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

April 19, 2022 updated by: Helle Sørensen von Essen, Odense University Hospital

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..

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Copenhagen University Hospital; Rigshospitalet
      • Odense, Denmark
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
Patients with recurrent high-grade glioma
Relatives
Close relatives of patients with recurrent high-grade glioma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Interviews are performed 2-6 weeks after the decision-making
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.
Interviews are performed 2-6 weeks after the decision-making

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Novo Nordisk A/S
Rigshospitalet, Denmark
Danish Cancer Society
Region of Southern Denmark

Investigators

  • Study Director: Frantz Rom Poulsen, Professor, Department of Neurosurgery Odense University Hospital DK-5000 Odense C DENMARK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2019

Primary Completion (Actual)

April 3, 2020

Study Completion (Actual)

April 8, 2022

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP870

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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