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

Malignant Glioma Clinical Trial

Official title:

Recurrent High-grade Glioma: Experiences of Patients and Their Close Relatives During the Treatment Decision-making Process.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013828
• Other study ID #: OP870
• Status: Completed
• Start date: May 6, 2019
• Est. completion date: April 8, 2022

Study information

• Verified date: April 2022
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 8, 2022
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Life Experiences
• Malignant Glioma

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital; Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense

Sponsors (5)

Lead Sponsor	Collaborator
Odense University Hospital	Danish Cancer Society, Novo Nordisk A/S, Region of Southern Denmark, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experiences of patients and relatives	How patients and their close relatives experience the decision-making process	Interviews are performed 2-6 weeks after the decision-making
Primary	Involvement preferences	The preferences of patients and relatives for being involved in the decision-making.	Interviews are performed 2-6 weeks after the decision-making