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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04527692
Other study ID # RC31/19/0347
Secondary ID 2019-A02315-52
Status Recruiting
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date November 15, 2022

Study information

Verified date August 2020
Source University Hospital, Toulouse
Contact Agnes SUC, MD
Phone 5 34 55 86 61
Email suc.a@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date November 15, 2022
Est. primary completion date December 15, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
semi-structured interviews on the quality of life

Locations

Country Name City State
France Agnès SUC Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

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