Impact of the Development of Pediatric Palliative Care

Primary Brain Tumor Clinical Trial

— PTB  

Official title:

Assessment of the Presence of Symptoms of End-of-life Discomfort and Their Management in Children With a Primary Brain Tumor in the Grand Est Region. Impact of the Development of Pediatric Palliative Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660499
• Other study ID #: 8137
• Status: Recruiting
• Start date: February 15, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: Nadine COJEAN, MD
• Phone: 33 6 21 11 16 01
• Email: nadine.cojean[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Despite medical advances, cancer remains the leading cause of death by disease in children.

Brain tumors are the second most common cause of cancer in children after leukemia, representing 25% of pediatric cancers.

The overall survival rate is about 50% with extremes ranging from less than 5% to more than 90% depending on the histological type of brain tumor.

The end of life of children with a brain tumor is marked by the possibility of discomfort symptoms, painful or not, and by a progressive neurological deterioration, which makes the management of these children complex for both families and health professionals.

Over the last decade, the concept of palliative care has been increasingly integrated into pediatric onco-hematology services with the primary objective of better symptom control in a global approach to the child and his or her family in order to aim at a better quality of life.

Description:

The main objective of the study is to compare the occurrence and management of end-of-life symptoms in children who died of a primary brain tumor over 2 periods, in 2009 - 2010 and in 2019 - 2020, followed in the Pediatric Oncology departments of Strasbourg, Besançon, Dijon, Nancy and Reims.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

Inclusion criteria:

• Patient less than 17 years of age

• Suffering from a primary brain tumor

• Died during the period 2009-2010 or during the period 2019-2020

• Follow-up in one of the Pediatric Oncology departments participating in the study (Strasbourg, Besançon, Dijon, Nancy and Reims)

• Absence of refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes.

Exclusion criteria:

• Refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes

• Patient with a brain tumor secondary to another cancer

Related Conditions & MeSH terms

• Brain Neoplasms
• Primary Brain Tumor

Locations

Country	Name	City	State
France	Service de soins Palliatifs - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of symptoms of physical or psychological discomfort in the last 4 months of life		up to the last 4 months of life