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

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ClinicalTrials.gov Identifier: NCT04013828
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Region of Southern Denmark
Danish Cancer Society
Novo Nordisk A/S
Information provided by (Responsible Party):
Helle Sørensen von Essen, Odense University Hospital

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..

Condition or disease
Malignant Glioma Life Experiences

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.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Recurrent High-grade Glioma: Experiences of Patients and Their Close Relatives During the Treatment Decision-making Process.
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013828


Contacts
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Contact: Helle von Essen, PhD-student +45 2388 1722 helle.sorensen.von.essen@rsyd.dk
Contact: Karin Piil, Ass. profes. +45 3545 0733 Karin.Piil@regionh.dk

Locations
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Denmark
Copenhagen University Hospital; Rigshospitalet Not yet recruiting
Copenhagen, Denmark
Contact: Helle von Essen, PhD-student    +45 23881722    helle.sorensen.von.essen@rsyd.dk   
Odense University Hospital Recruiting
Odense, Denmark
Contact: Helle von Essen, PhD-student    +4523881722    helle.sorensen.von.essen@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Rigshospitalet, Denmark
Region of Southern Denmark
Danish Cancer Society
Novo Nordisk A/S
Investigators
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Study Director: Frantz Rom Poulsen, Professor Department of Neurosurgery Odense University Hospital DK-5000 Odense C DENMARK

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Responsible Party: Helle Sørensen von Essen, Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT04013828     History of Changes
Other Study ID Numbers: OP870
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helle Sørensen von Essen, Odense University Hospital:
High-grade glioma
Patient experiences
Decision-making
Patient involvement

Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue