Clinical trial NCT04013828: Treatment Decision-making in Patients With Recurrent High-grade Glioma
Official title: Recurrent High-grade Glioma: Experiences of Patients and Their Close Relatives During the Treatment Decision-making Process.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Glioma
Life Experiences
Keywords: High-grade glioma
Patient experiences
Decision-making
Patient involvement
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Region of Southern Denmark
name: Danish Cancer Society
name: Novo Nordisk A/S
First posted: 2019-07-10
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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..

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.

Eligibility 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

Primary outcomes:
measure: Experiences of patients and relatives
timeFrame: Interviews are performed 2-6 weeks after the decision-making
measure: Involvement preferences
timeFrame: Interviews are performed 2-6 weeks after the decision-making
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital; Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Department of Neurosurgery Odense University Hospital DK-5000 Odense C DENMARK
name: Frantz Rom Poulsen, Professor
role: STUDY_DIRECTOR
References: