Treatment Decision-making in Patients With Recurrent High-grade Glioma

Study Purpose

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..

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:

  • - 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.

Exclusion Criteria:

  • - 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 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.

NCT04013828
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.

Odense University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Frantz Rom Poulsen, Professor
Principal Investigator Affiliation Department of Neurosurgery Odense University Hospital DK-5000 Odense C DENMARK
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Glioma, Life Experiences
Additional Details

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.

Arms & Interventions

Arms

: Patients

Patients with recurrent high-grade glioma

: Relatives

Close relatives of patients with recurrent high-grade glioma

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Copenhagen, Denmark

Status

Not yet recruiting

Address

Copenhagen University Hospital; Rigshospitalet

Copenhagen, ,

Site Contact

Helle von Essen, PhD-student

helle.sorensen.von.essen@rsyd.dk

+45 23881722

Odense University Hospital, Odense, Denmark

Status

Recruiting

Address

Odense University Hospital

Odense, ,

Site Contact

Helle von Essen, PhD-student

helle.sorensen.von.essen@rsyd.dk

+4523881722

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