Quality of Life of Children/Adolescents in Palliative Care Settings

• Conditions: Palliative Care
• Interventions: Other: Questionnaire

• Registration Number: NCT04527692
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Investigators will propose to each family monitored by the teams to participate in the study (children between 1 and 18 years old, families understanding and speaking a minimum of French).

Semi-directed interviews are organized with children/adolescents and their parents who have agreed to participate in the study. The interviews are conducted by the care teams themselves. Socio-demographic data are collected.

Detailed Description

An information letter will be distributed to the children and parents and their non opposition to their participation will be sought (or assent for the child via a written document adapted to the age) will be systematically requested.

Several instruments will be used by the members of the paediatric teams during their routine home or hospital visits to children and their families: the CPOS (Downing 2018), the KINDL (generic questionnaire on quality of life validated for healthy children, Erhart et al. 2009), the QOLLTI-F v.2 (questionnaire on quality of life for parents, Cohen 2007, 2015).

The interviews will therefore be semi-directed interviews with children/adolescents and their parents who have agreed to participate in the study. The interviews will be conducted by the care teams themselves. In addition to the CPOS, KINDL and QOOLTI-F, socio-demographic data are collected.

Study Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2020-07-29
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-24
• Last Update Submitted: 2020-08-24
• Study First Posted: 2020-08-26
• Last Update Posted: 2020-08-26
• Primary Completion: 2020-12-15
• Study Completion: 2022-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Children/adolescents aged 1 to 18 years with a serious illness and requiring follow-up by a regional pediatric palliative care resource team and/or temporarily hospitalized.
• Having given his non-opposition to his participation.
• A minor of whom at least one of the two holders of parental authority has given his or her consent to the participation of their child.
• Child of whom one of the two holders of parental authority has himself agreed to participate in the study.

Exclusion Criteria

• Children/adolescents at the end of life (imminent death foreseeable).
• Children/adolescents and their parents who do not understand French.
• Child or parent under legal protection (guardianship, curatorship).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Child	Questionnaire	Children/adolescents from 1 to 18 years of age with a serious illness requiring follow-up by a regional pediatric palliative care resource team and/or temporarily hospitalized.
Parents	Questionnaire	Adult person with parental authority over a child between the ages of 1 and 18 who is a carrier of a serious illness and requires follow-up by a regional pediatric palliative care resource team and/or is temporarily hospitalized.

Primary Outcome Measures

Name	Time	Method
Quality of life measure	Day 1	Exploring the quality of life of children/adolescents in palliative settings and that of their parents through the development of the Childrens palliative outcome scale.

Secondary Outcome Measures

Name	Time	Method
psychometric measure - KINDL	Day 1	using the validated questionnaire KINDL, French version
psychometric measure - QOLLTI-F	Day 1	using the the validated questionnaire Quality of life in life threatening illness-family caregiver QOLLTI-F.
psychometric measure - Children's palliative outcome scale	Day 1	Documentation of the psychometric properties of the Children's palliative outcome scale

Trial Locations

Locations (1)

Agnès SUC; 🇫🇷 Toulouse, France