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

NCT04013828 | Completed

• 1 other identifier: OP870
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 2

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..

Conditions

Malignant Glioma; Life Experiences

Keywords

High-grade glioma; Patient experiences; Decision-making; Patient involvement

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Patients

Patients with recurrent high-grade glioma

Relatives

Close relatives of patients with recurrent high-grade glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Region of Southern Denmark: collaborator
• Danish Cancer Society: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (2)

Copenhagen University Hospital; Rigshospitalet

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

Glioma; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Frantz Rom Poulsen, Professor

  Department of Neurosurgery Odense University Hospital DK-5000 Odense C DENMARK

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: May 6, 2019
• Primary Completion: April 3, 2020
• Study Completion: April 8, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)