Clinical trial NCT04527692: Quality of Life of Children/Adolescents in Palliative Care Settings
Official title: Exploring the Quality of Life of Children/Adolescents in Palliative Settings and That of Their Parents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Palliative Care
Keywords: child
parents
quality of life
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 320
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Child/parent pair agrees to participate, they give their agreement orally and their non-opposition is documented in the patient's medical record.

Interviews are conducted at home and/or at the hospital depending on where the child is usually cared for by the usual care team.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Quality of life measure
timeFrame: Day 1
Secondary outcomes:
measure: psychometric measure - KINDL
timeFrame: Day 1
measure: psychometric measure - QOLLTI-F
timeFrame: Day 1
measure: psychometric measure - Children's palliative outcome scale
timeFrame: Day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Agnès SUC
Study officials:
affiliation: University Hospital, Toulouse
name: Agnes SUC, MD
role: PRINCIPAL_INVESTIGATOR
References: