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Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old (FCE)

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ClinicalTrials.gov Identifier: NCT04065542
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Université d'Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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. 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.

Condition or disease
Child Determinants of Health Qualitative Research Cancer

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.

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. Incidence of children able to explain their health regardless of their age [ Time Frame: Day 1 ]
    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.

  2. Incidence of children able to explain their health regardless of their contextual factors [ Time Frame: Day 1 ]
    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.

  3. Identify child profile [ Time Frame: Day 1 ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
chidren
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Class ULIS
  • Students who benefit from a personalized support plan
  • Individual refusal of participation (child and / or family)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065542


Contacts
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Contact: Lise Laclautre 0473754963 promo-interne-drci@chu-clermontferrand.fr

Locations
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France
Lise LACLAUTRE Recruiting
Clermont-Ferrand, France, 63000
Contact: Lise Laclautre    0473754963    promo-interne-drci@chu-clermontferrand.fr   
Principal Investigator: Frank PIZON, MCF HDR         
Sub-Investigator: Laurent GERBAUD, PU PH         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Université d'Auvergne
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04065542    
Other Study ID Numbers: 2019 FCE
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Social behaviour
Qualitative research
Child
Cancer