- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065542
Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old (FCE)
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lise Laclautre
- Phone Number: 0473754963
- Email: promo-interne-drci@chu-clermontferrand.fr
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- Recruiting
- Lise LACLAUTRE
-
Contact:
- Lise Laclautre
- Phone Number: 0473754963
- Email: promo-interne-drci@chu-clermontferrand.fr
-
Principal Investigator:
- Frank PIZON, MCF HDR
-
Sub-Investigator:
- Laurent GERBAUD, PU PH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
day 1
|
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.
|
day 1
|
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.
|
day 1
|
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.
|
day 1
|
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.
|
day 1
|
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.
|
day 1
|
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.
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1
|
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.
|
Day 1
|
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 |
Day 1
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019 FCE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States