Malignant GliomaNCT04013828
Treatment Decision-making in Patients With Recurrent High-grade Glioma
An observational study of Malignant Glioma and Life Experiences, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
This qualitative study explores the lived experience of high-grade glioma patients and their close relatives at time of recurrence. With focus on the decision-making about treatment and care.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma, Life Experiences
- How many people
- 29 participants
- Where
- 2 sitesDenmark
- Study dates
- 6 May 2019to 8 Apr 2022
- 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: Two study populations: 1. - Adult patients with recurrence of high-grade glioma who are offered surgical treatment as one of the treatment possibilities. 2. - The adult relative most involved in the decision-making. The relative is apointed by the patient and the patient gives written concent to the relative' participation.
Who may be able to join
- The patient is offered surgical treatment (after an assesment done by the multidisciplinary team)
- Able to speak and understand danish
- Able to participate in an interview
- Able to give informed concent for participation
Who cannot join
- Patients with severe cognitive impairment which prohibits them from either giving informed concent or participating in interview.
- Relatives are excluded if the patient do not give concent for the participation of relatives
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copenhagen University Hospital; Rigshospitalet
Copenhagen
Odense University Hospital
Odense
About this study
Official title: Recurrent High-grade Glioma: Experiences of Patients and Their Close Relatives During the Treatment Decision-making Process.
This qualitative study explores the lived experience of high-grade glioma patients and their close relatives at time of recurrence. With focus on the decision-making about treatment and care..
Read the detailed description
High-Grade Glioma is a life-threatening disease that can cause the patient substantial physical, mentally and psychosocially impairment. The life expectancy is short, and a majority of patients experience recurrence of tumour growth. At time of recurrence, the treatment possibilities can include surgery, oncological treatment and/or palliative care.
In this situation the patients and their close relatives need to make a difficult balancing between benefits and trade offs.
Little is known about how the patients and their close relatives experience the recurrence and the decision-making process.
The objective of this study is therefore to explore the perspectives, experiences and needs in patients and their close relatives in relation to the decision-making process at time of recurrence.
Data will be generated through semi-structured interviews. Interviews will be analysed and interpreted using a Ricoeur inspired method of qualitative analysis.
The study is part of a larger PhD-study.
- Conditions
- Malignant Glioma, Life Experiences
- Keywords
- High-grade glioma, Patient experiences, Decision-making, Patient involvement
- Medical subject headings
- Glioma, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with recurrent high-grade glioma | |
| Relatives | Close relatives of patients with recurrent high-grade glioma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences of patients and relatives
How patients and their close relatives experience the decision-making process
Measured: Interviews are performed 2-6 weeks after the decision-making
Involvement preferences
The preferences of patients and relatives for being involved in the decision-making.
Measured: Interviews are performed 2-6 weeks after the decision-making
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start6 May 2019
- Primary completion3 Apr 2020
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Region of Southern Denmark, Danish Cancer Society, Novo Nordisk A/S
- Responsible party
- Principal investigator, Helle Sørensen von Essen, Odense University Hospital
- Investigators
- Frantz Rom Poulsen, Professor, Study director, Department of Neurosurgery Odense University Hospital DK-5000 Odense C DENMARK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013828
- Sponsor's protocol ID
- OP870
- Status last verified
- Apr 2022
- First submitted
- 8 Jul 2019
- Last updated
- 20 Apr 2022
- Results posted
- 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent High-grade Glioma: Experiences of Patients and Their Close Relatives During the Treatment Decision-making Process.
- ClinicalTrials.gov ID
- NCT04013828
- Acronym / sponsor ID
- OP870
- Conditions
- Malignant Glioma, Life Experiences
- Keywords
- High-grade glioma, Patient experiences, Decision-making, Patient involvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Region of Southern Denmark, Danish Cancer Society, Novo Nordisk A/S
- Study start
- 6 May 2019 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 10 Jul 2019 (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.
This qualitative study explores the lived experience of high-grade glioma patients and their close relatives at time of recurrence. With focus on the decision-making about treatment and care..
Detailed description
High-Grade Glioma is a life-threatening disease that can cause the patient substantial physical, mentally and psychosocially impairment. The life expectancy is short, and a majority of patients experience recurrence of tumour growth. At time of recurrence, the treatment possibilities can include surgery, oncological treatment and/or palliative care.
In this situation the patients and their close relatives need to make a difficult balancing between benefits and trade offs.
Little is known about how the patients and their close relatives experience the recurrence and the decision-making process.
The objective of this study is therefore to explore the perspectives, experiences and needs in patients and their close relatives in relation to the decision-making process at time of recurrence.
Data will be generated through semi-structured interviews. Interviews will be analysed and interpreted using a Ricoeur inspired method of qualitative analysis.
The study is part of a larger PhD-study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with recurrent high-grade glioma |
| Relatives | – | –Close relatives of patients with recurrent high-grade glioma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two study populations: 1. - Adult patients with recurrence of high-grade glioma who are offered surgical treatment as one of the treatment possibilities. 2. - The adult relative most involved in the decision-making. The relative is apointed by the patient and the patient gives written concent to the relative' participation.
Key inclusion criteria (4 listed)
- The patient is offered surgical treatment (after an assesment done by the multidisciplinary team)
- Able to speak and understand danish
- Able to participate in an interview
- Able to give informed concent for participation
Key exclusion criteria (2 listed)
- Patients with severe cognitive impairment which prohibits them from either giving informed concent or participating in interview.
- Relatives are excluded if the patient do not give concent for the participation of relatives
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
Experiences of patients and relatives
Time frame: Interviews are performed 2-6 weeks after the decision-making
How patients and their close relatives experience the decision-making process
Involvement preferences
Time frame: Interviews are performed 2-6 weeks after the decision-making
The preferences of patients and relatives for being involved in the decision-making.
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 20 Apr 2022.
- 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.
Frantz Rom Poulsen, Professor study director
Department of Neurosurgery Odense University Hospital DK-5000 Odense C DENMARK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Glioma and Life Experiences, run by Odense University Hospital at 2 sites in Denmark.
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 4 inclusion and 2 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 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
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?
Experiences of patients and relatives (time frame: Interviews are performed 2-6 weeks after the decision-making). 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 20 Apr 2022.