with a high-grade glioma and their caregivers
Who may be able to join
- Adults
- Patients with a primary high-grade glioma who are treated with chemo or were treated with chemo
- Caregivers of patients with a primary high-grade glioma who are treated with chemo or were treated with chemo
- Able to be interviewed
- Dutch
Who cannot join
- Patients with cerebral metastases
- Patients and caregivers who withdraw their informed consent
- Emotionally and cognitive not being able to be interviewed
Trial locations and contacts
1 site in 1 country.
Wendy Sterckx contact
About this study
The purpose of this study is to explore the experiences and needs of patients with a high-grade glioma and their caregivers. Semi-structured interviews with patients and caregivers will be conducted and analysed using Grounded-Theory approach.
- Conditions
- Brain Neoplasms, Primary Malignant
- Medical subject headings
- Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startFeb 2011
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Neoplasms, Primary MalignantStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638130
- Sponsor's protocol ID
- B322201110320
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2012
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences and Needs of Patients With a High-grade Glioma and Their Caregivers
- ClinicalTrials.gov ID
- NCT01638130
- Acronym / sponsor ID
- B322201110320
- Conditions
- Brain Neoplasms, Primary Malignant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2011 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 11 Jul 2012 (estimated)
- 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.
The purpose of this study is to explore the experiences and needs of patients with a high-grade glioma and their caregivers. Semi-structured interviews with patients and caregivers will be conducted and analysed using Grounded-Theory approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a high-grade glioma and their caregivers
Key inclusion criteria (5 listed)
- Adults
- Patients with a primary high-grade glioma who are treated with chemo or were treated with chemo
- Caregivers of patients with a primary high-grade glioma who are treated with chemo or were treated with chemo
- Able to be interviewed
- Dutch
Key exclusion criteria (3 listed)
- Patients with cerebral metastases
- Patients and caregivers who withdraw their informed consent
- Emotionally and cognitive not being able to be interviewed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Wendy Sterckx contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasms, Primary Malignant, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy Sterckx (wendy.sterckx@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 3 Jul 2024.