Quality of Life of Children/Adolescents in Palliative Care Settings (MOSAIK)

Exploring the Quality of Life of Children/Adolescents in Palliative Settings and That of Their Parents

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.

Study Overview

• Status: Unknown
• Conditions: Palliative Care
• Intervention / Treatment: Other: Questionnaire

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 Type: Observational
• Enrollment (Anticipated): 320

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Agnès SUC
    • Contact: Agnes SUC, MD; Phone Number: +33 05 34 55 86 61; Email: suc.a@chu-toulouse.fr
    • Principal Investigator: Agnès SUC, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Child; 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.	Other: Questionnaire; semi-structured interviews on the quality of life
Parents; 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.	Other: Questionnaire; semi-structured interviews on the quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measure	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.	Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Agnes SUC, MD, Toulouse University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2020
• Primary Completion (ANTICIPATED): December 15, 2020
• Study Completion (ANTICIPATED): November 15, 2022

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (ACTUAL): August 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; parents; child
• Other Study ID Numbers: RC31/19/0347; 2019-A02315-52 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No