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

August 24, 2020 updated by: University Hospital, Toulouse

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Toulouse, France, 31059
        • Recruiting
        • Agnès SUC
        • Contact:
        • Principal Investigator:
          • Agnès SUC, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of life measure
Time Frame: 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.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
psychometric measure - KINDL
Time Frame: Day 1
using the validated questionnaire KINDL, French version
Day 1
psychometric measure - QOLLTI-F
Time Frame: Day 1
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
Time Frame: Day 1
Documentation of the psychometric properties of the Children's palliative outcome scale
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Agnes SUC, MD, Toulouse University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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