Palliative CareMOSAIKNCT04527692
Quality of Life of Children/Adolescents in Palliative Care Settings
An observational study of Palliative Care, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Palliative Care
- What is being tested?
- Questionnaire
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2020to 15 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Agnès SUC
Toulouse, 31059
Agnes SUC, MD, 05 34 55 86 61 ext. +33, suc.a@chu-toulouse.fr
Agnès SUC, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Questionnaire
- Keywords
- child, parents, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
semi-structured interviews on the quality of life
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire | |
| 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
psychometric measure - KINDL
using the validated questionnaire KINDL, French version
Measured: Day 1
psychometric measure - QOLLTI-F
using the the validated questionnaire Quality of life in life threatening illness-family caregiver QOLLTI-F.
Measured: Day 1
psychometric measure - Children's palliative outcome scale
Documentation of the psychometric properties of the Children's palliative outcome scale
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start15 Apr 2020
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnes SUC, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527692
- Sponsor's protocol ID
- RC31/19/0347
- Other IDs
- 2019-A02315-52
- Acronym
- MOSAIK
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Quality of Life of Children/Adolescents in Palliative Settings and That of Their Parents
- ClinicalTrials.gov ID
- NCT04527692
- Acronym / sponsor ID
- MOSAIK / RC31/19/0347
- Conditions
- Palliative Care
- Keywords
- child, parents, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child | – | Other: QuestionnaireChildren/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. |
| Parents | – | Other: QuestionnaireAdult 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairesemi-structured interviews on the quality of life | Other | Child, Parents |
Primary outcome
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.
3 secondary outcomes
psychometric measure - KINDL
Time frame: Day 1
psychometric measure - QOLLTI-F
Time frame: Day 1
psychometric measure - Children's palliative outcome scale
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes SUC, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnes SUC, MD (5 34 55 86 61 ext. +33, suc.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measure (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.