Quality of Life of Children/Adolescents in Palliative Care Settings

NCT ID: NCT04527692

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-15
• Study Completion Date: 2022-11-15

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.

Conditions

Palliative Care

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Questionnaire

Intervention Type: OTHER

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.

Questionnaire

Intervention Type: OTHER

semi-structured interviews on the quality of life

Interventions

Questionnaire

semi-structured interviews on the quality of life

Intervention Type: OTHER

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).

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnes SUC, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Agnès SUC

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Agnes SUC, MD

Role: CONTACT

suc.a@chu-toulouse.fr

5 34 55 86 61 ext. +33

Facility Contacts

Agnes SUC, MD

Role: primary

suc.a@chu-toulouse.fr

05 34 55 86 61 ext. +33

Other Identifiers

2019-A02315-52

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/19/0347

Identifier Type: -

Identifier Source: org_study_id