ChildFCENCT04065542
Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old
An observational study of Child and Determinants of Health, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Model and map, from a qualitative multi-phased protocol, the conceptions and systems of conceptions of the determinants of health and cancer expressed and perceived by schoolchildren aged 6 to 11 years. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Child, Determinants of Health, Qualitative Research
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 6 to 11 years
- All sexes
- Child
Study population: chidren
Who may be able to join
- School volunteering to participate in the project Primary school
- children aged 6 to 11
- Girls and boys
- All school levels Private and public primary school
- Rural and urban primary school
Who cannot join
- Class ULIS
- Students who benefit from a personalized support plan
- Individual refusal of participation (child and / or family)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Lise LACLAUTRE
Clermont-Ferrand, 63000
Lise Laclautre, 0473754963, promo-interne-drci@chu-clermontferrand.fr
Frank PIZON, MCF HDR
About this study
Model and map, from a qualitative multi-phased protocol, the conceptions and systems of conceptions of the determinants of health and cancer expressed and perceived by schoolchildren aged 6 to 11 years. The secondary objectives are to analyze the ability to question the conceptions of children's health regardless of their age and to link conceptions and determinants to contextual factors. The informative value and complementarity of the collection tools (photo expression, QC, photo-narration) and the relevance of a mixed analysis methodology (qualitative and quantitative) in order to highlight the different determinants of health will also be studied.
Read the detailed description
Qualitative observational study of human and social sciences (SHS), multicenter, conducted with schoolchildren.
The qualitative methodology used combines the use of photographs, open questionnaires and focus groups, over very large panels, aiming at both diversity and representativeness.
- Photo expression: to identify the determinants perceived as having a positive or negative influence on one's health;
- CQR : Certainty/Question/Rumour on how to take care of one's health (health promotion input following on from school policies, i.e. PES: Politique d'Etablissements Scolaires);
- Photo narration: to identify argumentative frameworks in health and alternatives perceived as being positive or negative for one's health,
- Focus groups: to improve understanding of the rationalities built by adolescents in relation to that which determines their health.
This choice is justified by the need to explore and understand the actions from the participants' point of view.
The diversity of schools and pupils (5 classes in 4 schools in the AURA region, i.e. 320 pupils) will make it possible to obtain the data saturation required in qualitative research.
This makes it possible to consider a mixed analysis strategy, both qualitative and quantitative.
This project aims to better understand the rationalities elaborated by children and the way in which their concepts on the determinants of cancer interlink, as well as to describe the declared impact these concepts have on the decision-making regarding their health.
- Conditions
- Child, Determinants of Health, Qualitative Research, Cancer
- Keywords
- Social behaviour, Qualitative research, Child, Cancer
- Medical subject headings
- Neoplasms, Social Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
categorized groups by genre according to the Relation to the environment criteria
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
Measured: day 1
categorized groups by genre according to a Factors of fulfillment and personal development criteria
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
Measured: day 1
categorized groups by genre according to the link with a healt theme criteria
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
Measured: day 1
categorized groups by genre according to Care activities criteria
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
Measured: day 1
categorized groups by genre according to a Recommendation and support in health in the social sphere criteria
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
Measured: day 1
categorized groups by genre according to an health capital criteria
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
Measured: day 1
categorized groups by genre according to the emotional dimension in social relations criteria
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
Measured: day 1
Secondary outcomes (3)
Incidence of children able to explain their health regardless of their age
The informative value and complementarity of the collection tools (photo The informative value are measured with collection tools (photo expression, photo-narration) and a mixed analysis methodology (qualitative and quantitative) is used in order to highlight the different determinants of health.
Measured: Day 1
Incidence of children able to explain their health regardless of their contextual factors
The informative value are measured with collection tools (photo expression, photo-narration) and a mixed analysis methodology (qualitative and quantitative) is used in order to highlight the different determinants of health.
Measured: Day 1
Identify child profile
Identify child profiles / classes / school based :• Socio-demographic data (class / age, sex, class size, number of male and female, school enrollment, class number, geographical location, priority education, team stability, health project, type of project, impression of researchers)
- Domains or designs: Individual \& collective Domains created during the qualitative analysis
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 posted22 Aug 2019
- Study start1 Jan 2019
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Auvergne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065542
- Sponsor's protocol ID
- 2019 FCE
- Acronym
- FCE
- Status last verified
- May 2019
- First submitted
- 28 May 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old
- ClinicalTrials.gov ID
- NCT04065542
- Acronym / sponsor ID
- FCE / 2019 FCE
- Conditions
- Child, Determinants of Health, Qualitative Research, Cancer
- Keywords
- Social behaviour, Qualitative research, Child, Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Université d'Auvergne
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 22 Aug 2019 (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.
Model and map, from a qualitative multi-phased protocol, the conceptions and systems of conceptions of the determinants of health and cancer expressed and perceived by schoolchildren aged 6 to 11 years. The secondary objectives are to analyze the ability to question the conceptions of children's health regardless of their age and to link conceptions and determinants to contextual factors. The informative value and complementarity of the collection tools (photo expression, QC, photo-narration) and the relevance of a mixed analysis methodology (qualitative and quantitative) in order to highlight the different determinants of health will also be studied.
Detailed description
Qualitative observational study of human and social sciences (SHS), multicenter, conducted with schoolchildren.
The qualitative methodology used combines the use of photographs, open questionnaires and focus groups, over very large panels, aiming at both diversity and representativeness.
- Photo expression: to identify the determinants perceived as having a positive or negative influence on one's health;
- CQR : Certainty/Question/Rumour on how to take care of one's health (health promotion input following on from school policies, i.e. PES: Politique d'Etablissements Scolaires);
- Photo narration: to identify argumentative frameworks in health and alternatives perceived as being positive or negative for one's health,
- Focus groups: to improve understanding of the rationalities built by adolescents in relation to that which determines their health.
This choice is justified by the need to explore and understand the actions from the participants' point of view.
The diversity of schools and pupils (5 classes in 4 schools in the AURA region, i.e. 320 pupils) will make it possible to obtain the data saturation required in qualitative research.
This makes it possible to consider a mixed analysis strategy, both qualitative and quantitative.
This project aims to better understand the rationalities elaborated by children and the way in which their concepts on the determinants of cancer interlink, as well as to describe the declared impact these concepts have on the decision-making regarding their health.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Age groups
- Child
- Study population
- chidren
Key inclusion criteria (5 listed)
- School volunteering to participate in the project Primary school
- children aged 6 to 11
- Girls and boys
- All school levels Private and public primary school
- Rural and urban primary school
Key exclusion criteria (3 listed)
- Class ULIS
- Students who benefit from a personalized support plan
- Individual refusal of participation (child and / or family)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
categorized groups by genre according to the Relation to the environment criteria
Time frame: day 1
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
categorized groups by genre according to a Factors of fulfillment and personal development criteria
Time frame: day 1
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
categorized groups by genre according to the link with a healt theme criteria
Time frame: day 1
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
categorized groups by genre according to Care activities criteria
Time frame: day 1
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
categorized groups by genre according to a Recommendation and support in health in the social sphere criteria
Time frame: day 1
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
categorized groups by genre according to an health capital criteria
Time frame: day 1
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
categorized groups by genre according to the emotional dimension in social relations criteria
Time frame: day 1
The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.
3 secondary outcomes
Incidence of children able to explain their health regardless of their age
Time frame: Day 1
Incidence of children able to explain their health regardless of their contextual factors
Time frame: Day 1
Identify child profile
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 22 Aug 2019.
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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.
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 Child and Determinants of Health, run by University Hospital, Clermont-Ferrand 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 5 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 22 Aug 2019. 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 Lise Laclautre (0473754963, promo-interne-drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
categorized groups by genre according to the Relation to the environment criteria (time frame: day 1). The study lists 7 primary outcomes in all. 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 22 Aug 2019.